Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

Continuing the 510(k) premarket notifications list, 1000 records per page.

  1. K934434CYBERRX MODEL 7200
  2. K170223Progreat
  3. K230414ClariVy™ Cervical IBF System
  4. K191367Harrier-SA Lumbar Interbody System
  5. K062228ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
  6. K962713DPAP STEALTH SLEEPNET MODEL NUMBER 84000
  7. K001955AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
  8. K213873SkyWalker Total Knee System
  9. K081551TWIN NEUROTRAC-III
  10. K983893POWDERED VINYL EXAMINATION GLOVE
  11. K010403PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
  12. K143752Total Knee Application (TKA)
  13. K173365Bausch + Lomb Boston Scleral Lens Case
  14. K821763SHUR-STRIP APPLICATOR
  15. BK060007Peripheral blood processing device for wound management
  16. K020522MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
  17. K063710SATURN 9000
  18. K181655Renovis S180 Lateral Lumbar Interbody Fusion System
  19. K960663UNIVERSAL BITE BLOCK
  20. K041848POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
  21. K822535CIDEX*DIALYZER DISINFECTING SOLUTION
  22. K203500RetCam Envision
  23. K953628PROPHY ANGLE
  24. K110172SONAFINE WOUND DRESSING
  25. K000977COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
  26. K945934URESIL(R) GUIDEWIRE
  27. K781776PACING LEADS MODEL UL-811 AND UL-813
  28. BK170096Platelet And Plasma Separator For Bone Graft Handling
  29. K173633VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack…
  30. K252677Polyshield Safety IV Catheters
  31. K963550RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
  32. K110322OLECRA INTRAMEDULLARY FIXATION SYSTEM
  33. K030428ROCHE ONLINE TDM PHENYTOIN
  34. K830253END TIDAL CO2 ANALYZER #411
  35. K010522SUREVUE URINE HCG
  36. K843920FLUOROSCAN/TM BY HEALTHMATE
  37. K862013STANDING WHEELER
  38. K172299Accordion Piccolo Stone Management Device
  39. K821698TDX NETILMICIN
  40. K071479SBI STAFIX
  41. K921414TROKEL /3 GONIO LASER LENS
  42. BK220752System, Test, Automated Blood Grouping and Antibody
  43. K831640WASHER 6000 MICRO-C LISA SYSTEM
  44. K893739VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
  45. K202838Andorate Universal Endoscope Tip Guard
  46. K253769Instylla Delivery Kit
  47. K001593MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
  48. K871777VAN-TEC REUSABLE HELICAL STONE BASKET
  49. K883432IMMUNOCCULT-LXI
  50. K971620QUANTA LITE RUBEOLA (MEASLES) IGG
  51. K894760CLOTHINGUARD
  52. K760706MUL-T-PAD
  53. K862279EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
  54. K252105Ligence Heart
  55. K131451PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
  56. K190044VSP Orthopedics System
  57. K971699ARGOSY DYNAMEQ
  58. K893379XENOS MOBILECAM
  59. K780154NEEDLEHOLDER, MICROVASULAR 5 1/2
  60. K961923BERENSTEIN COIL
  61. K926535GOMCO CIRCUMCISION CLAMP
  62. K173467Advanced Diffusion Analysis (ADA) application
  63. K935788BICORE SMARTCATH INTRATRACHEAL CATHETER
  64. K891474TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION
  65. K861806MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
  66. K960524ALTA CFX IM ROD SYSTEM
  67. K140490CIVA SHEET PD-103
  68. K060226ONCOR EXPRESSION
  69. K983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
  70. K955143RPR LIQUID CONTROLS
  71. K9650433M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG…
  72. K924028LAPAROSCOPIC SURGICAL INSTRUMENT
  73. K813019PERCUTANEOUS INTRODUCER: SELDINGER STYLE
  74. K061347VITEK 2 GRAM POSITIVE VRSA SCREEN
  75. K896988NIIC LASER SYSTEM
  76. K872831BIOTROL ALPHA AMYLASE
  77. K081328PATHWAY PV ATHERECTOMY SYSTEM
  78. K060988TOTAL AND HEMI SHOULDER SYSTEM
  79. K833423VENTREZYME EIA CONTROLS-IMMUNOASSAY
  80. K163695Borrelia B31 ViraChip IgM Test Kit
  81. K790876LABELED HUMAN CHORIONIC GONADOTROPHIN
  82. K862482STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS
  83. K930617OBGRIP AND UNITIPS(TM)
  84. K113181CELLTRACKS ANALYER II
  85. K895855PHOENIX
  86. K081335TENACORE OXYGEN BLENDER, MODEL TB-2000
  87. K021450CLINPRO PROPHY POWDER
  88. K852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
  89. K103313HEPARIN ASSAY CONTROLS
  90. K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components
  91. K934056TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3
  92. K004001MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
  93. K852312#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
  94. K140165MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE…
  95. K072950CYGNUS 12 LEAD ECG MODULE
  96. K945538STAPHAUREX PLUS(TM)
  97. K001043KAWASUMI LABORATORY BLOOD DRAWING KIT
  98. K172412BacterioScan 216Dx System
  99. K033489AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM…
  100. K770792TUBE, STAIN, RETICULOCYTE, LARC
  101. K142103CUFF PILOT, SURE SEAL
  102. K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
  103. K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
  104. K924160HYBRID SURGICAL DEVICE
  105. K971618ALCON CONTACT LENS CASE
  106. K961358ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
  107. K181820Medline Unite Mini Plates and Screws
  108. K854577PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
  109. K132455U-MOTION II PS+ CUP
  110. K953461CPR MASK & RELATED FAMILY KITS
  111. K052224BD PROBE TEC URINE PRESERVATIVE TRANSPORT
  112. K905721OPUS GENTAMICIN
  113. K831320DRIONIC
  114. K041938MAXIMUS OS (OVERDENTURE SYSTEM)
  115. K130560MASTERTORQUE LUX 8900 L
  116. K053413TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
  117. K133432SHERPA PAK CARDIAC TRANSPORT SYSTEM
  118. K914272KOKO SPIROMETER
  119. K012122VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
  120. K192168Idys ALIF ZP 3DTi
  121. K040726VENTLAB NASAL CPAP CANNULA
  122. K855124CONVEX PROBE, PVE-382M
  123. K813347CRITIKON TRANSCUTANEOUS GAS MONITORS
  124. K950751TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
  125. K900767B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE
  126. K861723(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
  127. K861271SUCROSEP HUMAN PROLACTIN (HPR) IRMA
  128. K914913GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST
  129. K203784PreXion3D Explorer PRO
  130. K852176DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
  131. K852527SATALEC SEPTOSONIC SC 80/SC 120
  132. K972979SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND…
  133. K192192VSP System
  134. K242985CollOvine™ Wound Dressing
  135. K944702PROCERA ALL-CERAMIC PORCELAIN
  136. K851191ELECTRO-NERVE STIMULATOR DISCO B9 TENS
  137. K122069STORM MINI SCREW
  138. K113720RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
  139. K954699BRAY RONGEUR
  140. K981274ACROMED TIMX PLATE BASED LOW BACK SYSTEM
  141. K883960GIPHY MONITOR
  142. K923013ACOUSTIC APPRAISE CD-3
  143. K946276QUICKVUE(R) CHLAMYDIA TEST
  144. K964050FIRST MIDCATH CATHETER
  145. K050814ATRIUM ICAST COVERED STENT
  146. K012778VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE…
  147. K081861HOLTER LX ANALYSIS
  148. K926438ACTION MEDTEK FACE SHIELD
  149. K790021SERUM, INORGANIC PHOSPHOROUS
  150. K120543TANDEMHEART FEMORAL ARTERIAL CANNULA SET
  151. K010965A-LINE AEP MONITOR
  152. K885261ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS
  153. K850019OMNI PHASE PENILE PROSTHESIS
  154. K163037Intra medullary endo-transilluminating device (iMET device)
  155. K880569TEAMMATE(TM)
  156. K000432RESPONSE 2000 CEMENTED HIP STEM
  157. K993755EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
  158. K962544MICRO DIAMOND-POINT DISSECTION NEEDLES
  159. K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…
  160. K091160LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
  161. K021447TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
  162. K970249SIMPLEX AIRBRATOR
  163. K203529VASSALLO GT Hybrid
  164. K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
  165. K031799MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
  166. K904509POWER TRAINER WITH NEUROMUSCULAR STIMULATION
  167. K071532ALPHA INFUSION PUMP, MODEL A200, A450
  168. K926054ELD-ARONDAK CHAIR
  169. K073214DUOWEDGE SYNTHETIC BONE SUBSTITUTE
  170. K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…
  171. K904101COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
  172. K083723A6 LUER ACCESS DEVICE
  173. K122476LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
  174. K823093CHANNEL BACK
  175. K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK…
  176. K871633TRU-SOUND ULTRASOUND THERAPY UNIT
  177. K011958CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
  178. K010851HARRISON HAND HELD ADJUSTING INSTRUMENT
  179. K122042CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
  180. K912102ACS LIQUID THROMBOPLASTIN
  181. K811006SOLUTION ADMINISTRATION SET
  182. K843254DK*300 VOLUMETRIC INFUSION CONTROLLER
  183. K140080ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC…
  184. K001886APEX FIXATION PINS
  185. K770302CUTTER, P606 BONE
  186. K800458ORTHODONTICARTIDE
  187. K913589EARSCAN DSP-1 PURE TONE AUDIOMETER
  188. K033918EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
  189. K241490Contour+ (MVision AI Segmentation)
  190. K822228GASTRO VAGE SET FOR GASTRIC LAVAGE
  191. K802039PHENOBARBITAL REAGENT TEST KIT
  192. K062336OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
  193. K844103CARDIOPAC DEFIBRILLATOR 444
  194. K770392MUFFLER, AIR PUMP
  195. K951329IMMUCHEM GAL-MW EA
  196. K945144SPONGE COUNT
  197. K850494OHMEDA BIOX 3700 PULSE OXIMETER
  198. K923033THE TRACKER
  199. K874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS
  200. K952281ACTIVE FREE TESTOSTERONE RIA
  201. K051623ANATOMICAL SHOULDER KEELED GLENOID
  202. K930496GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
  203. K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% /…
  204. K830574RENATRON DIALYZER REPROCESSING SYS
  205. K923176SURGICAL INSTRUMENT KIT, DISPOSABLE
  206. K830898SYRINGE 500BC BE #7000
  207. K200549Lucero Medical Cervical Cage System
  208. K032880SUMMIT STAIRWAY LIFT
  209. K913556IVALON EMBOLIZATION PARTICLES
  210. K960482K-WIRE
  211. K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
  212. K033972SCORPIO TOTAL KNEE SYSTEM
  213. K061871LEICA MODEL FL800
  214. K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
  215. K843153ANTERIOR ALVEOLAR RIDGE SIZER
  216. K091942POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES
  217. K890519LABSONICS MAMM-O-MATE MODEL NO. 918084-1
  218. K193144T-Line Hernia Mesh
  219. K123903BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
  220. K943702AVL 988-4 ELECTROLYTE ANALYZER
  221. K141398PASS LP SPINAL SYSTEM
  222. K802162CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
  223. K090659ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART…
  224. K091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
  225. K070508BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
  226. K200810IPS CaseDesigner
  227. K261562Diode Laser Therapy System
  228. K083922MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
  229. K761188HOUVA-LITE PALM UNIT #501
  230. K231032AMP by Method Mobility, AMP Plus (or +) by Method Mobility
  231. K181338Imboki Knee Instrument System
  232. K181890Brainlab Compatible K2M Navigation Instruments
  233. K222146Disposable Endoscopic Hemoclip
  234. K822124TITAN GEL CPK ISOENZYME SYSTEM
  235. K920376COROMETRICS MODEL 150 FETAL MONITOR
  236. K894525FPR PHENOBARBITAL KIT
  237. K040568POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
  238. K111328POWDER FREE NITRILE EXAMINATION GLOVES
  239. K903471BEST LABS MODEL P
  240. K221817ALFIS Vitamin D, ALFIS-3 Analyzer
  241. K150912Houva-NET Control System
  242. K821874ULTRACHEM PHOS
  243. K994016PHARMASEED, MODEL BT-103-3
  244. K822361DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
  245. K221811Vista BC Sealer
  246. K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
