Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K842461TONGUE DEPRESSOR
  2. K211169Bronchoscope System
  3. K911872PHILIPS RIGID VOLUME COILS
  4. K813125MICRO TRANSDUCER CATHETERS
  5. K935117EMIT(R) IIC OPIATE ASSAY
  6. K771218INTRA-ARTICULAR SHAVER
  7. K112447GRANDIO CORE DUAL CURE
  8. K943563COMFIT BLUE POWDER FREE EXAMINATION GLOVES
  9. K852184ELECTRO-CAUTERY KNIFE CLEANER 6000 1
  10. K790711ANTISERA TO HUMAN FRAGMENT
  11. K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
  12. K831047BIOLOGIC SYSTEM BL 101
  13. K925075SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
  14. K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES
  15. K915500LESTER PRESS FIT HIP PROSTHESIS
  16. K993740MAMEX
  17. K053220VERAVIEW IC 5, MODEL XDP1
  18. K940391PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
  19. K133381OMNI ARC MONOBLOCK HIP STEM
  20. K883439INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
  21. K113285LDR SPINE USA AVENUE L INTERBODY FUSION
  22. K905003BIO-GUARD SHAVE PREP TRAY
  23. K241459MOTUS PRO Family
  24. K770920THORACIC DRAINAGE SET, ARGYLE DUAL
  25. K873130WASH SOLUTION KIT
  26. K894218NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
  27. K121024LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS…
  28. K151646ProTech Plus
  29. K841869COOPER LASERSONICS, 8000 ND.YAGLASER
  30. K951572FS-38X, FIBER SIGMOIDOSCOPE
  31. K243392Infusomat® Space Volumetric Infusion Pump Administration Sets
  32. K180295Hamilton-G5
  33. K972378SANAPHON N
  34. K060312MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)
  35. K781474PREAMPLIFIER MODELS 8101PI & 8102PI
  36. K781807REAGENT, FIREFLY #395
  37. K940860CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
  38. K932260FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE
  39. K061522TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
  40. K232482MAGNETOM Viato.Mobile
  41. K770108TUBE HOLDING DEVICE
  42. K9140748000 SERIES VOLUMETRIC PUMP SOLUTION SET
  43. K171176M-CATH Microcatheter
  44. K822423BABY TEMP PACIFIER
  45. K090888NEWPORT HT70 FAMILY OF VENTILATORS
  46. K963992CAPILLARY ADAPTOR ACCESSORY
  47. K940035KIT,I.V. START
  48. K231837Brainomix 360 Triage LVO
  49. K050932DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
  50. K871328DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
  51. K071037SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
  52. K772175CATHETER SYSTEM, COPE/EISENBERG
  53. K841247SPC DISPOSABLE CUTTER
  54. K2027221212FCA
  55. K905381MANHANDLER
  56. K861347R1596 POWERED EXERCISE EQUIPMENT
  57. K894407ABBOTT SPECTRUM(R) CALCIUM REAGENT
  58. K955729LACTOSORB TRAUMA PLATING SYSTEM
  59. K800206ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
  60. K062390CRYSTALVIEW R200
  61. K771680ARMOR-KOT SURGICAL INSTRUMENTS
  62. K220260Hercules Syndesmosis Implant System
  63. K140521TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH
  64. K823109GENERIC PREGNANCY TEST
  65. K042021EXACTECH EQUINOXE SHOULDER SYSTEM
  66. K140312EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
  67. K122106SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON…
  68. K800408ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE
  69. K160722CorticaLINK Spinal Fusion Platform
  70. K193034AXS Infinity LS Plus Long Sheath
  71. K811124AIM SYSTEM (FOR IGM)
  72. K770286VENTILATOR BREATHING CIRCUIT
  73. K260274Airlock® Ankle Plating System
  74. K843162EMIT 700 OPIATE ASSAY
  75. K091943POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
  76. K881057PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER
  77. K983307MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
  78. K092912STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY)…
  79. K090284RES-Q INFANT WEDGE AND SLING
  80. K173589Prizma
  81. K934083PLAYTEX ULTIMATES TAMPONS
  82. K900466MOBILIMB W1 WRIST CPM UNIT
  83. K072206ERCHONIA EML LASER
  84. K884792VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES
  85. K021941SAMPLOK LUER KIT
  86. K083250NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
  87. K010458THE MAESTRO SYSTEM
  88. K230876RI.KNEE Adjustable Tibia Cut Guide
  89. BK010046Automated Blood Cell Separator -Filtration
  90. K865077ACCU-FLO REGULATOR
  91. K020576VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
  92. K112513EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
  93. K943974EURO TECH MARQUISE CHIROPRACTIC TABLE
  94. K031130YA MEI FIRST AID KIT
  95. K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
  96. K180396miraDry System
  97. K810592NUCLEAR ANTIGENS
  98. K020657ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
  99. K831361BETA-PREG
  100. K935775LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS
  101. K120800NVISION VLE IMAGING SYSTEM
  102. K870176GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
  103. K896784DISPOSABLE URODYNAMIC CATHETER SET
  104. K970084LINK CERCLAGE WIRE SYSTEM
  105. K901510ENZYMATIC THEOPHYLLINE REAGENT, #500-82
  106. K792020AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER
  107. K950835SCIMED CHOICE PT PTCA GUIDE WIRE
  108. K252608AI-Rad Companion Prostate MR
  109. K070385TI-TAMED SPINAL SYSTEM
  110. K060847MAGSTIM 200-2
  111. K874298MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
  112. K023710VISORB SWIFT
  113. K082469UNITED U2 PATELLA
  114. K935868DYNAPHOR(TM) TWO
  115. K212675Aspira Peritoneal Drainage System
