Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K973325BACT/ALERT FAN CULTURE BOTTLES
  2. K963988INTRAVASCULAR INFUSION DEVICE
  3. K042118ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
  4. K772062NEONATAL FLOTATION SYSTEM
  5. K951872STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM
  6. K233859BASIS FLOW II
  7. K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
  8. K875114HOSKINS-BARKAN GONIOTOMY LENS 9MM
  9. K923166VIDAS TOXOPLASMA GONDII IGM ASSSAY
  10. K934668ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)
  11. K896359AG-820PA FI02 MODULE
  12. K092258RANDOX METABOLITE (EDDP) ASSAY
  13. K031869SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
  14. K023561ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
  15. K874891FLEXIE THE COPPER SHANK NEEDLE
  16. K0824534CIS SOLAR AND APOLLON SPINE SYSTEMS
  17. K854775EMPI MODEL 730 NMS
  18. K801482HYDRON ROOT CANAL FILLING MATERIAL
  19. K073683VERIFY CHALLENGE PACKS - VERSION 2
  20. K950694COMPACT-X
  21. K896730SUCTION CATHETER STRAIGHT/COUDE
  22. K092851MODEL GDCH-2000
  23. K102838PATIENT EXAMINATION GLOVES
  24. K821890CRITIKON #817 ESOPHAGEAL MULTI-PROBE
  25. K093494LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
  26. K971489RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
  27. K913040RIBBOND(TM)
  28. K982244MAYFIELD ACCISS OPTICAL SYSTEM
  29. K800086RMS 111F RESPIRATORY MONITORING SYSTEM
  30. K953599CLAMP ASSEMBLY
  31. K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…
  32. K840258TEC-3500 DEFIBRILLATOR
  33. K212386AngioVac F18 85
  34. K9513085.8MM DIAMETER ANCHOR SCREW
  35. K874888ISOLATION GOWN
  36. K233402Bard 3DMax Mesh
  37. K873674SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
  38. K983069PHILIPS DUO DIAGNOST
  39. K160891Ultrathane Endoureterotomy Stent Set
  40. K250146SofWave System
  41. K871861IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
  42. K182688SKR 3000
  43. K011727TRANSSEPTAL NEEDLE/TROCAR
  44. K850524HBSS-HANKS' BALANCED SALT SOLUTION
  45. K910515FREEDOM MARK III SURGICAL HELMET SYSTEM
  46. K842684DIATROL BLOOD GLUCOSE TEST SYS
  47. K830175STERILE COTTON ROLLS #3, 1 1/2
  48. K940410NEW GEAR RELEASABLE HEADGEAR
  49. K844718MODEL 1001
  50. K181805UV Phototherapy
  51. K180293Retia 2
  52. K864477FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000
  53. K221230TRON
  54. K832252CLIRANS TAF06 HOLLOW FIBER DIALYZER
  55. K871766TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
  56. K003522SALUTE
  57. K851040CONCEPT DEFRERE ELECTRODE
  58. K131508VYSIS D7S486/CEP 7 FISH PROBE KIT
  59. K953812GAUZE SPONGE
  60. K945493OPHTHALMIC CAUTERY
  61. K934526MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY
  62. K162510Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
  63. K782016SPIROCARE 108-B
  64. K232363Viz HDS, Viz Volume Plus, Viz ICH+
  65. K210466Silver Gelling Fiber Dressing
  66. K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…
  67. K032050PERIVAC KIT
  68. K162027TRAcelet Compression Device
  69. K102485RE-TRACE URETERAL ACCESS SHEATH
  70. K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
  71. K253849Electric wheelchair (JJW-7002, JJW-7003)
  72. K913002BACTIDROP(TM) FERRIC CHLORIDE (10%)
  73. K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker…
  74. K930587SURGILENE POLYPROPYLENE SUTURE
  75. K091828SHEATHESISO ULTRASOUND TRANSDUCER COVER
  76. K013295TIMX SPINAL SYSTEMS
  77. K822305ORTHO-LEVEL
  78. K893762PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT
  79. K202918OsteoSync™ Ti Dental Mesh
  80. K122625GETINGE 800HC- SERIES STEAM STERILIZER
  81. BK950039Container, Empty, For the Collection '& Processing of Blood/Blood Components
  82. K941342PAIN DOC
  83. K131548SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
  84. K053477MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
  85. K212810MONOFIX PGCL, knotless wound closure device
  86. K083461IMAGINE TC SKIN THERAPY SYSTEM
  87. K922862CHARNLEY TYPE HIP PROTHESIS
  88. K991262<GEN>SINGLE LUMEN NEEDLE
  89. K890383HYSTERECTOMY FORCEPS
  90. K022718VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
  91. K860892CLINAGEL (ABSORBENT GEL)
  92. K031487MODEL AVANT 2120 PULSE OXIMETER AND NIBP
  93. K770642SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE
  94. K8517461-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.
  95. K913067DGH-4000 A-SCAN/PACHYMETER
  96. K921809COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
  97. K983348DYNAREX TRACHEOSTOMY SPONGE
  98. K173448CliniCloud Stethoscope
  99. K042144NICOM
  100. K941968VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC
  101. K261335VitalFlow Set with Balance™ Biosurface
  102. K223866Carevix™ Suction Cervical Stabilizer
  103. K934969DUALGARD FACE SHIELD
  104. K200727TENS and Muscle Stimulator
  105. K903127SURGITEK(R) TURP MONITOR
  106. K924887P54-0 BEHIND THE EAR HEARING AID
  107. K201456Scan Monitor
  108. K812992SURGICAL MASK
  109. K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
  110. K261631Amplatzer TorqVue Exchange System
  111. K990453NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
  112. K844298ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM
  113. K092455MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
  114. K091292BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
  115. K954717SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
  116. K931734INTERMEDICS ORTHOPEDICS DRILL BITS
  117. K840834CORNEAL LIGHT SHIELD
  118. K864902MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.
  119. K130803UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
  120. K934576SUNGLASSES
  121. K963808CHOICE POWERED WHEELCHAIR
  122. K053460MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200…
  123. K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
  124. K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12…
  125. BK120041Automated Blood Cell Separators