  247. K222568OptiCross™ 18 Peripheral Imaging Catheter
  248. K831739PENTOBARBITAL TOXICOLOGY CONTROL
  249. K936002CINEMAC QAS
  250. K081731DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI…
  251. K810080VASCULAR TIE (VAS-TIE)
  252. K091133APLION TOPICAL CARE SYSTEM
  253. K172973Life Spine Foot and Ankle Plating System
  254. K854346MEDIFLEX DISPOSABLE TUBING CLAMP
  255. K905463GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION
  256. K852483SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
  257. K841601TERUMO SENSIBEAD THYROXINE EIA KIT
  258. K172662reVive Perioral
  259. K800882ANTICONVULSANTS TOXICOLOGY CONTROL
  260. K201090Structur CAD
  261. K962574WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
  262. K960357DSL ACTIVE I-HCG IRMA
  263. K083081MODIFICATION TO SECURACATH, MODEL: SPK01
  264. K040951SR ADORO
  265. K9837966004 NIBP MONITOR WITH TEMPERATURE
  266. K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…
  267. K862424STEERABLE CATHETER SYSTEM
  268. K924753BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
  269. K211821DEKA Motus AZ
  270. K950108R-MED MINI-RETRACTOR
  271. K071527PNEUPAC VR1 AIR MIX
  272. K131993MULTICHEM U
  273. K081653MDI MII ONE-PIECE IMPLANT, 2.9MM
  274. K991623NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA…
  275. K982395DYTRACT FLOW RESTORATIVE
  276. K970144VINYL EXAM GLOVE POWERED
  277. K813619CONPHAR-SCHIOETZ TONOMETER
  278. K973351ELECSYS AFP
  279. K915746SIMPLASTIN L
  280. K032734CONVATEC FECAL MANAGEMENT SYSTEM
  281. K033844SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
  282. K851238CHAMBER V-9 PLUS AGAR
  283. K221453S.I.N. Dental Implant System
  284. K113378CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
  285. K080797HUMIDAIRE 2I
  286. K143090LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
  287. K04155955CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL…
  288. K182733Rochal Bioshield Silicone Film
  289. K172943Flex-Thread Fibula Pin System
  290. K083434TT1 GENERAL PURPOSE COIL
  291. K002163MICROSTREAM EXTERNAL BATTERY CHARGER
  292. K172346sterEOS Workstation
  293. K974344CT SCOPE
  294. K260694ZEISS CLINIC 360
  295. BK170059Automated Blood Cell Separators
  296. K895011TRIDENT DRAPE SUPPORT
  297. K883091SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
  298. K023415MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
  299. K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…
  300. K921256LUQUE V SPINAL SYSTEM
  301. K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS…
  302. K850754MEDAJET XL - JET INJECTOR
  303. K780195WHEELCHAIR MUFF
  304. K231896Diode Laser Therapy System
  305. K180426Empower H35
  306. K895838BRACKMANN EMG MONITORING SYSTEM
  307. K162212DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
  308. K972824THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
  309. K140422HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
  310. K071048RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
  311. K821532PERIGUARD PERICARDIAL PATCH
  312. K801995EYE PADS CAT.#581-599
  313. K902287RASTRONICS PORTAREM 20
  314. K252521LifeStyles® HydraFeel Natural Rubber Latex Condom
  315. K140074HYGEDENT ALGINATE IMPRESSION MATERIAL
  316. K770714CATHETER, ARTERIAL EMBOLECTOMY
  317. K790461T-3 UPTAKE (MAA) KIT
  318. K000293BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
  319. K012734CLEARFIL NEW BOND
  320. K955767COFIED MODULAR SHOULDER SYSTEM
  321. K912781ELECTROSHIELD
  322. K052748SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS
  323. K962693MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
  324. K921340FORCE MEASURING PLATFORM
  325. K823561URETHRAL PRESSURE PROFILE & TEMP. MODUL
  326. K021455RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777…
  327. K883086INTERSEPT*PREBYPASS FILTER
  328. K973590HEMORRELIEF DEVICE
  329. K181478Roosin Xeroform Petrolatum Dressing
  330. K942901SHARPS-TAINER LARGE OPENING
  331. K132407VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
  332. K831977C TEC SERIES 9000 E.C.G. ELECTRODE
  333. K102140FETAL MONITORS, MODELS F2 AND F3
  334. K010975ECLIPSE 6.5
  335. K242752MRidium 3870 MRI Infusion Pump System (3870)
  336. K020078EXACTECH RESORBABLE BONE PASTE
  337. K992116SIEMEMNS INFINITY ETC02 POD
  338. K113233POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
  339. K003871LAPAROSCOPIC HAND PORT
  340. K841451BIOTRONIK DY-UNIPOLAR
  341. K011881DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
  342. K915690SLT 340 ATTC
  343. K122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
  344. K882778BASAL MEDIUM EAGEL, CATALOG NO. 200-2044
  345. K895372X-RAY DETECTABLE GAUZE SPONGE
  346. K993159MAXIM KNEE SYSTEM
  347. K895231CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
  348. K932542SCIMED 6F ANGIOGRAPHIC CATHETER
  349. K790625PEPTONE-YEAST EXTRACT BROTH
  350. K993629ABI VEST AIRWAY CLEARANCE SYSTEM
  351. K962969MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA
  352. K930339REAMER BIT
  353. K932456JARIT SURGICAL INSTRUMENTS
  354. K251901Magnifico Open (100009900)
  355. K223107MOLLI 2
  356. K123425TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
  357. K780559DISPOSABLE INFUSION SET
  358. K963623SPYROFLEX PIGMENTED WOUND DRESSING
  359. K110071COR ANALYZER
  360. K031945ARTHREX TRIMIT SCREW, MODEL AR-4161B
  361. K984310MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
  362. K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0
  363. K100143PILOT DIODE LASER, MODEL 002-00139
  364. K841077ARK TONGUE CLEANER
  365. K971852AIR CONDUCTION HAEARING AIDS
  366. K241319SKR 3000
  367. K810818KEY-MED FIBRESCOPE DISINFECTION TROLLEY
  368. K011299SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
  369. K905053STAGE ZERO AIR FLOTATION BED
  370. K782120SPONGE SYSTEM, ROSERING CONTAIN-COUNT
  371. BK200456Blood Establishment Computer Software and Accessories
  372. K211746Pocket Ultrasound System