  116. K250952Baby Gorilla®/Gorilla® Plating System
  117. K981833SILIMED NASAL L SHAPED IMPLANT
  118. K133952VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
  119. K250344BD Phoenix™ Automated Microbiology System
  120. K182894HM70A Diagnostic Ultrasound System
  121. K800958PERSONAL SITZ BATH KIT
  122. K052248DORSAL NAIL PLATE, ANATOMICAL
  123. K940289ABBOTT PRISM ANALYZER
  124. K210588Black Nitrile Powder Free Patient Examination Glove, Non Sterile
  125. K843040COPAL DIGITAL THERMOMETER UF-10
  126. K946237ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
  127. K102556VOLPARA, VERSION 1.3
  128. K940426MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
  129. K171874Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and…
  130. K142243LessRay with Tracking
  131. K904361KLEARTEX LATEX SURGEONS GLOVES
  132. K981720IQ SYSTEM
  133. K822417NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
  134. K831023REFERENCE BUFFER PH 7.382
  135. K780628HALOGEN EXAM. LITE #48400
  136. K253642Jada System (Jada-2002)
  137. K940383LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK
  138. K132369MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
  139. K073028VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30
  140. K213788TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
  141. K152430All Poly Tibial Component
  142. K202429Mobio Total Knee System
  143. K013287NIPRO SAFELET CATH
  144. K943126ELECTROFLEX
  145. K912122CHOLANGIOGRAPHY CATHETER
  146. K141228AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
  147. K251848Pentacam® Cornea OCT
  148. K252774Uni-C Cervical Cage System
  149. K851506SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
  150. K210707OnGuard2 Chemfort Closed Administration (CADM)
  151. K202850Concerto Versa, Detachable Coil
  152. K151102Bausch + Lomb Injector System
  153. K1329673B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
  154. K935258HYBRID SURGICAL DEVICE MODIFICATION
  155. K945223OREX ISOLATION GOWN
  156. K935872NAMTAI
  157. K850333PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
  158. K902707MODEL 9000 AT ANKLE CPM DEVICE
  159. K932641EMPTY MIXING CONTAINER
  160. K842004PERCUTANEOUS CATHETER INTRODUCER SET
  161. K022652ALPHATRAC, MODEL A 205
  162. K142581APTUS Foot System
  163. K841574QUAZAR ESOPHAGEAL STETHOSCOPE
  164. K983713PRODIMED MICROINJECTION PIPETTES
  165. K160204BSD4343 Digital Flat Panel X-ray Detector
  166. K842263MTP E.V. INFUSION PUMP
  167. K870409CHROMAGEN TEST FOR GROUP A STREP
  168. K162184Edwards eSheath Introducer Set
  169. K240501Spark™ Clear Aligner System
  170. K863241LASER ASSISTED SURGICAL LAPAROSCOPY KITS
  171. K955395DAR-2400-15B/30B
  172. K895426AMBULATORY INFUSION PUMP
  173. K933958RICHARDS TOTAL KNEE SYSTEM
  174. K070463REVERA WOUND CARE, MODEL MDW0060
  175. K092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
  176. K120818OTIS-C PLUS
  177. K241891ScreenDx
  178. K000901KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
  179. K955346VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM
  180. K874760CK 4900 SERIES, GOWN AND TOWEL PAK
  181. K051126CARDIOSCOPE SONOPLUS 3000
  182. K911247YOURS TRULY ASYMMETRICAL BREAST FORM
  183. K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
  184. K851173ABCO TRAY CARE KITS
  185. K843871PARATHYROID HORMONE C-TERMINAL RIA KIT
  186. K092796IBA PROTON THERAPY SYSTEM, PROTEUS 235
  187. K182818LOQTEQ VA Calcaneus Plate 3.5
  188. K070025C.T.M. MOBILITY SCOOTER, MODEL HS-310
  189. K143251SIGNA Creator, SIGNA Explorer
  190. K934773ARGELITE A
  191. K001878WATER PURIFIER
  192. K960575ADVANTX LCV+
  193. K182906Portable Mesh Nebulizer
  194. K851253TDX ANALYZER W/NEPHELOMETRY CAROUSEL
  195. K2316183 Layer Surgical Mask (134252531)
  196. K090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
  197. K260660SABER-C System
  198. K991537SAMSUNG RAYPAX SYSTEM
  199. K100139SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
  200. K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…
  201. K120402CRUX VENA CAVA FILTER SYSTEM
  202. K203444BEE HA Cage
  203. K913297SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH
  204. K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
  205. K002685CORDLESS COMPACT MOBILE X-RAY SYSTEM
  206. K153247Fusion Compact Navigation System
  207. K091694MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
  208. K905298TITAN TOTAL HIP DEVICE
  209. K971375GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
  210. K182771ISS-JAZZ Screw System and JAZZ CAP SP
  211. K062934SIERRA
  212. K251717Freedom® Total Knee System – Titanium Tibial Base Plate
  213. K874938PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
  214. K843090UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM
  215. K843000MICRO ORGANISM GROWTH SYS-M1000
  216. K851541DART IMMUNOGLOBULINS REAGENT SYSTEM
  217. K2107723-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
  218. K150842JUSHA-M53 Medical Display
  219. K092022TISSU TRANS HARVEST TUBING
  220. K911768AMSET(TM) BONE SCREW
  221. K151866BD BACTEC Peds Plus/F Culture Vials (plastic)
  222. K994421SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
  223. K831957DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
  224. K242992RayCare (2024A SP1)
  225. K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
  226. K941897ULTRACISON HARMONIC SCALPEL HS2 BLADE
  227. K931269LEAD APRON