  126. K981350ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES
  127. K770271CHEMSTRIP G
  128. K171534SurgicalPreview
  129. K990019DRG MEDIUM SCREW SYSTEM
  130. K0220093I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS
  131. K902588BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD
  132. K111006CI-SNAP WOUND CARE SYSTEM
  133. K251224Restrata Soft Tissue Reinforcement (STR)
  134. K912244UROTEST GPH
  135. K972196OSTEO ANATOMICAL BONE PLATES
  136. K890840VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
  137. K821210SERUM TOTAL PROTEIN REAGENT SET
  138. K043478POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
  139. K0108193CC NMT SAFETY SYRINGE
  140. K812532TEMP-FILL
  141. K010194COMFOR-CLINER
  142. K926529Z CLAMP SCISSORS
  143. K952821MWCHAC 95 FS 12345
  144. K896407HAEMOTRONIC BLOOD LINE SET
  145. K925970MODEL 3D3 OSMOMETER
  146. K083303LANDLEX, MODEL: 402X
  147. K964786ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
  148. K132754NEOGEN PSR SYSTEM
  149. K213127ReNew Disposable Scissor Tips
  150. K110450AGILIS NXT STEERABLE INTRODUCER
  151. K240418Stryker Orthopaedics Hip Systems Labeling Update
  152. K070657GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
  153. K920430MODULAR ACETABULAR CUP SYSTEM
  154. K102373CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
  155. K974047ACCUWELL PHENYLALANINE ASSAY
  156. K031002SYNCHRON SYSTEMS OPIATE REAGENT
  157. K223184Phantom Metatarsal Shortening System
  158. K984097DC-CORE
  159. K791041HEMATRAK ABNORMAL RECOGNITION
  160. K974205KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
  161. K803046IMMU-TRACE T4 RIA PROCEDURE
  162. K112682METHA HIP SYSTEM
  163. K010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
  164. K223876SMR Shoulder System
  165. K850486GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
  166. K163608HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm…
  167. K811043BISMUTH SULFITE AGAR
  168. K926412MICRON-SCOPE II
  169. K151214ALIF Interfixated System
  170. K923245TRIGUIDE-PLUS GUIDING CATHETER
  171. K110304APEX ER. YAG / IPL SYSTEM
  172. K060926TRIPOD
  173. K241919Innovita HCG Pregnancy Rapid Combo Test
  174. K952086TROPICAIR CONVECTIVE WARMING BLANKETS
  175. K003367ORION PLATINUM
  176. K885022MAGNESIUM TEST ITEM NUMBER: SR1019
  177. K931031VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
  178. K131038NMI PICC MAXIMAL BARRIER NURSING KITS
  179. K935878GLASSER SUTURE NEEDLE
  180. K855178DIATRON BLOOD GLUCOSE METER
  181. K831074OSCAR COLOR VISION TESTER
  182. K051568CADD-MS 3 AMBULATORY INFUSION PUMP
  183. K903462OPTIMED GLAUCOMA PRESSURE REGULATOR
  184. K203387AlignRT Plus
  185. K923219URESIL SPECIMEN RETRIEVAL BAG
  186. K063836RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND…
  187. K963906PATIENT RESTRAINTS
  188. K060266DIMENSION IRON CALIBRATOR
  189. K853737VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
  190. K881552PROTEOSE NO. 3 AGAR
  191. K801904SYRINGE INFUSION PUMP #2716
  192. K830401UNILITH PULSE GENERATOR VVI #7542
  193. K951784PRIMALLOR 1
  194. K994389COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
  195. K962000FLEXLENS(METHAFILCON A)
  196. K895262NORMAL COAGULATION CONTROL PLASMA (NCCP)
  197. K833648OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S
  198. K050103XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
  199. K222129Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and…
  200. K922456K6-I DIAGNOSTIC SYSTEM
  201. K883388DENTREK BRIDGE BARS
  202. K883839ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
  203. BK100066Platelet And Plasma Separator For Bone Graft Handling
  204. K161797Avance Tubing, Avance Y-Connector, Avance ViewPad
  205. K010814EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
  206. K828053ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER
  207. K223402HemosIL von Willebrand Factor Antigen
  208. K951080SUNGLASSES
  209. K102191TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY…
  210. K201225Neodent Implant System - GM Helix Implants 7.0
  211. K800773DIGOCTK 125
  212. K842170EMPTY SOLUTION TRANSFER CONTAINER
  213. K171446Cefaly Acute
  214. K222423Fixone All Suture Anchor
  215. K844538COOKED MEAT MEDIUM
  216. K023360LEFORTE SYSTEM BONE PLATE
  217. K860758VACO SUCTION ELECTRODE UNIT
  218. K111740AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
  219. K925739HIGH SPEED DENTAL DRILL/HANDPIECE
  220. K884168ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
  221. K953261CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
  222. K112333LRT ATTACHMENT
  223. K023971VACUETTE TRACE ELEMENTS TUBES
  224. K791999(125I) TESTOSTERONE KIT
  225. K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…
  226. K953962FORCEPS
  227. K033063MISSION CONTROLS
  228. K853950ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
  229. K840906HEARING AID AUDIO-STARR A
  230. K801196LIBCO SUNGLASSES
  231. K875209ACID PHOSPHATASE (KINETIC) CAT. # 320-06
  232. K905012STERILE SURGICAL GLOVES/DOUBLE GLOVER
  233. K914909IL TEST(TM) CALIBRATION SET SP
  234. K843059ATAC 2000
  235. K002240RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
  236. K111997IMAGE1 GI CCU MODEL 22203020-114
  237. K842351STERILE DESIGN-CUSTOM STERILE IV KIT
  238. K043581DUAL LUMEN CATHETER
  239. K990129TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
  240. K162257P1145 Dental Restorative
  241. K915124UNIVERSAL COMPRESION SCREW
  242. K882711GAUZE SPONGE 12PLY
  243. K122161SJM CONFIRM
  244. K171359Pollogen Legend+ System
  245. K810451REUSEABLE HOT & COLD PACKS
  246. K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…
  247. K122388SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
  248. K811673TOTAL PROTEIN TEST
  249. K791443TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE
  250. BK830023Supplies, Blood-Bank
  251. K121953HEMASORB APPLY