  373. K083749CARDIOVIEW32 REVIEW MODULE
  374. K031363QCA (VERSION 3.1)
  375. K964948AURORA 52 (PM-01)
  376. K251371Sysmex XR-Series (XR-20) Automated Hematology Analyzer
  377. K871752CSF-CARDIAC/PERITONEAL CATHETER
  378. K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1…
  379. K173072Algidex Ag Silver Alginate Wound Dressing
  380. K833163MEM-EAGLE W/EARLES SALTS W/IVEAA
  381. K873226XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601
  382. K863251URIC ACID PROCEDURE
  383. K210240Air Compression Therapy Device, model HW6007
  384. K123159SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
  385. K212851EchoSK and EchoSGyn modules for EchoS Family devices
  386. K230495Serena Sleep Night Guard
  387. K791478FLUID THIOGLYCOLLATE MEDIUM
  388. K101566VITEK 2 YEAST CASPOFUNGIN
  389. K812556DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
  390. K830875S & W MODEL 29
  391. K242045Initia T3 Acetabular Hemispherical Shell System
  392. K250138Small Volume 0.2mL Syringe
  393. K133148BIOMARC COAXIAL NEEDLE
  394. K173856Express 4 Sleep appliance/CPAP Sidekick appliance
  395. K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
  396. K950346B-L RED(TM) DISCS
  397. K981463OMNITECH RESECTOSCOPE ROLLER ELECTRODE
  398. K221866S-Plant Dental Implant System
  399. K140272SWIFT-LOCK ANCHOR
  400. K201878ST-Z5
  401. K850306CAMPYLOBACTER SUPPLEMENT -SKIRROW
  402. K242387Mobility Scooter (N3473)
  403. K791655CPK ISOENZYME REAGENT
  404. K925628ULTRATUFF CUT RESISTANT GLOVE LINER
  405. K253942Pulmonex II Xenon System (132-503)
  406. K874728CAPILLARY FLOW DIALYZERS
  407. K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye…
  408. BK140144Solution, Stabilized Enzyme
  409. K961204MUMPS IGG TEST
  410. K891240DIRECT BILIRUBIN FOR CONTINUOUS FLOW
  411. K771760EXTEMP
  412. K222587PatCom Distal Chip Endoscope
  413. K252849AffloVest® Mobile Airway Clearance Therapy
  414. K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
  415. K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
  416. K101702MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
  417. K915707AMMONIA REAGENT SET
  418. K243353One-Fil Putty
  419. K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)
  420. K914840DERMAPROOF
  421. K000651DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
  422. K093837ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
  423. K231604Instrument Case
  424. K874008OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)
  425. K251583Ambu® Virobac II® Exhalation Filter
  426. K101876DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
  427. K873260CORYNEBACTERIA ISOLATION MEDIA
  428. K980792CU-100A LIGHT CURE UNIT
  429. K071481HEALIX ANCHOR
  430. K231964Novii+ Wireless Patch System
  431. K091258EXTRAFIX EXTERNAL FIXATION SYSTEM
  432. K140384FMWAND HANDPIECE SE
  433. K130538WINX SLEEP THERAPY SYSTEM
  434. K073593I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR)…
  435. K053158OPTILENE MESH LP
  436. K150747EzDent-i /E2/Prora View
  437. K833237DIGITAL RADIOGRAPHY SYS DUAL GANTRIES
  438. K883104CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
  439. K812633ACA IMMUNOGLOBULIN A/M CALIBRATORS
  440. K760722BIRT-A-CHUCK DISPOSABLE ELECTR. HANDLE
  441. K052929PREFTEST PROFESSIONAL SUITE
  442. K926112ACCUTEX BETA-HCG TEST
  443. K900200COOK STEREOTAXIC GUIDE
  444. K151270CrossTIE Intraosseous Fixation System
  445. K873332MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM
  446. K913700DISPOSABLE BOUFFANT CAP
  447. K837346MODEL GAMMACELL 1000
  448. K800026MICROTHIN-DI
  449. K875109DETECTADOT SYSTEM 2000 TOXO IGG TEST
  450. K203076Mecta-C Stand Alone Extension
  451. K770247D.C. AMPLIFIER MODULE
  452. K091703HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
  453. K954739DERMAGRAN HYDROPHILIC OINTMENT
  454. K203084Ablamap Software
  455. K060879MODEL EC9-4 TRANSDUCER
  456. K102252DMP PIT & FISSURE SEALANT
  457. K000320SONOS AIRES 600 (SA-600)
  458. K882786RPMI-1640 CATALOG NO. 200-2079
  459. K232643Cue COVID-19 Molecular Test
  460. K060772MANUEL SAFTEY SYRINGE PARTS 1 & 2
  461. K893626FLEXMEDICS GUIDEWIRE
  462. K944493REVERSE OSMOSIS SYSTEM
  463. K220962ROTAPRO Rotational Atherectomy System
  464. K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
  465. K233911VISULAS combi
  466. K203694DELTA XTEND Reverse Shoulder System
  467. K052898IQMARK EZ STRESS
  468. K791904IMV W/BAG & HOSES #M-509
  469. K780645HMD-2000 BATTERY-POWERED MINI-DRILL, THE
  470. K150103Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
  471. K945832BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS
  472. K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
  473. K963583MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND…
  474. K891533M-74 GOLD BASE DENTAL ALLOY
  475. K900788MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
  476. K071189CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
  477. K093534MODIFICATION TO CASPIAN SPINAL SYSTEM
  478. K810946ADULT & PEDIATRIC TRACHEOSTOMY MASKS
  479. K860559ANDROSTENEDIONE 125I KIT BY RIA
  480. K935968SPECTACLE FRAMES
  481. K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
  482. K163613Bluephase Style 20i
  483. K020565EAV COMBI-2
  484. K103828BILI-THERAPY SPOT TYPE
  485. K853080WILLIAM HARVEY HYBID OXYGENATOR H-1700
  486. K870663API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC
  487. K080815TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
  488. K882527GAUZE SPONGE
  489. K810895ESOPHAGEAL PILL ELECTRODE
  490. K891680LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
  491. K063443DRAEGER ALCOTEST 6510
  492. K162816SML-OSA2 Appliances
  493. K972797TOOL-LESS WHEEL CHAIR
  494. K981792SOLUTION ADMINISTRATION SET
  495. K083832ZEST NASAL MASK
  496. K063557PEAK BOND, MODEL 5133
  497. K912961MORSE VASCULAR INTRODUCER SET
  498. K060676NES REPROCESSED ENDOSCOPIC TROCAR
  499. K911478LAPAROSCOPIC SNARE POUCH
  500. K854313SONGER TITANIUM SPINE-L-ROD
  501. K933374NITI COIL SPRINGS