  228. K1325905.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE…
  229. K261693Diode laser hair removal machine (QDTM-04)
  230. K823361SWITCHING UNIT ELECTRODE CATHETERS
  231. K771797ACA TRIGLYCERIDE CALIBRATOR
  232. K072664GE LUNAR FEMUR STRENGTH SOFTWARE
  233. K994257LOCATOR IMPLANT ANCHOR
  234. K970286PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
  235. K232670HiCardi+ H100
  236. K896910CLINISTAT ALBUMIN REAGENT TEST
  237. K897010PALFIQUE LIGHT COMPOSITE RESIN
  238. K921666CARDIAC THERAPHY SYSTEM SCP 900
  239. K151842Rainbow Shine
  240. K151542A-Oss
  241. K830697VENES HIGH COMPRESSION MEDICAL STOCK-
  242. K862756PREGELLED INFANT DISPOSABLE ECG ELECTRODE
  243. K182764Biop Digital Colposcope
  244. K914714BONE DRILLS OR TAPS
  245. K894271DENLEY WELLWASH 2 AND 4
  246. K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
  247. K111010SPIDERFX EMBOLIC PROTECTION DEVICE
  248. K141586OWL CANNULAE
  249. K953119BOSWORTH RESIN II
  250. K000391VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM…
  251. K926267MOBILAIRE LIQUID OXYGEN SYSTEMS
  252. K192367Ion Endoluminal System
  253. K133122IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE…
  254. K853445IN A WINK LUBRICATING & REWETTING DROPS
  255. K801592FIBER OPTIC HOSE
  256. K220277Digital Intraoral X-ray Sensor
  257. K910082POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
  258. K982451TTCGHI-T AND TTCTN3-T-T
  259. K841490POLYSULFIDE CUSTOM TRAY MATERIAL
  260. K201439Ventilator, Non-continuous (Respirator)
  261. K102635APOLONIA LASER IMPLANT SYSTEM
  262. K102945PEDIACYN ATOPIC DERMATITIS HYDROGEL
  263. K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
  264. K933337R AND D BATTERY REPLACEMENT
  265. K954020MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
  266. K820557DERMATHPHYTE TEST MEDIUM
  267. K214038Oscar Peripheral Multifunctional Catheter system
  268. K881671MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT
  269. K041325DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE
  270. K840359POST-AURICULAR HEARING AID
  271. K841154PLAYTEX SLENDER REGULAR TAMPONS
  272. K852433INFUSAFE 205 CATOLOG NO. 205.000
  273. K170116Thermi Injectable RF Electrodes
  274. K993516HP M2600A VIRIDIA TELEMETRY SYSTEM
  275. K230606AcQMap® High Resolution Imaging and Mapping System
  276. K842757ULTRASCAN DIGITAL B
  277. K161593GMI Frontier Dental Implant System
  278. K843520WAREXIN RECOMMENDED ALTERNATIVE DIALYZ
  279. K132280ALTUS SPINE PEDICLE SCREW SYSTEM
  280. K083432DRILL FREE MMF SCREW
  281. K212093Medline Universal Grounding Pad
  282. K923697RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
  283. K023438MODIFICATION TO MONARCH SPINE SYSTEM
  284. K191875Owgels Oxygen Concentrator
  285. K851301TARGET CAT#B7850AA & B7850AB & B7850B
  286. K001059NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
  287. K070148GRAFT CONTAINMENT DEVICE
  288. K093258BLOM-SINGER INDWELLING TEP OCCLUDER
  289. K880201REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600
  290. K082627MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL
  291. K812863FETASONDE 5, #30, CENTRAL NURSING STAT
  292. K113032SNAP WOUND CARE SYSTEM
  293. K210121ROSA Partial Knee System
  294. K172651FMP Extended Liners
  295. K002931METRX SYSTEM
  296. K963899CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
  297. K855219KODAK RP X-OMAT PROCESSOR MODEL M6B
  298. K260300WatchMate Software
  299. K132853NOVAPACS
  300. K051548IRRADIA MID - LASER (S3)
  301. K861979AML II TITANIUM ACETABULUM PROSTHESIS
  302. K012688VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
  303. K873983CAPTAIN POWER SUNGLASSES STYLES: #1020 #1021
  304. K000766TRI-FIX SPINAL FIXATION SYSTEM
  305. K833104BIOTRONIK D2K UNIPOLAR PE-60/4
  306. K811094CARDIAC 1000 TM
  307. K820511BAUSCH & LOMB STERILE ALL PURPOSE SOLU
  308. K181246Zavation IBF System
  309. K811607COLUMBIA AGAR CNA W/5% SHEEP BLOOD
  310. K843543THE BIBICURE SYS DERMEPIL NATURAL HAIR
  311. K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL…
  312. K830470ANESTHESIA BREATHING CIRCUITS
  313. K110990GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
  314. K944455QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE)
  315. K092699NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
  316. K910081TBD
  317. K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
  318. K801300DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
  319. K864139RANFAC CUT BIOPSY NEEDLE
  320. K201481Centurion POCT System
  321. K964331ASC HIGH PRESSURE BRAIDED TUBES
  322. K951639COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
  323. K061570I-STYLE BONE MARROW ASPIRATION NEEDLE
  324. K083470CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
  325. K791751EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR
  326. K031080EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS
  327. K000049SUNI MAX
  328. K003315SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
  329. K781755DAP-PAK
  330. K944234TCD OR TCD NEUROPATHY STAR
  331. K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…
  332. K024360INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
  333. K180365PRAMA White Implant Systems
  334. K800571DAHLBERG #AZ BEHIND THE EAR HEARING AID
  335. K903457PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
  336. K230029NeuroStar Advanced Therapy System (Version 3.7)
  337. K151814SERVO-U Ventilator System, SERVO-n Ventilator System