  252. K160850Nucleoss Tpure Implant System
  253. K801306CLINETICS PCA COLUMN
  254. K112014ZYSTON STRAIGHT SPACER SYSTEM
  255. K844671CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON
  256. K061712SPIROBANK II
  257. K923083TOTAL BILIRUBIN CATALOG NO. 65407
  258. K261949NYES Tuff Cuff L3 Disposable Gowns
  259. K092609SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
  260. K854943OMKNEE SYSTEM, POROUS COATED
  261. K063034AIR-FLEX WITH AUTO-DISTRACTION
  262. K041936BIOPRO SUBTALAR IMPLANT
  263. K852640MONOJECT STERILE 35CC SYRINGES
  264. K980986PROCAD
  265. K800916P1 BLOOD GROUP SUBSTANCE
  266. K915653KERAMAIL
  267. K853169GT HIP PROSTHESIS FEMORAL COMPONENT
  268. K251843Erchonia EVRL
  269. K933976MANDELKORN SUTURE LYSIS LENS
  270. K062091POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
  271. K875289SUCTION RETRACTOR
  272. K163469ViziShot 2 FLEX
  273. K781674MACRO-VUE TEST, GENTAMICIN
  274. K112439SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
  275. K803064ZIMMER ELECTRICAL MUSCLE STIMULATOR
  276. K200223PocketDoc™ Micro Wound Therapy System
  277. K153463CD HORIZON Spinal System, IPC POWEREASE System
  278. K992901GYNECARE VERSAPOINT G-VAP ELECTRODE
  279. BK820010Device, Warming, Blood and Plasma
  280. K033478VACUETTE QUICKSHIELD SAFETY TUBE HOLDER
  281. K840332CAMPYLOBACTER AGAR BASE
  282. K231886SURGIVISIO Device
  283. BK140164Blood Establishment Computer Software and Accessories
  284. K033597ATR 5000, LC 5000, IMPLANT SYSTEM
  285. K240759REMEX-GR100
  286. K910031PARK CITY SHOULDER POSITIONER
  287. K943949POLYVIOLENE SURGICL SUTURE
  288. K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm)…
  289. K900558PERTAC BOND
  290. K072195THROMCAT THROMBECTOMY CATHETER SYSTEM
  291. K103173VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
  292. K051284MD TURBO
  293. K890173INTERSPEC APOGEE
  294. K865060I.V. SET WITH DUAL-CHANNEL CASSETTE
  295. K832966FLEXIFLO ENTERAL FEEDING TUBE
  296. K060912MODIFICATION TO: HI-ART SYSTEM
  297. K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…
  298. K051088MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
  299. K842478PROLACTIN IRMA
  300. K001277TRIFLANGE ACETABULAR CUP SYSTEM
  301. K080052STRYKER ESSX WITH NAVIGATION MOUNT
  302. K053482SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
  303. K911520ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE
  304. K203079MR Conditional Sticky Pad Electrode
  305. K130014A1C GEAR SYSTEM
  306. K252369Boston Pico755
  307. K161125OptiCross X, 40 MHz Coronary Imaging Catheter
  308. K953410BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR
  309. K241169Entarik NI Feeding Tube System
  310. K022622CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
  311. K874138ACCUCOM 2
  312. K914273A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
  313. K823685FILE TYPE H (HEDSTROEM) ENDODONTIC
  314. K822394TICARCILLIN SYSCEPT. DISKS
  315. K171684Epix Electrosurgical Probe with Smoke Evacuation
  316. K020229R & D BODY FLUID CONTROL
  317. K162328Winner Transfer Wheelchair
  318. K013469EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
  319. K043538HYPERTRANSIT INFUSION CATHETER
  320. K852181ELECTROCARDIOGRAPH
  321. K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
  322. K250141Synthecure Synthetic Calcium Sulfate
  323. K870983NOCTURNAL PENILE TUMESCENCE MONITOR
  324. K023284MIRAGE FULL FACE MASK SERIES 2
  325. K921951MPG 65-80-100 X-RAY GENERATOR AND CONTROL
  326. K111933COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
  327. K170451FDX Console (DR-ID300CL) Software
  328. K837506KODAK T-MAT G FILM SO-381
  329. K213735dS Sentinelle Breast 16ch 1.5T Coil
  330. K120054ULTIMA NEO
  331. K921720MRT-50A QD SPINE COIL
  332. K914876OPTI-AMP
  333. K895546MODIFIED SPANTRON FRAME FREEZE
  334. K133127LIPIFLOW THERMAL PULSATION SYSTEM
  335. K883371MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)
  336. K781655NEPHELRATE ANTISERUMS 1GA
  337. K122085STINGRAY CERVICAL CAGE
  338. K874390CRACK-IT CANNABINOID SCREEN
  339. K241932OSSIOfiber® Compression Staple
  340. K781572NORMAL HEMATOLOGY CONTROL UNASSAYED
  341. K760482SUNLAMP (F40-UVB & F20-UVB)
  342. K033903MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING…
  343. K802789TUBULAR BANDAGE
  344. K052053LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
  345. K992300QUICK-SERTER, MODEL 395
  346. K170830Unison-C Anterior Cervical Fixation System
  347. K150125Elite Nitinol Fixation System
  348. K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse…
  349. K971152ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
  350. K984594LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
  351. K790038DISK, BETA-LACTAM
  352. K221143Nitrile Exam Gloves (Blue, Black)
  353. K896346GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK
  354. BK040069Automated Blood Cell Separators
  355. K092698QUICKVUE INFLUENZA A+B TEST
  356. K211881AI Segmentation
  357. K770444SPECTROPHOTOMETER ANALYSIS SYS., AA-375
  358. K971589REACH ANTIBACTERIAL TOOTHBRUSH
  359. K181313BenQ Diagnostic Ultrasound System
  360. K820187SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
  361. K212875Spectral CT on Rails
  362. K181970MectaLIF Posterior Extension
  363. K901176#23 EXPLORER
  364. K931129TECHLAB 1-HOUR TOX-A-TEST
  365. K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A)…
  366. K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
  367. K100785BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
  368. K770580PEAK FLOW METER
  369. K142218Coalition AGX Plate and Coalition AGX Spacer
  370. K944724HEALTH IMAGE INC. HI STAR
  371. K905297DIAVENTIONAL CATHETER
  372. K212287Dayspring Lite
  373. K850089MINIMUM ESSENTIAL MED. (MEM) W/EARLE'S SALS L-GLUT
  374. K944672INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES
  375. K990958ORTHOGONAL EP CATHETERS
  376. K881284COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