  502. K862919TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
  503. K944481THE HEART PROTECTOR
  504. K082826VANGUARD CR STEM HOUSINGS
  505. K172173DiaSpect Tm, DiaSpect Tm Cuvettes
  506. K240910EO Chex Indicator Tape
  507. K771814REAGENT CONFIDENCE SERA
  508. K181200AEROmini Tracheobronchial Stent System
  509. K193145Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
  510. K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath…
  511. K921281TRACHEOSTOMY CARE KIT
  512. K904160CYTOSMEAR BRUSH
  513. K982943TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
  514. K010100AVON PATELLO-FEMORAL JOINT PROSTHESIS
  515. K945247POWDERFREE LATEX EXAMINATION GLOVE
  516. K0620545 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
  517. K771312BLOOD UREA NITROGEN (BUN) REAGENT
  518. K071543HALO360' COAGULATION CATHETER
  519. K931284MICRODYNE OFFICE SURGICAL MICROSCOPE
  520. K934626GOODALL LASER TARGETING DEVICE
  521. K080462PROGENIX DBM PUTTY
  522. K833587DISPOSABLE ARTHROSCOPY BLADE
  523. K910181HITT BY HEMOCHRON(R)
  524. K965017REGIONAL ANESTHESIA TRAYS
  525. K142080NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID…
  526. K130319MEDLINE CANNULATED SCREW
  527. K092032BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
  528. K781148ELECTROSURGICAL PENCIL SYSTEM
  529. K901786LASEGUIDE CAT # CLF-600D & CLF-1000D
  530. K831160LEAD ADAPTERS #'S 6016,6022,6017 ETC
  531. K833349EVENT TAPE RECORDER 8293
  532. K251801Diode laser device (BM091)
  533. K820736CENTRAL VENOUS ACCESS CATHETER
  534. K913041ANTI-DSDNA ANTIBODY TEST
  535. K992925AX WORKSTATION DR-VIEWER SOFTWARE OPTION
  536. K945370C-POST
  537. K093260AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
  538. K231342Insufflator (OPTO-IFL1000)
  539. K091967MEDACTA BIPOLAR HEAD
  540. K855141ANGIOMED FINE NEEDLES AND NEEDLE SET
  541. K980235REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
  542. K902208MODIFIED OVUGEN
  543. K012762MJS POSTERIOR STABILIZED KNEE SYSTEM
  544. K201704CoFix System
  545. K170515Sterile Nitrile Surgical Gloves, Powder-free
  546. K073479KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM
  547. K193474Selectra 3D Outer Guiding Catheters
  548. K242505Elecsys Cortisol III
  549. K863638GUTTA PERCHA POINTS
  550. K993592AXIOM MULTIPURPOSE WOUND DRAIN
  551. K161236Universa Firm Ureteral Stents and Stent Sets
  552. BK210601System, Test, Automated Blood Grouping and Antibody
  553. K925765BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE
  554. K833209ACIDICASE-BB1
  555. K864631MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE.
  556. K000396APNOESCREEN PRO, ALPHA SCREEN PRO
  557. K051224BOSWORTH SEAL
  558. K071671SCANSCOPE XT SYSTEM
  559. K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…
  560. K150188SMV Scientific 4.5 mm Bone Screws
  561. K972799DRIED GRAM-POSITIVE MIC/COMBO PANELS
  562. K233643F&P Airvo 3 NIV (PT311US)
  563. K790223DIALYZER, CD-800 COIL
  564. K150812Genesys Spine Apache Cervical Interbody Fusion System
  565. K132947DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
  566. K873406RRT SHORT RAGWEED TEST KIT
  567. K9507051.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE
  568. K915681CHOLEDOCHOSCOPE
  569. K935973ARGISTAR 72 (HIGH GOLD PLATINUM SILVER ALLOY FOR BOTH LOW FUSING PORCELAIN AND CROWN AND…
  570. K800237FOLDING CRUTCH
  571. K233634TeleScan
  572. K894093SPACELABS MODEL 90900
  573. K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
  574. K231307Elos Accurate Customized Abutment
  575. K052213NAVIGATION SW HIP 3.1 ON CI
  576. K123402DIAGNOCAM
  577. K951977DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
  578. K811117EYE CARE TRAY
  579. K891840VINYL EXAMINATION GLOVES
  580. K780487FETAL MONITORING SYSTEM
  581. K852113ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81
  582. K853147SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY
  583. K143225INFX-8000V with Wireless Footswitch
  584. K961998QUALITROL SYPHSERO CONTROL SET
  585. K040229A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
  586. K180443Tumark Vision
  587. K861137ORTHOMED ORTHOPAEDIC FIXATION STAPLES
  588. K031189UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
  589. K832684SERALYZER TRIGLYCERIDES REAGENT STRIPS
  590. K844169VOLUMATIC
  591. K940431TECNADYNE 20/20 FOG INHIBITOR KIT
  592. K013222SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
  593. K954875ASPECT ACQUISITION MODULE (AAM)
  594. K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…
  595. K884266PH BLOOD GAS CONTROL PRODUCTS
  596. K050321ONTRAK TESTCARD 9
  597. K842636TECHNICON H*1 SYSTEM
  598. K822935THYROID STIMULATING HORMONE
  599. K063020INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM
  600. K951895ACCU-BEAM 300W XENON LIGHT SOURCE
  601. K890591PATIENT EXAMINATION GLOVE
  602. K012745TRIAGE TOX DRUG SCREEN, CATALOG #94000
  603. K822455VASOGRAPH, MODEL MV-2
  604. K192657Sterile High-pressure Angiographic Syringes for Single-use
  605. K871688SPECTACLE FRAME - DANIELLE
  606. K871905TOXOPLASMA GONDII IGG ELISA
  607. K923981IVAC SYRINGE PUMP - 740 SERIES
  608. K103359FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
  609. K153289HEALTHMYNE
  610. K802501V FACTOR DISCS
  611. K122578VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
  612. K033471PHOSPHOLIN ES AND CALCIUM CHLORIDE
  613. K001364BD DIRECTIGEN FLU A+B
  614. K955150MAXI-FLOW
  615. K953987ACS TOURGIDE GUIDING CATHETER
  616. K963664DENTAL HANDPIECE AND ACCESSORY
  617. K133856POWERGLIDE MIDLINE CATHETER
  618. K121543ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
  619. K211996Nexta PEEK Hammertoe Correction System
  620. K851975ENTERAL FEEDING BAG, 1000 ML, & TUBING SET
  621. K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
  622. K123467VS3
  623. K990308ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
  624. K941487INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS
  625. K093784ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
  626. K013987REPROCESSED DISPOSABLE TROCARS
  627. K991351OVOIL-150, MODEL 5002
  628. K882007EXTENDED LIFE INJECTION SITE
  629. K211025Oral/Enteral Syringe with ENFit connector
  630. K062297VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
  631. K844823MICROINFERTILITY FORCEPS, TITANIUM
  632. K153560Optilite Low Level Albumin Kit
  633. K210050Augmented VaultLock Glenoid
  634. K143281Ultimax-i
  635. K921257EURION LOTOS P HEARING AID
  636. K193507Merit ONE Snare System
  637. K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
  638. K960880MILL-ROSE BLIND MICROBIOLOGY BRUSH
  639. K133532ALARIS SYSTEM WITH GUARDRAILS SUITE MX
  640. K992236LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000…
  641. K963241ULTRAFLEX
  642. K964603ARTICULAR HEARING AIDS
  643. K182538Merit RadialFlo Arterial Catheter
  644. BK220746A device indicated for use in a test system to estimate test precision or to detect…
  645. K151034PainKARE
  646. K914617CATHETER, URETERAL DILATOR
  647. K183328Pulse Rx 2.0, Pulse Pro Rx 2.0
  648. K882585CAVROLAB
  649. K063633DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
  650. K942981ARGESOL #585
  651. K880349MODEL 759 CUSTOM IN-THE-EAR HEARING AID
  652. K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…
  653. K834191JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
  654. K832045ACETAMINOPHER ASSAY KIT
  655. K853726LARYNGEAL
  656. K171575ENFLU 18 (enflufocon A) Daily Wear Contact Lens
  657. K202648Biofeedback Nerve and Muscle Stimulator
  658. K915613BONE SCREW 3.5 MM
  659. K230960DLP™ Silicone Coronary Artery Ostial Cannulae
  660. K201431OGYILI TENS/NMES Stimulator
  661. K772099PRINTER
  662. K041038CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
  663. K101233SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
  664. K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
  665. K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
  666. K770081BAND-AID BRAND OF ADHESIVE BANDAGES
  667. K170021SMV Scientific Cannulated Screws
  668. K231418ENDOGATOR™ Hybrid Irrigation Tubing
  669. K862225INTERNATIONAL TOTAL HIP SYSTEM
  670. K830463LIFELINE UNIPOLAR J-LEAD #483-05
  671. K881196AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL
  672. K844341UNITED SKIN BARRIER PASTE
  673. K874447DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC
  674. K962945CORDIS OPTA PTA BALLOON CATHETER
  675. K780511SNAP-FIT
  676. K860583DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
  677. K140406DESTINO TWIST, STEERABLE GUIDING SHEATH
  678. K082981DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
  679. K885314HPD STERILE HUMIDIFYING CHAMBER
  680. K960886STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS
  681. K890121MODIFIED DPX BONE DENSITOMETER
  682. K160245Visco (olifilcon A) soft contact lens
  683. K780826BILIRUBIN RAPID STAT KIT
  684. K230002Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with…
  685. K840010DADE HEMATOLOGY CALIBRATOR PLUS
  686. K943337STANDUP WHEELCHAIR
  687. K951001FLEXICAIR EXLIPSE
  688. K202213syngo.CT Neuro Perfusion
  689. K073445CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
  690. K261663EzSensor HD
  691. K834192JAKOBI SURG. INSTRUMENTS #3 21/22/24
  692. K961117VISARD SUNGLASSES
  693. K050446BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
  694. K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
  695. K822515B-HCG RADIOIMMUNOASSAY KIT
  696. K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus…
  697. K853710THERACUSHION
  698. K922579BARTELS TOXOPLASMA IGM EIA
  699. K891528M-65 GOLD BASE DENTAL ALLOY
  700. K911747PRO-GUIDE
  701. K895431JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
  702. K760970FLORIO CPC BAND
  703. K191411Ah!Yes Ob Coco Personal Lubricant
  704. K222457Provata Implant System
  705. K230372VitreJect Syringe
  706. K790308DISPOSABLE DIALYZERS, SD-ID, SD-2D
  707. BK020004Test, Qualitative, for HLA, Non-Diagnostic
  708. K843961COLOR OPTIC CORNEAL EYE SHIELD
  709. K843023KERR PORCELAIN REPAIR PRIMER
  710. K901247TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
  711. K852622AEROSOL ONE
  712. K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
  713. K900160ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER
  714. K000764PEDIATRIC FIXATION RODS
  715. K800097MINIVASON 9
  716. K171868A1AT Genotyping Test
  717. K871596IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
  718. K890760STRIP, STERILIZATION INDICATOR, E.O. GAS
  719. K953054AM 260 OHM
  720. K240676ULTIMUS Series Ultrasound Diagnostic System
  721. K861401LAERDAL POCKET MASK
  722. K070773AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR
  723. K945213TEEN 100
  724. K083483BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
  725. K123530MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
  726. K791329FLUOROMATIC ANALYZER AND AUTOSAMPLER
  727. K141985TRUE BA V BALLOON VALVULOPLASTY CATHETER
  728. K240435Alpha Dent Implants Dental Implants System
  729. K962314HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
  730. K841994EZY-RAMP
  731. K101018CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
  732. K200024uMR 570
  733. K123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
  734. K871495BANDAGES CATALOG NUMBER: 101 TO 220
  735. K202674Medidenta High Speed Handpieces
  736. K991511POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
  737. K863694BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS
  738. K970699AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
  739. K210636Morpheus
  740. K950164PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
  741. K941390DISPOSABLE ASPIRATION/IRRIGATION TRUMPET VALVE PROBE
  742. K850356PRUITT-VASCULAR SHUNTS
  743. K813572CENTRIA PROLACTIN TEST SET
  744. K820817OPTACRY/95 GRAY CONTACT LENS BLANKS
  745. K944418THE SPACEMAKER AND THE SPACEMAKER II
  746. K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
  747. K071828LULLABY