  338. K024128ALLON 2001 VERSION 5
  339. K072867IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
  340. K980286ULTIMA ACETABULAR ROOF REINFORCEMENT RING
  341. K032306VERSATREK
  342. K050884ADAPTER CABLE
  343. K223749U by Kotex® Click® Unscented Menstrual Tampons
  344. K955613MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
  345. K131369FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
  346. K072102EPIVISION SL SYSTEM
  347. K840492SUN-LITE BLUE SLIT
  348. K872597FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE
  349. K213227Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
  350. K243898Chlorine Sentinel II
  351. K100409POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
  352. K031949TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
  353. K091365VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
  354. K180681Aptima Combo 2 Assay (Panther System)
  355. K896425PORGES CYTOLOGY BRUSHES
  356. K920125MRT-50 SPINE COIL
  357. K801996GUAZE BANDAGES CAT.#101-169
  358. K931093QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE
  359. K970395QUIKSTRIP ONE STEP METHAMPHETAMINE
  360. K872576COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
  361. K844504SARTORIUS MINISART SM 16596HY
  362. K172893SafeSept Needle Free Transseptal Guidewire
  363. K141737CONVENTUS PHS SYSTEM
  364. K903884KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
  365. K081079CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
  366. K903419MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
  367. K920699REMSTAR WTIH RAMP AND REMOTE MODIFICATION
  368. K253536Evala Nerve Stimulator (EPNR002)
  369. K072131M3 MONITOR
  370. K842072L-ALANINE-4-NITROANILIDE
  371. K233152GENIOVA aligners
  372. K042139VISULAS YAG III
  373. K800041SODIUM/POTASSIUM 140/5 MEQ/L)
  374. K843017ABSORBENT ENDODONTIC POINT
  375. K883431RAYMAX 2100 MODELS 2130 & 2136
  376. K233249APPRAISE-HRI
  377. K232223PlaDuo System
  378. K831284GAUZE BANDAGE
  379. K853593VESSA TRAVVLA
  380. K183391Novidia Universal Bond
  381. K121550HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
  382. K822782ACUSCREEN
  383. K940846NIL
  384. K110012ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
  385. K013767SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN…
  386. K212743MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
  387. K101523CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
  388. K781069T3 STANDARDS IN HUMAN SERUM
  389. K791622COLUMBIA AGAR WITH5% SHEEP
  390. K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
  391. K212877Arm Blood Pressure Monitor
  392. K911131STERILE SURGICAL GOWN PACK
  393. K060429TDM CONTROL SET
  394. K142692Occlusion Balloon Catheter
  395. K841974RETROGRADE KNIFE 4MM & 5MM
  396. K220767TeleScan
  397. K203491PicoLO Nd: YAG Picosecond Laser System
  398. K060720CURATIVE DENTAL ACRYLIC TEETH
  399. K934064REFLOTRON HEMOGLOBIN TEST TABS
  400. K801342DISPOSABLE ARTICULATOR
  401. K122076PERSONAL HEALTH CENTER (PHC)
  402. K111590ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
  403. K021027S2 TIBIAL NAIL
  404. K011998METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
  405. K9118423M LUTING CEMENT, PASTE A AND B
  406. K032717BIOCRYL RAPIDE INTERFERENCE SCREW
  407. K982907MAGNATEK 40
  408. K970496HEARTPORT MAZE SYSTEM: CRYOPROBE SET
  409. K240079Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)
  410. K112426XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
  411. K122996ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
  412. K895288HVA EIA KIT YAMASA
  413. K913249ACS ULTRA-1 THROMBOPLASTIN
  414. K230211CranioXpand
  415. K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12)…
  416. K950479DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM
  417. K011404FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
  418. K080759THERMOFLASH LX-26
  419. K140813REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
  420. K041776PASCO MIC AND MIC/ID PANELS
  421. K071648EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
  422. K922630MOPYLEN
  423. K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)
  424. K152249ASAHI Corsair Armet
  425. K030890SWITCHBLADE
  426. K961011DTX-200 BONE DENSITOMETER
  427. K131530DYNAMESH -CICAT
  428. K946323UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
  429. K912056GRAVITRON UPPER BODY SYSTEM EXERCISER
  430. K093642NEUTRASAL
  431. K102886CD HORIZON SPINAL SYSTEM
  432. K865035RECORD KEEPING/DATA MANAGEMENT SYSTEM
  433. K132694NUVASIVE NVM5 SYSTEM
  434. K132696TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
  435. K933007SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS
  436. K810640POLARISED LIGHT GRONIOMETER
  437. K823812VARIOUS SUPPORTS AND SPLINTS
  438. K110828DDRELEMENT
  439. K083307SYNTHASOME X-REPAIR
  440. K202655Disposable Medical Mask
  441. K961273AED CALIBRATORS
  442. K062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
  443. K955202SAS SALMONELLA H L,Z40 ANTISERUM
  444. K881734SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER
  445. K250264SugarBug (1.x)
  446. K180428Stat Profile Prime Plus Analyzer System
  447. K924430AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027
  448. K032397DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
  449. K031369MERCATOR HEALTHCARE MALE LATEX CONDOM
  450. K905264STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