  377. K873364HYPERTHERM TECHNOLOGIES' HEAT COMPRESS
  378. K770391COVER, ARMBOARD, DISPOSABLE
  379. K212896Visible Patient Suite
  380. K802585FEEDING TUBES IN SILICONE 5,6,8&10 SIZES
  381. K161247Relizorb
  382. K874393ENTERAL FEEDING TUBE
  383. K081554TOKUYAMA TISSUECARE
  384. K895253PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
  385. K223502MR Diffusion Perfusion Mismatch V1.0
  386. K913006BACTIDROP(TM) DOBELL & O'CONNOR IODINE
  387. K910429SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
  388. BK830001Media, Potentiating for In Vitro Diagnostic Use
  389. K901161SOLAR SHADES(TM) SUNGLASSES
  390. K043123APEX MODULAR HA HIP STEM
  391. K893105SAFETY TOUCH VINYL EXAMINATION GLOVES
  392. K831134PHOENIX 60/60 PROCESSOR MODULE
  393. K813528LENS-PAC
  394. K203011Monster Screw System
  395. K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
  396. K973379STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
  397. K201197TruAbutment DS, TruBase S
  398. K864877TRI-LEVEL LIGAND CONTROL
  399. K974186ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
  400. K222734Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
  401. K090092SOCKIT! AND MCMERLIN DERMAL WOUND GEL
  402. K896692AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
  403. K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…
  404. K931157BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP
  405. K924057DISPOSIBLE ELECTRO COAGULATION PROBE
  406. K043085MODIFICATION TO: PNEUTON VENTILATOR
  407. K931367VACUTAINER BRAND LUER ADAPTER
  408. K801874MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD
  409. K921645AMSEN SPINE IMPACTOR INSTRUMENTS
  410. K851474VYGON SPINAL ANESTHESIA TRAY CODE NO. 190
  411. K915054STATIM CASSETT AUTOCLAVE, MODIFICATION
  412. K811769LAPAROTOMY PADS
  413. K163123Q-Switched Nd:YAG Laser Therapy Systems
  414. K233659Suture Wing
  415. K945870R&D PART NOS. 5490, 5541, 5358, 5497
  416. K792452PNEUPAC RESUSCITATOR INSTANT ACTION SET
  417. K823080VAKUTAGE
  418. K06194721.3 INCH MONOCHROME LCD MONITOR
  419. K143694Rhondium One-Visit-Crown(OVC)
  420. K913677ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
  421. K942369GAMMA-BCT INTACT PTH
  422. K200430Precice® Ankle Salvage System
  423. K011178WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
  424. K232674PainFreeze II
  425. K210779Powder Free Nitrile Patient Examination Gloves, Blue Color
  426. K250608Mako Total Knee Application (3.0); Hybrid Tip Pointer
  427. K791131FLU VEN TR-1
  428. K950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
  429. K851956VPDS-1 VENNES PANCREATIC DILATION SET
  430. K161312Sysmex Automated Blood Coagulation Analyzer CS-2100i
  431. K223495Zeolite Hemostatic Cotton
  432. K972596DEPUY DURALOC ACETABULAR CUP SYSTEM
  433. K033871IM TOTAL FEMUR
  434. K923530COULTER MULTI-Q-PREP
  435. K893554ARGENCO 60 TYPE IV DENTAL GOLD ALLOY
  436. K802864SIEMENS-ELEMA PULSE GENERATOR 678
  437. K131272SIREN EPCR SUITE
  438. K233935DigiLine Direct Print Aligner System
  439. K110278CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
  440. K891045MIYA HOOK
  441. K974308MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
  442. K926341UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT
  443. K223348My3D® Personalized Pelvic Reconstruction
  444. K030829VPT METER
  445. K251680Biosteon® Screw
  446. K142352CardiacLinx
  447. K852651THERA-TRONIC THERAPEUTIC TREATMENT TABLE
  448. K170602Continuous Single Culture-NX Complete (CSCM-NXC)
  449. K003202FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
  450. K083149ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
  451. K952019PRIMA ADULT GAS SAMPLING CIRCUITS
  452. K950610FIKO FO;, TJER,A; O,AGER FTO-1000
  453. K052205CAPIOX AF125X ARTERIAL FILTER
  454. K240909Samsung ECG App v 1.3 (ECG)
  455. K971868IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
  456. K111189SYNTEC DENTAL IMPLANT
  457. K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
  458. K100089SYNTHES T-PAL SPACER
  459. K220579Hybrid C70
  460. K240843GENESIS (MS-P02-GEN)
  461. K150427Vantage Titan 1.5T, V3.1, MRT-1510
  462. K132866NAUTILUS SPINAL SYSTEM
  463. K780459CLEARTONE MODEL-1 & 2 HEARING AIDS
  464. K973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
  465. K862856PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
  466. K143042SonarMed AirWave, Airway Monitoring System
  467. K003395GEN-PROBE APTIMA COMBO 2 ASSAY
  468. K842294DIALYSATE ADDITIVES
  469. K951927COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
  470. K955144RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000
  471. K260839Protaryx Transseptal Puncture Device (PTX2-001)
  472. K864719PFLEX EM(TM) (EXERCISE MONITOR)
  473. K973216FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
  474. K944435DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
  475. K772301LAPAROSCOPY DRAPE, BOUNDARY
  476. K832721DIGITAL SPHYGMOMANOMETER UA-231
  477. K940740SKI VECTOR NON PRECRIPTION SUNGLASSES
  478. K191803Orthopedic Fixation Pin
  479. K860582TBI NEEDLE
  480. K801483MARK IV SYRINGE
  481. K062685EBI ARAY SPINAL SYSTEM
  482. K970681ALTRA NOVA 200 HEMODIALYZER
  483. K843096CRISTY/COTE
  484. K942103L-CATH CATHETER SYSTEM - PORT L-CATH
  485. K221829Wet Flavored Personal Lubricants
  486. K200287BP-BT Kiosk
  487. K925636AHMED GLAUCOMA VALVE IMPLANT
  488. K943700KARL STORZ BRONCHOSCOPE ACCESSORIES
  489. K083596REEKROSS FAMILY OR OTW PTA CATHETERS
  490. K002103SIMPLICITY SPINAL SYSTEM
  491. K936052BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING
  492. K092486VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
  493. K013553PRE-LOADED ULTRAFIX RC
  494. K934754THE HILL HI-LO TABLE
  495. K172147STAR 65
  496. K822197NEEDLE HOLDERS
  497. K992591CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
  498. K770399VALVE FOR CLOSED SYS. URINARY DRAINAGE