  748. K242130Koios DS
  749. K1132403.7 MP COLOR LCD MONITOR, RADIFORCE MX270W
  750. K820169MALE LUER CONNECTOR & HINGED CAP
  751. K905459SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM
  752. K190646QT Scanner 2000 Model A
  753. K203654Solevy Co. LLC Water-Based Personal Lubricant
  754. K892085PATIENT EXAMINATION GLOVES (LATEX)
  755. K851350ION 2 REAGENT KI
  756. K902615ADG BONE PLUG
  757. K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
  758. K150958LifePearl Microshperes
  759. K803299COLD/HOT PACK
  760. K810342NASAL CANNULA
  761. K965004C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
  762. K050483EVADRI BLADDER CONTROL SYSTEMS
  763. K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary…
  764. K961628MINI FLEX COIL
  765. K834604C3 ANTISERUM CONTROL
  766. K113673MYSAFETY SYRINGE
  767. K791519LEVINE EMB AGAR
  768. K050301MRIDIUM 3850 MRI PUMP SYSTEM
  769. K844409DTL ELECTRODE
  770. K203525D function
  771. K063274ACCULOC BREAST LOCALIZATION SYSTEM
  772. K192072Tina-quant C-Reactive Protein IV
  773. K801443P-S SUCTION RESERVOIR
  774. K842741GILL HEMATOXYLIN STAIN
  775. K990035RF
  776. K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
  777. K844495MEDIPART XENON BREATHING KIT MP-02XM
  778. K022127AVAGEN WOUND DRESSING
  779. K864074ELASTIC STAIN
  780. K844074HOBBS MEDICAL POLYPECTOMY SNARE
  781. K781233IV ARMBOARDS
  782. K170817Halcyon
  783. K974887POWDERFREE GREEN NITRILE EXAMINATION GLOVES
  784. K951776BAND SEATER
  785. K112053OBC BONE ANCHORED HEARING SYSTEM
  786. K071181DIRECT DIGITIZER, REGIUS MODEL 110
  787. K123764DURETTE OCULAR IMPLANT
  788. K151869Microlife Upper Arm Automatic Digital Blood Pressure Monitor
  789. K931379MICROVASIVE INSURG LAPTIE SUTURE LIGATOR
  790. K924002MIDLAND THREE SECTION P.T. TABLE W/ DRAINAGE
  791. K942462ARGESOL-YSF PRE-SOLDER FOR HI GOLD DENT PORCEL ALLOYS
  792. K934664HYDRAGOWN
  793. K800350ENDOCARD. PACING LEAD STD. LENGTH PL202
  794. K190157Diana ChemoClave Transfer Set
  795. K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
  796. K933104ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG
  797. K970895CUSTOM OPTICAL SUNGLASS FRAMES
  798. K781623PACING MODELS MUM 860, MUM 890
  799. K862609INTERFACE ARTERIAL BLOOD FILTER, MODEL 44
  800. K093817GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
  801. K172044Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent…
  802. K960255CERAMIC BLADE ELECTRODE
  803. K895723IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
  804. K233381DRX-Evolution Plus System
  805. K981805POS T-7000
  806. K130099TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
  807. K781584GRAM STAIN KIT
  808. K981218CREATINE KINASE (CK)
  809. K871921GENERAL PURPOSE COMBINATION PH ELECTRODE
  810. K011587SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
  811. K882712STICK SPONGE
  812. K073241VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
  813. K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
  814. K834610LASER LENS-VARIOUS MODELS
  815. K012202NUMARIS 4VA15A
  816. K060743MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE…
  817. K77195812MM SELF-SEALING TROCAR & CANNULA
  818. K002639BIOKNOTLESS ANCHOR
  819. K212279Digital Intraoral X-ray Imaging System
  820. K925215STERILE SURGICAL INSTRUMENT TRAYS
  821. K250108OptiVu™ Shoulder
  822. K042673ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
  823. K140879BIOSURE HEALICOIL PK INTERFERENCE SCREW
  824. K912702PLASTIC ATTACHABLE DUAL PORT
  825. K854324PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
  826. K222727i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
  827. K080151ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
  828. K151839AMC Health VitalCaregiving System
  829. K13318121.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
  830. K091075ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
  831. K142638ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
  832. K950629ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA…
  833. K870947DYNATRON 500
  834. K780626VENTURI OXYGEN MASK
  835. K023250LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE
  836. K102226DUAL INCU I
  837. K964640CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND…
  838. K131166SOFIA(R) HCG FIA
  839. K965045TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
  840. K812176KORICLEAN
  841. K821034SKATRON REPEATING DISPENSER
  842. K913123EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
  843. K865032CARDIOFAX-V ECG-834OA
  844. K013286CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE…
  845. K772333RECORDER, PAPER, ECG
  846. K942495SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
  847. K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…
  848. K930803ACTION PATRIOT MANUAL WHEELCHAIR
  849. K060243OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
  850. K131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR…
  851. K171577Smartcord, Smartcord X
  852. K182078MiniCollect K2E K2EDTA Tubes
  853. K781860ASSAY, CHROMOGENIC ANTITHROMBIN III
  854. K161984Interlocked Circular Small Field Collimators, Elekta Integrated
  855. K833849ACTH RIA
  856. K871852COXA ACETABULAR CUP
  857. K261465INDIRA CLOUD VIEWER
  858. K922442ISOLATION GOWNS
  859. K955904EKTACHEM DT LDL CHOLESTEROL KIT
  860. K882282SUIT, SURGICAL
  861. K990974VITOP DRESSING
  862. K211314OCS Lung Solution
  863. K010025ELECTRICATOR MODEL 26000
  864. K024056SURESET 3.0 ML RESERVOIR, MODEL 24-103
  865. K854064BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
  866. K853564LIFEPAK 200
  867. K261580ZBPro Diagnostic (Version 2.0)
  868. K945389IVR MASTER
  869. K091279NIPRO DISPOSABLE SYRINGE
  870. K081110SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
  871. K952581GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
  872. K911482LAPAROSCOPIC SNARE
  873. K981155FLAPMAKER DISPOSABLE MICROKERATOME
  874. K082991BIOLOX DELTA CERAMIC FEMORAL HEAD