  451. K153525Seneka II Polyscrew Pedicle Fixation System
  452. K052018MILTEX LIGATING CLIP
  453. K103692SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
  454. K871751QUIK-PACE NONINVASIVE PACEMAKER
  455. K963778CDR-CAM
  456. K143372AWARE
  457. K210290JACE Medical Thoracic Plating System
  458. K153675Paragon T2 Wand with Integrated Cable
  459. K150034AMT Enteral Transition Adapters
  460. K992983BAHO AUTOCLAVABLE CYSTOSCOPE
  461. K843752SIGMA PERIODIC ACID-SCHIFF STAIN 395
  462. K103117ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
  463. K873517DEKNATEL THORACIC CATHETER
  464. K913175MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
  465. K823822ANKLE WEIGHTS
  466. K760188SCISSORS, MICRO IRIS CURVED
  467. K926291SCHUL-TEC IMMOBILIZER
  468. K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
  469. K914101CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR
  470. K972692MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
  471. K953092FOSTER GRANT NON PRESCRIPTION SUNGLASSES
  472. K983980SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
  473. K980460ONPLANT ORTHODONTIC SYSTEM
  474. K871307SYVA Q-SPEC PHOTOMETER
  475. K926453SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE
  476. K830585ANVIL RETRACTOR
  477. K830521PRECISION EEG CAP W/ELECTRODE SET AND
  478. K983585LOW PH PHENOLIC 256
  479. K951550CMV BRITE ANTIGENEMIA TEST KIT
  480. K791903COULTER DIFF3 SYS. (COULTER #7400003)
  481. K890802COTUBE(TM) TSH IRMA
  482. K040334NAVIGUS PASSIVE PROBE, MODEL NP-1000
  483. K832868RESUSCITATION VALVE
  484. K170775Mini Stick ENVI Non-Vascular Introducer Kit
  485. K820962COTTON SWABS
  486. K131616EZ3D-I, E3
  487. K881015FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
  488. K093206ORTHOMAP 3D 1.1 MODULE
  489. K101181BEL-CAT
  490. K921090ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
  491. K040562LIFECLINIC, MODEL 2400
  492. K132356SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
  493. K870987CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
  494. K872856BIOPRO 32MM BALL
  495. K982490TENOR SPINAL SYSTEM
  496. K892082MAYTEX NON-STERILE LATEX EXAM GLOVES
  497. K161487VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
  498. K073225SENSEI CATHETER CONTROL SYSTEM
  499. K834324TSA
  500. K936166CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
  501. K874863RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
  502. K882874ZINC FORMALIN
  503. K890483THE PATHFINDER SYSTEM
  504. K000536SYNTHES ANTERIOR CSLP SYSTEM
  505. K810795INSTAFIL
  506. K973372AUROFILM 2000
  507. K954054MAICO PRODIGY CIC SERIES
  508. K852306REPLACEMENT REAGENTS FOR SMAC II SYSTEMS
  509. K180667SmartGrid
  510. K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE…
  511. K061532GENTLE COLON (REVISION 2.0)
  512. K022228FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
  513. K111529MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE…
  514. K770452PROTEIN PROCEDURE, TEKPOINT TOTAL
  515. K181709Serenity Piezo Sensor, Serenity Thermocouple Sensor
  516. K863729OPHTHALMIC FITLER MICRO CAPSULE
  517. K06131236MM BIOLOX DELTA CERAMIC HEADS
  518. K991391PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
  519. K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine…
  520. K253390SOMNUM (SOMNUM)
  521. K892153PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS)
  522. K860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
  523. K042525CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY…
  524. K905722SUTURE APPLIER DEVICE
  525. K781406HYDRON BURN BANDAGE MANUAL APPLICATION
  526. K070708OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
  527. K860295FETASCAN 1500
  528. BK220753System, Test, Automated Blood Grouping and Antibody
  529. K912844KODAK EKTACHEM DTII SYSTEM
  530. K061064COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
  531. K974876BIONX DISTAL RADIUS SCREW
  532. K770982UNITED SKIN BARRIER
  533. K812717NON-STERILE SHADOW-STRIPE CATHETER
  534. K960873MODEL 1210, MEDIUM E-NET
  535. K821383ECHO, MODEL MM-1000
  536. K991590C-LEG (3C100)
  537. K942579FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22
  538. K851110GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.
  539. K083103ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
  540. K872747LASER CENTERING DEVICE
  541. K082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
  542. K862524DEKNATEL (R) TREPHINE
  543. K181614Sterling Supreme Diode Laser
  544. K823305DENTO SPRAY ORAL IRRIGATOR
  545. K112118DREAMBOND
  546. K851275GIBCO MYCOTECT 189-5670
  547. K052335ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
  548. K920336MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
  549. K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
  550. K905074MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
  551. K940610AUROLITE 9
  552. K901848GADOLINIUM-153 BONE DENSITOMETER SOURCES
  553. K201198S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
  554. K190683External Counterpulsation System
  555. K770439STOMA BAG W/SKIN BARRIER SEAL RING
  556. K131935ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
  557. K013266RUSCH POLYFLEX STENT KIT
  558. K203701Locator Overdenture Implant System
  559. K983439ABBOTT ARCHITECT FREE T3
  560. K791708INORGANIC PHOSPHORUS REAGENT
  561. K895811SHARGHP HYPODERMIC NEEDLE
  562. K200525Medical Diode Laser Hair Removal System