  499. K780857MIXING BOWL & SPATULA, DISPOSABLE
  500. K841200RUBELLA IGG ANTIBODY ELISA TEST SYS
  501. K951512PRECISE HOSPITAL FOAM CLEANER DISINFECTANT
  502. K932734PHONAK PICO-FORTE SC-2
  503. K140499VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
  504. K033543NARCOTREND, MODEL COMPACT 4.0
  505. K834475RESPIRODYNE PULMONARY FUNCTION TEST
  506. BK160052Blood Establishment Computer Software and Accessories
  507. K001083GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES…
  508. K853362H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
  509. K921759ACRYLASTIC
  510. K022630MODIFICATION TO FOCUS
  511. K861013ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
  512. K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
  513. K000719NEOCARE 20 MICRON BLOOD FILTER
  514. K891793MICROMED LATEX EXAMINATION GLOVES
  515. K864170LEECO VIS-CUBE STREP A (EIA)
  516. K041135VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
  517. K894021MOBILE X-RAY UNIT
  518. K001428OPTIMUM WETTING AND REWETTING DROP
  519. K852836ADVANCED MEDICAL PRODUCTS MINI-M (TENS)
  520. K130774UNIVERSAL DISTAL RADIUS SYSTEM
  521. K811982STAPHASE*
  522. K820886THYROXINE T4 KIT
  523. K221011AI.ME System
  524. K023039BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
  525. K863138TERUMO RADIFOCUS GUIDE WIRE
  526. K843393LIFELINE TLE 476-04
  527. K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
  528. K771607HEARING AID MODEL 775
  529. K993820POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM…
  530. K072460HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
  531. K781142DISSCAP
  532. K050991THE ODFS DROPPED FOOT STIMULATOR
  533. K203803VASOBand Vascular Compression Device
  534. K872551SEAMED MODEL 3200
  535. K822676FITC ANTISERA TO HUMAN IGG
  536. K961864CSF/URINE TOTAL PROTEIN
  537. K231929iQ-solutions
  538. K925909GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION
  539. K182571CardioFlux with Faraday Analytical Cloud
  540. K851286RADIAL IMMUNODIFFUSION PLATES C3 & C4
  541. K840253ONE-WAY AIR VALVE
  542. K023649VITIQUE SYSTEM
  543. K172866NeuroCap
  544. K043521BIOSYAG 50 MED
  545. K092567MODIFICATION TO UNIGRAFT
  546. K083544KAT IMPLANT SYSTEM
  547. K900385ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
  548. K261745LightningWire Transseptal Puncture System (TPS)
  549. K800074VESSEL OCCLUDER
  550. K122733V2F ANTERIOR FIXATION SYSTEM
  551. K915171LOPEZ VALVE TM II
  552. K221791ProBeam 360° Proton Therapy System
  553. K896246CLP COMPREHENSIVE LIPID CONTROL-LR
  554. K990309PLUS FRACTURE HEAD PROSTHESIS
  555. K982332STERIS TEN SIXTEEN STEAM STERILIZER
  556. K870042ASSERA-PLATE PROTEIN S KIT
  557. K211109N1 TiUltra TCC Implant System
  558. K023068PAPILLON MASK SET
  559. K102477NO!NO! SKIN
  560. K193201BTL-785F
  561. K090774LIGHTLAS SELECTOR
  562. K022513MEDCOMP VASCU-SHEATH INTRODUCER SET
  563. K003892TOTAL BILIRUBIN REAGENT
  564. K051983MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
  565. K131561SAM JUNCTIONAL TOURNIQUET
  566. K914839COMPEL E
  567. K032123SHOCKWAVE SUSPENSION WHEELCHAIR
  568. K821526ACID PHOSPHATASE REAGENT SET
  569. K781725REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
  570. K053645MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
  571. K922526DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES
  572. K891934ADDWEALTH LATEX EXAMINATION GLOVES
  573. K211510uLab Systems Dental Aligner Kit
  574. K242492Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem…
  575. K161390Vinyl Exam Gloves, Powder Free, Clear
  576. K171606AOS Anterolateral Proximal Humeral Plate
  577. K790550CENTRIA SYSTEM
  578. K081455RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
  579. K933512UPSCAN
  580. K180067ACUSON X800 Diagnostic Ultrasound System
  581. K171337LENSAR Laser System – fs 3D (LLS-fs 3D)
  582. K982537TOKUYAMA SOFRELINER
  583. K891977PATIENT EXAMINATION GLOVES (LATEX)
  584. K112689SYNTHES STERNAL FIXATION SYSTEM
  585. K885283ASPIRATING AND IRRIGATING CYSTS NEEDLES
  586. K210129RF Thermal System
  587. K111265METASURG SUBTALAR IMPLANT
  588. K834210STRATUS TOTAL THYROXINE FLUOROMETRIC
  589. K852868WUNDERSHADE
  590. K960340CONSENSUS APEX DOME HOLE PLUG
  591. K123094ORTHODONTIC CERAMIC BRACKETS
  592. K993045BARIATRIC LAPAROSCOPE, MODEL 367
  593. K760228ANESTHESIA MACHINE, CHEMETRON
  594. K170319Low Profile Non-Balloon Feeding Device
  595. K191810Curiteva Pedicle Screw System
  596. K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
  597. K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
  598. K222729Electrical Scooter, WT-T4QP2
  599. K883570HISTO-CHECK FUNGAL CONTROL SLIDES
  600. K170155EK12 Algorithm
  601. K913235DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
  602. K052437MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
  603. K897154NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
  604. K803302PREHEPARINZED SYRINGE
  605. K852182EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER
  606. K131428RADVISION
  607. K041511TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
  608. K192523CMOS Video Esophagoscope SSU
  609. K063613MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
  610. K924137CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)
  611. K252557Lumify Diagnostic Ultrasound System
  612. K964659ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
  613. K023491AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
  614. K220434Blue Eye (TS-905)
  615. K973514ACTIVE INTACT PTH
  616. K192903RS85 Diagnostic Ultrasound System
  617. K120146QUARK SERIES
  618. K910114OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE
  619. K791316MEDTRONIC MODELS 5984/5985
  620. K032237N/T PROTEIN CONTROL
  621. K883226OPTICAL OR EYEGLASS FRAME
  622. K950956DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
  623. K040082PORE-SI BONE GRAFT SUBSTITUTE
  624. K802168DRAGER AV2 ANESTHESIA VENTILATOR