  875. K083649CARDIUS 3 X-ACT
  876. K192110Vitek Densichek
  877. K941498BIOMEK SL WITH BIOMEK SL INCUBATOR
  878. K181510ECHOLASER X4
  879. K926127SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM
  880. K100075POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
  881. K232204ReyaGel (RG03 - MTP gel 3mL)
  882. K942179PRO-TEC DISPOSABLE SHARPS CONTAINERS
  883. K873335WAKO(TM) AUTOKIT UREA N
  884. K884965BACTIGEN(R) MENINGITIDIS PANEL
  885. K912189LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION
  886. K170163Erisma® LP Spinal Fixation System
  887. K001755MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
  888. K232543MSC SFM
  889. K811815UROPAPER EIKEG
  890. K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)
  891. K910272HGM COMBINATION ND:YAG & SOLID STATE GREEN
  892. K863304PRESELECTED FLOW RATE I.V. SET
  893. K9814150-20 CM H20 PEEP VALVE
  894. K951352DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE
  895. K891050STAT CHEM SYSTEM
  896. K850017PRECINORM H & PRECIPATH H
  897. K081849BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
  898. K882748NORMOCAP 200 CAPNOMETER
  899. K903007MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
  900. K771832CHLORIDE
  901. K080765CROSSER LP SYSTEM
  902. K212971NPseal
  903. K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
  904. K181497HPM-6000UF
  905. K843565KOVA TROL I,II, III HUMAN URINE-DRIED
  906. K031022PROTEC-TOP, STERIDENT, BENTO
  907. K022626MOISTURESTAY (REVLON)
  908. K953497COMFEEL:ALGINATE DRESSING
  909. K923091KING DIAGNOSTICS GAMMA GT REAGENT
  910. K161601Dynamika
  911. K981576MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
  912. K121372FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
  913. K202132Venue
  914. K042911CEMENTEK LV
  915. K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANT
  916. K893709COHERENT MARIE ARGON PHOTOCOAGULATOR
  917. K232293kallisio stentra™ oral stent
  918. K915352LASER FIBEROPTIC DELIVERY SYSTEM
  919. K091635VENUS DIAMOND FLOW
  920. K993873ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
  921. K000131QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
  922. K111122AESCULAP SIBD XP SPINAL SYSTEM
  923. K170903Compex Wireless USA
  924. K200095Streamline Navigated Instruments
  925. K842835BRILLETTE MODEL
  926. K260512Disposable Ureteral Access Sheath
  927. K851922URETERAL STONE DISLODGER
  928. K023687SOMATOM EMOTION 6 CT SYSTEMS
  929. K060387PHYSIOFLOW SYSTEM
  930. K894515LISS CRANIAL STIMULATOR MODEL SBL201-M
  931. K883713QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
  932. K780134URINARY DRAINAGE MONITORING SYSTEM
  933. K161025priti multidisc ZrO2 High Translucent
  934. K861666BLOOD UREA NITROGEN (BUN) PROCEDURE
  935. K020343SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL
  936. K896076L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
  937. K15033118ch T/R Knee Coil
  938. K925156OLYMPUS ALKALINE PHOSPHATASE REAGENT
  939. K042057INFINITY ELECTROTHERAPY SYSTEM
  940. K200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
  941. BK110011Test, Qualitative, for HLA, Non-Diagnostic
  942. K924217LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
  943. K090618CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
  944. K942731SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
  945. K896155RED DOT CARDIAC SENSOR SYSTEM
  946. K073618VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
  947. K162533Kelowna GYN and Crook Prostate Templates
  948. K970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
  949. K781218ANEMOMETER, NASAL, EXETER
  950. K003496CANNULATED SCREW SYSTEM
  951. K895596FORTRESS 1000FS ADD-ON POWER UNIT
  952. K113666XIA 3 SPINAL SYSTEM
  953. K960928SYRINGEFILTER
  954. K894962CO2 LASER BRONCHOSCOPE COUPLER
  955. K000125JET PORT PLUS CATHETER SYSTEM
  956. K843044MINIM. ESSENTIAL MED. EAGLE M4144 W/
  957. K863016DENTATUS L SET
  958. K092591ORTHOPANTOMOGRAPH OP30
  959. K974232ESSENTIAL SHAVER SYSTEM
  960. K083191DETLOGIX ANNULOPLASTY RING, MODEL: 5100
  961. K942599WARM AIR WARMING UNIT
  962. K11158115 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15…
  963. K942588NON-PRESCRIPTION SUNGLASSES
  964. K061438ULTRAEZ DESENSITIZING GEL
  965. BK120039Blood Establishment Computer Software and Accessories
  966. K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
  967. K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
  968. K910971Z XT RADIATION THERAPY TREATMENT TABLE
  969. BK060023Automated Blood Cell Separators
  970. K8370972D CARDIAC SECTOR SCANNER
  971. K943468LEKSELL SURGIPLAN
  972. K760457SCHAEDLER-SELECTIVE AGAR CNA
  973. K113737SUREFIRE GUIDE SHEATH
  974. K821168DISPOSABLE URINARY LEGBAG W/STRAP
  975. K003226THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
  976. K800170AMES RIALYZE - UPTAKE CHROM. TUBES
  977. K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…
  978. K853778THE DEXTRA PRECISION POWER UNIT
  979. K760295CARPET COVERS FOR FOOTRESTS, BK-6467
  980. K042636BIOPLUS
  981. K200035Ultravision Visual Field Clearing System
  982. K981348SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
  983. K964660PARAMAX CHOLESTEROL REAGENT
  984. K982317VECTRA COMBO
  985. K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
  986. K222504H1
  987. K830988OXYGEN CONNECTING TUBE
  988. K822441UNIMETER 330K
  989. K800865WINDSOR
  990. K121197BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
  991. K230444Talee, Talee PostOp
  992. K990547PILLING WECK SURGICAL Y STENT FORCEPS
  993. K062412CRYOMATIC
  994. K152651AccuLIF TL and PL Cage
  995. K832299VISI-FLOW IRRIGATOR
  996. K162113Powder Free Nitrile Examination Gloves (Blue)
  997. K182602SOFIA EX Intracranial Support Catheter
  998. K123633TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
  999. K964521DEPUY DUPONT PHANTOM SUTURE ANCHOR
  1000. K060007BD AUTOSHIELD PEN NEEDLE

About this dataset

A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database