  563. K033281DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
  564. K964397THERAPIK
  565. K162524AZUR CX Detachable 18 Peripheral Coil System
  566. K183034MOSAIQ Oncology Information System
  567. K083118SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
  568. K860212CARDIOFAX ECG-6353
  569. K171528Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
  570. K983830COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
  571. K150716Varaya Sport
  572. K152661HICAT Air
  573. K882092CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
  574. K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
  575. K040725BD FACSCANTO SYSTEM
  576. K250845Curiteva Porous PEEK Standalone ALIF System
  577. K772049WALKING AID
  578. K820059RESUSCITATION MASK
  579. K203064ICU Health Surgical Mask
  580. K970579ONE STEP MORPHINE CARD TEST
  581. K963910HEART NEBULIZER #100609
  582. K132558SYNC-RX SYSTEM
  583. K941535TRACHEOLIFE
  584. K862399BIOTIS SXT AGAR
  585. K143310MoisturemeterD
  586. K951889LYFO(TM) DIFFERENTIAL DISK
  587. K251133AVEA disposable expiratory filter/water trap (11790)
  588. K972122DREAM CATCHER
  589. K190168Aquas Probes
  590. K090069PROCERA IMPLANT BRIDGE OVERDENTURE
  591. K871066CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
  592. K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
  593. K030618WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
  594. K883383LIFEGUARD VENT MASK
  595. K220048NobelProcera Zirconia N1 Base
  596. K110005SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
  597. K950562IMPLANTABLE STAPLE
  598. K061483VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
  599. K920690NOROTRACK 360 INCLINOMETER
  600. K770008MPX 125
  601. K940593DISPOSABLE MICROSTAAR INJECTOR
  602. K810699PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM
  603. K213983Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
  604. K960950FRANCO SORDELLI SUNGLASSES
  605. K851080GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE
  606. K792511HELENA FACTOR VII DEFICIENT SUB. PLASMA
  607. K864182ENTERAL ADMINISTRATION ADAPTERS
  608. K792237HEARING AID, UNITRON MODEL 905W
  609. K802527TEST KIT FOR DETECTION OF ANTINUCLEAR
  610. K161272Supreme and Response Electrophysiology Catheters
  611. K881689LINDLEY II RESUSCITATOR
  612. K182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
  613. K900307KARE CHAIR I
  614. K963872FEMRX MORCELLATOR SYSTEM
  615. K930931NASAL/PARANASAL ENDOSCOPE
  616. K972082CUSTOM NASAL SPLINT
  617. K002449BIOTEQ I.V. (INTRAVENOUS) SET
  618. K842408IREX 730 MECHANICAL SECTOR SCANNER
  619. K101744THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
  620. K103292TRIO TRAUMA SPINAL SYSTEM
  621. K942864LUNG DIFFUSION
  622. K063861GS SYSTEM
  623. K810615CORNING 925 CHLORIDE METER
  624. K132229OMNI PATENT MONITORS
  625. K900590BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
  626. K811933GUARDIAN, VOLUMETRIC CONTROL DELIVERY
  627. K924892FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
  628. K232380t:slim X2 Insulin Pump with Interoperable Technology
  629. K873444ENTECH ENTERAL PUMP AND SET
  630. K141904VIORA V-TOUCH
  631. K130648FORUM GLAUCOMA WORKPLACE
  632. K152283MAGNETOM Amira
  633. K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
  634. K952224STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
  635. K060143LNCS AND SPO2.COM SENSORS
  636. K100597HARMONIC FOCUS SHEARS
  637. K111518STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
  638. K213891RealNow
  639. K922649ACE BASIC DENTAL IMPLANT PACK II
  640. K781709SCANNER, LINEAR
  641. K201520The Alma Opus System, Colibri Applicator and Tips
  642. K182790Cardio-TriTest v6.5
  643. K143385Acumed Ankle Plating System
  644. K092041STELLAR FIDUCIAL MARKER, MODEL GFMIA
  645. K851383BLISTERFILM TRANSPARENT DRESSING
  646. K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer…
  647. K912890MODEL SONICAID AXIS
  648. K770665VALVE, PRESSURE, DEMAND
  649. K020079BLADEWORKS MICROKERATOME BLADE, MODEL 7061
  650. K060084LYSUS INFUSION SYSTEM
  651. K922888ONE TOUCH IIB BLOOD GLUCOSE METER
  652. K153397S-Wire Guidewire System
  653. K891508PATIENT EXAMINATION GLOVES (LATEX)
  654. K080979STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
  655. K230248VIOLA
  656. K133340SPINEWORKS ANTERIOR LUMBAR DEVICE
  657. K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
  658. K040415PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS…
  659. K904907ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
  660. K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
  661. K800025DINAMAP RESEARCH MONITOR 1245
  662. K860153OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
  663. K952243EXTENSION SET/I.V. SET
  664. K072695VITEK 2 GRAM POSITIVE TIGECYCLINE
  665. K042866AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
  666. K191374Revival Modular Hip Stem
  667. K023493PK ZIP WING CUTTING DISSECTOR
  668. K885184SHAW SUN SYSTEMS MODEL 2400
  669. K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
  670. K840593DISPOSA-SPEC
  671. K915482B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
  672. K853878ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
  673. K842746HYCEL ROTOR-MIXER AND/OR MULTI
  674. K211781Disposable Nitrile Gloves
  675. K970503DEPUY ACE TROCHANTERIC SIDE PLATE
  676. K082789G1B PULSE OXIMETER
  677. K921179OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20