  625. K242378Eclipse Treatment Planning System (18.1)
  626. K950868BELTONE COMPOSER 2000
  627. K210671Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104…
  628. K803239SOFTGOOD PRODUCTS AND SPLINTS
  629. K780243TAMPON, RELY MODIFIED
  630. K011047GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
  631. K761126EXTRA LARGE LONG HANDLED SPONGE
  632. K1519053400E series; E5400 series; E6400 series; Sundazzler series
  633. K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+
  634. K220176Elecsys AFP
  635. K020189EXEL BUTTERFLY SCALP VEIN SET
  636. K090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
  637. K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
  638. K934371BIP MULTI MODIFICATION
  639. K862016PACH-PEN SURGICAL DRAPE
  640. K022167PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
  641. K203220cobas BKV
  642. K123083COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
  643. K993867BAYER ADVIA IMS SYSTEM
  644. K973668CARDIAC TROPONIN-I (TROP) CALIBRATOR
  645. K931895ENDOSCOPE ACCESSORY
  646. K962549VIDAS CREATINE KINASE MB ASSAY 30-421
  647. K253304IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
  648. K871092HORSE BLOOD AGAR, ENRICHED
  649. K802681HELIOBOND
  650. K962403NOBLEPHARMA WIDE ACCESSORIES
  651. K884581RELIANT OXYGEN CONCENTRATOR
  652. K823368DADE ESR KIT
  653. K843779AUTOLOADER II
  654. K914704FO69 FANCY MASSAGER
  655. K894061STUDIO UNO
  656. K982551ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM…
  657. K871039STACHROM PROTEIN C TEST KIT
  658. K837200BRITT SURGICAL PHOTOCOAGULATOR SYSTEM
  659. K091202WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING…
  660. K843643COLOR DOPPLER 880
  661. K831899ENSWELL
  662. K003529SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
  663. K800372SANITARY NAPKINS, MAXI 30'S
  664. K982939BTF THIN FILM WOUND DRESSING
  665. K873190MEC-I-TRON, MODEL P-1
  666. K093338SELF ADHESIVE COMPOSITE LUTING CEMENT
  667. K991348IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
  668. K091123ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
  669. K884397PHARMASEAL STERILE WOUND CARE DRESSING
  670. K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)
  671. K982903SULZER ORTHOPEDICS FLUTED STEMS
  672. K994290BARD ENDOSCOPIC SUTURING SYSTEM
  673. K062214BRACHYSCIENCES STRANDPORT
  674. K040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
  675. K914143KODAK X-OMAT 480 RA PROCESSOR
  676. K122352NUVASIVE PRECEPT SPINAL SYSTEM
  677. K082420TRACHEOSCOPIC VENTILATION TUBE (TVT)
  678. K850379DIRECT BILIRUBIN FOR DEMAND ANALYZER
  679. K944888MEDALIST
  680. K940428INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR
  681. K873338HORN CUSTOM AID
  682. K003514ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
  683. K240942CINA-CSpine
  684. K943837CHIN UP
  685. K012380MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
  686. K243037Diode Laser System model Dawn-S
  687. K240099Ziehm Vision RFD
  688. K854830ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
  689. K961737CERA ONE ABUTMENT SYSTEM
  690. K854135HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A
  691. K150270ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH…
  692. K963125M AND R REUSABLE ELECTRODES (MULTIPLE)
  693. K923859PREMIER BLASTOMYCES
  694. K872971PERMANENT MYOCARDIAL LEADS MP SERIES
  695. K082262LDR SPINE ROI INTERBODY FUSION SYSTEM
  696. K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
  697. K881992SYRETTE
  698. K915872LATEX PATIENT EXAMINATION GLOVES
  699. K820764IVAC MODEL 160 AIR-IN-LINE SENSOR
  700. K970939VISTA V-38 CIC
  701. K770355PIPETTOR W/DETIPPER
  702. K811403AXICARE BREAST PUMP MODEL
  703. K063795GUARDIANCATHETER-URINARY DRAINAGE CATHETER
  704. K261418Liquick X-treme, Liquick X-treme Plus
  705. BK241062Blood Establishment Computer Software and Accessories
  706. K915492RSP MEGA SAMPLE PROCESSOR
  707. K853062INTRA-AORTIC BALLOON PUMP MODEL K2000
  708. K032280SIREMOBIL ISO-C 3D
  709. K926439MA25 - PORTABLE AUDIOMETER, MODIFICATION
  710. K832561EPCOR MULTIELECTRODE TEMP. PERVENOUS
  711. K081114G-1 V5
  712. K853558DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
  713. K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact…
  714. K913240DIGITOXIN (FPIA) KIT
  715. K844129SHURE GRIP TYING FORCEPS
  716. K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
  717. K971968SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
  718. K101892HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL…
  719. K830381STERILE SAFETY PINS
  720. K905471TROCAR ACCESS SHEATH
  721. K152301Background Pattern Classification [BPc(TM)]
  722. K981034SILENT NIGHT II
  723. K854807LIFE PAC
  724. K141798SYPHER SPACER SYSTEM
  725. K771658IDENTOFLEX
  726. K884730SHILEY PERC TRACHEOSTOMY SYSTEM
  727. K810102INFANT ECG ELECTRODE #60-1029
  728. K020246MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
  729. K092301POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
  730. K062037TRIATHLON LOW PROFILE TIBIAL TRAY
  731. K002260SPINA SYSTEM
  732. K192198Conformis Hip System
  733. K920756FELDMUHLE CERAMIC HEAD
  734. K892875BIAD NUCLEAR IMAGING SYSTEM
  735. K822023DESERET SUBCLAVIAN JUGULAR CATH. SET
  736. K801880MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS
  737. K802226SECHRIST SERIES 3500 AIR-OXYGEN MIXER
  738. K884781OPTI-POINT
  739. K120272AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
  740. K212898Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With…
  741. K131814AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
  742. K071849ALLOFUSE GEL AND PUTTY
  743. K012077IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
  744. K941068AUROLITE CB80
  745. K843517MINUTEMAN CO2 MICROSURG LASER DERMATOL-
  746. K844515VIOLET RED BILE AGAR
  747. K896093A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT
  748. K170808Unity Total Knee System