  678. K951626SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
  679. BK180247Test, Donor, CMV
  680. K832580RAAF CATHETER REPAIR KIT
  681. K873530PARAMAX MAGNESIUM REAGENT
  682. K011308MULTISTIM
  683. K893939ISOLATION MASKS
  684. K812048IDS RAPIDS NH SYSTEMS
  685. K781457FOLEY CATHETERS
  686. K760655ANEROID SPHYGMOMANOMETER
  687. K870962GESCO ASPIRATOR
  688. K954294HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
  689. K151894IPS Ivocolor
  690. K993423BACT/ALERT SA
  691. K161654NuFACE Gel Primer
  692. K233143PiXel8-Reveal
  693. K896427SPACELABS' MODEL 90514, MULTIGAS ANALYZER
  694. K092962CAROTID COIL 5000004901
  695. K993319VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
  696. K944715W&H 795 TOP AIR TURBINE SINGLE SPRAY
  697. K003413ALUMINA V40 HEAD
  698. K213475Elevo Snoring Intervention Set
  699. K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
  700. K212415Arthrex Modular Glenoid System-Titanium Glenosphere
  701. K950959TROCAR SUPRAPUBIC, NON-DISPOSABLE TROCAR, DISPOSABLE
  702. K042952VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE
  703. BK120015Counter, Differential Cell
  704. K062853MODIFICATION TO STRYKER SPINE OASYS SYSTEM
  705. K972492BELL PROSTHESIS (PARTIAL)
  706. K943991O-R-EZ TIP CLEANER
  707. K012552SCITON IMAGE HAIR REMOVAL LASER
  708. K012424SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
  709. K896116ENTRAPPING FILTER
  710. K180075MINUET LCD, MINUET LCD eco
  711. K895933ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III
  712. K261061BP Go (BPP-855)
  713. K960501ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
  714. K896428SEMPERMED LATEX EXAMINATION GLOVES
  715. K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP…
  716. K201619EndoTool IV System
  717. K193063EMBOTRAP III Revascularization Device
  718. K133629ANGIOJET ULTRA AVX THROMBECTOMY SET
  719. K822372OFFICE ECONO-FORCEPS
  720. K021171Q-STRESS ECHO BED
  721. K123959CIRCUFLOW 5150
  722. K260076SAM 3.0 Multi-Hour Continuous Ultrasound Device
  723. K780978SINGLE USE ACTIVE ELECTRODE HANDLE
  724. K132140DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
  725. K140186THE STORK OTC
  726. K120554ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC…
  727. K023872VITALCARE URETHRAL CATHETER RED RUBBER
  728. K943176KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
  729. K112501VENUS PEARL PLT REFILL A1
  730. K162264Cascadia Interbody System
  731. K172585Liberty Anterior Cervical Plate
  732. K131100STREAMLINE TL SPINAL SYSTEM
  733. K935841DR KOOL
  734. K844932MALT AGAR
  735. K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle
  736. K895583ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
  737. K252802Peak Flow Meter (PF-10(BR-PEF231))
  738. K844841KALOS-04 PULSE GENERATOR
  739. K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
  740. K993751COROMETRICS MODEL 173 FETAL MONITOR
  741. K142939Revolution Spinal Fixation System
  742. K872981ACS INDEFLATOR PLUS (MODIFICATION #2)
  743. K930732DELFIA CORTISOL KIT
  744. BK920024Media, Potentiating for In Vitro Diagnostic Use
  745. K780393BIOSTATOR GLUCOSE ANALYZER
  746. K843758UROPAPER EIKEN GK
  747. K022339TOTAL BILIRUBIN
  748. K981231CO2
  749. K042017BAHA DIVINO
  750. K102080DEPUY RECLAIM REVISION HIP SYSTEM
  751. K821409CORPAK-ENTERAL FEEDING CONTAINER
  752. K012922ULTRAFLEX EV HEMOSTASIS INTRODUCER
  753. K192443Dextile Anatomical Mesh
  754. K911052NEXUS(TM) FEMORAL HIP STEM
  755. K201577MatriDerm
  756. K791593BRILLIANT GREEN AGAR
  757. K972420LORENZ PECTUS SUPPORT BAR
  758. K202071SURGIPHOR Wound Irrigation System
  759. K803055ELECTROSURGICAL TIP CLEANER & HOLDER
  760. K843582MULTI-FORMAT FILM CAMERA
  761. K021469MINOLTA PULSOX-2
  762. K771112AUTO SUTURE R CLIP
  763. K10234831P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL…
  764. K033076LIFESTYLES LIQUID PERSONAL LUBRICANT
  765. K910067PTI STERNAL CLOSURE WIRE SUTURE
  766. K152498SoloPath Re-Collapsible Access System
  767. K993513DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
  768. K870062BICARBONATE PROCEDURE
  769. K091367GDS-DCS
  770. K070355FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY
  771. K880623MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP
  772. K251578BEAUTIFIL II
  773. K862709MECHANICAL CYSTITOME
  774. K921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
  775. K953720AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
  776. K842343SABA-COOMBS MINI EXTERNAL FIXATOR
  777. K081466STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
  778. K901717KLEIN MICRO-CANNULA(TM)
  779. K915317PUTMAN STABILIZER
  780. K850198FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG
  781. K071993T-PORT HP INFUSION PORT
  782. K231857Arthrex TightRope II
  783. K960523NHMC DRESSING TRAY
  784. K790123STIMULATOR, BATTERY POWERED
  785. K842216CULTURESET HSV ISOLATION & ID SYS
  786. K213466Houdini Cross Support Catheter
  787. K223662Neodent Implant System - Helix Short Surgical Kit Cases
  788. BK040024System, Test, Automated Blood Grouping and Antibody
  789. K081853OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
  790. K233903Zeta Cranial Navigation System (ZNS131-US)
  791. K212149MyndMove 2.0
  792. K905779ALDETECT
  793. K925250KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS
  794. K223535SMARTbase Abutment System
  795. K810724CORNING 178 BLOOD GAS ANALYZER
  796. K223843FloPatch FP120
  797. K190704Signature Ceramic Femoral Head