  749. K881254STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
  750. K093998KNEEALIGN SYSTEM WITH REFERENCE SENSOR
  751. K884607MT/S (SOFTWARE RELEASE 3.1)
  752. K003454A1-CS-SB Y-ADAPTER, MODEL 124 871
  753. K811871BACTERICIDAL INCISE DRAPE
  754. K791448HEMODIALYZERS RP-510 AND RP-514
  755. K981843AST
  756. K883805ROCKET SEX CRIME KIT
  757. K954965ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES
  758. K180204CranioMaxillofacial Fixation (CMF) System - CMF Visionare
  759. K120509STRYKER ALL SUTURE ANCHORS
  760. K852723FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420
  761. K060636PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
  762. K051428VTRAC EXCIMER LAMP SYSTEM
  763. K043082THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
  764. K935417JO-1 EIA TEST KIT
  765. K822971SALIVA SUBSTITUTE
  766. K261686Elecsys Phospho-Tau (217P) Plasma
  767. K133078K-ETCHANT SYRINGE; NEEDLE TIP (E)
  768. K173817Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
  769. K980904MUCHECK MONITOR UNIT VALIDATION PROGRAM
  770. K083330ECHOTIP ULTRA ULTRASOUND NEEDLE
  771. K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
  772. K070982CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
  773. K772034GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1
  774. K122842RADREX-I, SW V4.00 MODEL DRAD-3000E
  775. K841334RICHARDS FIXATOR SYSTEM
  776. K963434VISCOUS FLUID SYSTEM
  777. K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
  778. K943180INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM
  779. K864607EASY-TEST QUINIDINE ITEM NO. 67---/95
  780. K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
  781. K860015MODIFIED CHERNE CAD DETECTOR
  782. K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…
  783. K943340CORDIS STEERABLE GUIDEWIRE
  784. K253917ARION ARC System
  785. K851407SURGICAL TOWELS
  786. K172012star RF Electrode, VIVA RF Electrode
  787. K060949DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
  788. K800441RUDD-CLINIC HEMORRHOIDAL FORCEPS
  789. K133022ZEDVIEW
  790. K823559AFP PULSE GENERATOR
  791. K950470DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
  792. K960603SAS SALMONELLA H Z23 ANTISERUM
  793. K071681CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
  794. K781430PREGELLED DISPOSABLE E.K.G. ELECTRODE
  795. K863802VMAX KINETIC MICROPLATE READER
  796. K945701SURGILENE(R) SUTURES
  797. K854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
  798. K253493Dentis SQ-SL AXEL Fixture
  799. K031341STICK FLOW
  800. K040566RESMED HOSPITAL NASAL MASK
  801. K102539ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
  802. K831996MICRO SURGICAL HANDLE
  803. K102211CRUISER 18 GUIDEWIRE
  804. K882327PACER SENSING ANALYZER (PSA 100)
  805. K990395BARRIER SURGICAL GOWNS
  806. K001553BREAS PV 100 CPAP SYSTEM
  807. K872175TDXR FLECAINIDE
  808. K914211CATH CONTROL
  809. K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
  810. K891690KODAK EKTASCAN IMAGE MANAGER
  811. K003482PROCLUDE-SENSITIVE
  812. K900680EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS
  813. K152905ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
  814. K921756ELECTRONIC INSUFFLATOR MODEL 2054.61
  815. K902892CELL-DYN CALIBRATOR
  816. K102112CRITICOOL PRO
  817. K953986POWDERFREE LATEX GLOVE
  818. K182618SleepImage System
  819. K952697TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
  820. K241145TLAB® Transvenous Liver Biopsy System (TF-18C)
  821. K051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
  822. K990727SYNEFLASH & SYNEVIEW
  823. K182751Reusable Temperature Probe
  824. K041925ST360 SPINAL FIXATION SYSTEM
  825. K813188INFANT PHOTOTHERAPY LIGHT
  826. K131466MAPCHECK2, ARCCHECK
  827. K991250QUANTUM VERSATILITY IMPLANT SYSTEM
  828. K823752EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
  829. K172484A-CIFT SoloFuse
  830. K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
  831. K042864IMPLANT SCIENCES CORP, MODEL HDR-4140
  832. K984079INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
  833. K912833CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
  834. K981797B-D PEN ULTRA
  835. K850091BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE
  836. K771657EMIT THYROXINE CONTROL
  837. K962622INTRA-ORAL THERMOPLASTIC SHIELD
  838. K771449ARTEOIAL TONOMETER ML-105
  839. K972875COSMOPOST
  840. K111900NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
  841. K120930CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH…
  842. K803238INTRAVASCULAR CATHETER
  843. K120239ELEVANCE
  844. K820474P-S SUCTION RESERVIOR
  845. K962644VIGOR COMPRESSION HIP SCREW SYSTEM
  846. K822614BLOOD PRESSURE MONITORING DEVICES
  847. K083463DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION…
  848. K840194EMIT ST SERUM BARBITURATE ASSAY
  849. K260880SedLine Sedation Monitor
  850. K233597Sonosite LX Ultrasound System
  851. K072894SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
  852. K100927SURGIAID
  853. K9344493-CHANNEL K-AMP
  854. K882724MICROTEK PROBE DRAPE
  855. K771779CATHETERIZATION SYS. URINARY DRAINAGE
  856. K010047INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
  857. K915538OVER THE WIRE STONE BASKET
  858. K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert…
  859. K962944TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
  860. K911709STOCK CANAL, IN-THE-EAR HEARING AID
  861. K050851DELTA PUNCTUM PLUG
  862. K982116AQUACEL HYDROFIBER WOUND DRESSING
  863. K913864PCP DIRECT RIA KIT (I-125)
  864. K991175MODIFICATION TO ALCYON DIRECT BILIRUBIN
  865. K230276TECHFIT DISRP® System
  866. K040158MFCD 2320
  867. K193219G Surgical Marksman System
  868. K801937BLEPHAROMETER
  869. K133630GMK SHORT STEM
  870. K130695Z5 DIAGNOSTIC ULTRASOUND SYSTEM
  871. K911740SALTER LABS NEONATAL NASAL OXYGEN CANNULA
  872. K932930CANDELA MINIBRUSH
  873. K955474NEO-PNEUMOCATH
  874. K012160COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
  875. K932153THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME
  876. K141984FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
  877. K800650MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
  878. K862041WM10, WM20, WM30 POWER MASSAGER
  879. K082094BARD PTFE (TEFLON) COATED GUIDE WIRES
  880. K190868Cleerly Labs
  881. K810018SURG-FLEX 5 SURGICAL LIGHT
  882. K180477Straumann PURE Ceramic Implant System
  883. K840535DISPOS. ANESTHESIA FACE MASK
  884. K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System
  885. K872086ACUSYST-JR
  886. K895677THE MURRAY MOBILIFT(TM)
  887. K170172UNiD Spine Analyzer
  888. K760734REGULAR AND WIDE SKIN STAPLES
  889. K252698NightGuard Aire Max
  890. K781197STICK, UTILITY
  891. K060790BREAS, MODEL HA01
  892. K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
  893. K933867UNIVERSAL INSET PATELLA
  894. K901380CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
  895. K880599POCKET MANOMETER
  896. K181359InterActive SMARTBase Abutments
  897. K880925DISPOSABLE WET FIELD ERASER
  898. K150981SMV Scientific Bone Screws
  899. K802083CATHETER INSERTION TRAY
  900. K884867OPTIFIELD I AND II AUTOMATED PERIMETERS
  901. K091035FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
  902. K962142SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM
  903. K854215DYNAFEED
  904. K941870LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
  905. K262290REMEDY POLY+PLUS SNAP FIT Acetabular Cup
  906. K073161REPLUS DENTAL IMPLANTS (HA)
  907. K132243BARLE TISSUE ADHESIVE 2
  908. K904231MODEL OSP, SANDHILL AMS
  909. K171344Xenocor Xenoscope Laparoscopic System
  910. K121514ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
  911. K791721ULTRAVUE BLENDED BIFOCAL LENS
  912. K861335STORZ COMPUSCAN 68K
  913. K111326OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
  914. K834204MIDDLEBROOK & COHN 7H11 AGAR BASE
  915. K031785MACROPORE CARDIO-WRAP (TS)
  916. K781582PAPANICOLAOU STAIN EA-36
  917. K012238DOSERIGHT
  918. K872820SAFETY SYRINGE
  919. K250947VistaSoft 4.0 and VisionX 4.0
  920. K900885FUJI MEDICAL LASER IMAGER
  921. K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
  922. K073095TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
  923. K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
  924. K821558LEVEL II CONTROL SERUM
  925. K933618EAGLE MEDICAL ANTI-FOG KIT
  926. K211991Catalyst R1 Reverse Shoulder System
  927. K022558NGT
  928. K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
  929. K974172SILGEL TOPICAL GEL SHEET
  930. K772050TDL-100 B
  931. K822819TRIMED 510 APNEA MONITOR
  932. K244048Medi Lift Mask
  933. K770911MEDISHIELD JORDON LIFTING FRAME
  934. K071806ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
  935. K881067NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK
  936. K993584MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
  937. K882802STORZ DISPOSABLE BIPOLAR PENCILS
  938. K812901125I FERRITIN RADIOIMMUNOASSAY KIT
  939. K992644SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
  940. K221686NovoSorb Matrix
  941. K961694IMPACT
  942. K171128SIGNA Premier
  943. K050801URISCAN OPTIMA II URINE ANALYZER
  944. K132792ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
  945. K892034PATIENT EXAMINATION GLOVES (LATEX)
  946. K151570Carestation 620/650/650C
  947. K896808IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I
  948. K871436PREDICTOR
  949. K140910CENTERCROSS CATHETER
  950. K884706CHLORIDE TEST (CL) ITEM #65659
  951. K124058CREO STABILIZATION SYSTEM
  952. K211808Medcare Powder-Free Blue Nitrile Patient Examination Gloves
  953. K230908Hand Trauma Threaded Nail System
  954. K9627594F NYLEX ANGIOGRAPHIC CATHETER
  955. K091783THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
  956. K111831MX-7000 MICROXEL
  957. K051486NORWOOD ABBEY CENTURION SES EPIKERATOME
  958. K021312EBI DFS OPTIROM ELBOW FIXATOR
  959. K932592BRACE NEUTRALIZER
  960. K881217GENT-L-KARE STERILE URINARY LEG BAG
  961. K971973KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER
  962. K181034Pocket Colposcope System
  963. K832439CREATININE REAGENT SET
  964. K122978SANICLAVE 102, MODEL RS-SC-102
  965. K180380vital signs monitor
  966. K003976BAUMER MULLER HIP PROSTHESIS
  967. K062836CITADEL ANTERIOR LUMBAR PLATE SYSTEM
  968. K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…
  969. K160377V-varnish Premium
  970. K952026PYRILINKS POLYCLONAL ASSAY KIT
  971. K122506SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
  972. K061781MULTILINK SPRINT
  973. K860208QUADRA-TITER I.D.
  974. K893693H.U. I.V. DROP COUNTER
  975. K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
  976. K953686HELISAL RAPID BLOOD TEST
  977. K822255RIGID SUCTION TIPS
  978. K771428TENCKHOFF PERITONEAL TUBING ADAPT.
  979. K811392AMES SERA-PAK GLUCOSE REAGENT
  980. K050865BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304…
  981. K890440LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)
  982. K001350PATIENT MATCHED TITANIUM ALLOY TROCHLEA
  983. K130788CAPELLA
  984. K182497OsteoCool RF Ablation System
  985. K002186VASCULAR ASSIST
  986. K122465MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
  987. K153286iHealth Align Gluco-Monitoring system
  988. K953072MEROCEL VAGINAL PACK
  989. K961831STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
  990. K811151COLLARLESS TOTAL HIP FEMORAL COMP. SYS
  991. K013574ACCENT
  992. K061350LITHODIAMOND ULTRA
  993. K173595Shear Wave Quantificational Ultrasound Diagnostic System
  994. K973326QUIKPAC II ONE STEP BENZODIAZEPINE TEST
  995. K011277HARD RELINER
  996. K222450LVIS NeuroMatch
  997. K993878JE 2000
  998. K011810ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
  999. K001171DELTA 16 TACT
  1000. K771532SPIROMETEO & LUNG EXERCISER, 4601

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