  798. K904671QAR HANDPIECE
  799. K021927PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
  800. K161331HyperSound Tinnitus Module
  801. K221572VyPlate Anterior Cervical Plate System
  802. K780230BED BOARD
  803. K851421S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP
  804. K853763TENDON STRIPPER
  805. K162641Smith & Nephew, Inc. R3™ Constrained Liner
  806. K213514Spectricept Skin and Wound Cleanser
  807. K954187TRIGLYCERIDES REAGENT
  808. K840311CAT. 7-EAR, NOSE & THROAT DEVICES
  809. K230540Patient Specific Planning Solution™ 3D Bone Models
  810. K851933CLINICAL CHEMISTRY ANALYTICAL SYSTEM
  811. K914190AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
  812. K030213ONLINE DAT II CANNABINOIDS II
  813. K860240CNS-EP SYSTEM AND EP 1.0 SOFTWARE
  814. K960787TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
  815. K192517Psychemedics Microplate EIA for Cotinine in Hair
  816. K010710SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
  817. K071851HDC STERILE SPIDER SCREW
  818. K090918NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER
  819. K981985ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
  820. K023117PRIMAGARD SURGICAL GOWNS
  821. K032137PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
  822. K230633APOLLO ADVANTAGE Nitrile Examination Gloves
  823. K945240IRMA BLOOD ANALYSIS SYSTEM
  824. K062541CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
  825. K141149VITEK 2 AST GP CEFTAROLINE
  826. K831672SPECTRUM-10
  827. K864396LYMPHOCYTE MAINTENANCE MEDIUM
  828. K022190MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
  829. K161946DoseCHECK
  830. K132251APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
  831. K102737KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
  832. K883499MEDIUM 199, 10X, CATALOG NO. 210-3557
  833. K073152PC-180 / PRINCE 180 EASY ECG MONITOR
  834. K103693VANTAGE ABI
  835. K822435MEDI-THERM SKIN THERMOMETER
  836. K021948LUCIUS 62
  837. K821578VENOSET DUAL-RATE PIGGYBACK W/IVEX &
  838. K000678RAEBBITT/EVOLUTION POWERED WHEELCHAIR
  839. K082496PACSMATE MMD-3213M MONITOR
  840. K993099BREMER HALO SYSTEM TITANIUM SKULL PIN
  841. K780305CELL
  842. K241049CANON Fundus Camera CR-10 (CR-10)
  843. K210546Elecsys proBNP II, Elecsys proBNP II STAT
  844. K102065SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
  845. K953428CHAMPION, 3000
  846. K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
  847. K991345ASP-100, MODEL 2100
  848. K830970DOUBLE LUMEN TRANSFER DEVICE
  849. K971582NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET
  850. K833307PHADEBACK G.C. POSITIVE CONTROLS
  851. K933643WIDEX MODEL LOGO 6 (L6)
  852. K921499SEAL RING FOR NASAL CPAP
  853. K854514AMBI-24 PH/PRESSURE MONITOR
  854. K934975TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER
  855. K891203SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
  856. K945179BOTTLE COLLECTION SET
  857. K033631MODIFICATION TO COATEST FACTOR VIII
  858. K760983ENDODONTIC INSTRUMENTS
  859. K884090LUNDY VAPORIZER SYSTEM
  860. K060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
  861. K760644NECKSAVER
  862. K133355CADWELL FLEX EEG/PSG
  863. K925381ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
  864. K922042CARDIFIX ENDOCARDIAL PACING LEAD
  865. K940233NEOSCREEN ELISA HYDROXYPROGESTERONE
  866. K771685AMPLIFIER MODEL N5A-HIS
  867. K854001CERTI-FORM
  868. K051996DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30
  869. K112448PULSIOFLEX
  870. K120589MILAGRO INTERFERENCE SCREWS
  871. K260138LUNE PureHygiene
  872. K931973DISPOSABLE PEEL-AWAY INTRODUCER SHEATH
  873. K983717BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
  874. K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
  875. K945158MICRO-TOUCH LP LATEX SURGICAL GLOVES
  876. K971652P.F.C. SIGMA INSET PATELLA
  877. K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
  878. K023787TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
  879. K091113MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
  880. K921207DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION
  881. K250788Definium Tempo Select
  882. K091260SERAQUEST EBV EA-D IGG TEST
  883. K901934KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
  884. K770623CONDUCTIVE CREAM-500
  885. K874653STERILE SURGICAL SCRUB BRUSH
  886. K071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
  887. K980004MANAN GENERAL PURPOSE INTRODUCER NEEDLE
  888. K941986CUTANEOUS ELECTRODE
  889. K033989MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69
  890. K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
  891. K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
  892. K781353PAPILLOTOME CUTTING SNARE
  893. K834029BIO-UREA
  894. K261045Verifine Safety Lancets
  895. K200910BOSS Balloon Guide Catheter
  896. K061107DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
  897. K771601X-RAY REMOTE CONTROL TABLE
  898. K002591COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
  899. K020456EASI 12 LEAD ALGORITHM
  900. K962918LIDCO SYSTEM
  901. K8517282250/1 TO 2285/2 VARIOUS COTTON TWEEZERS
  902. K843826COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
  903. K940003VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
  904. K973597AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
  905. K073621INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE…
  906. K821690ERIKA HPF 100,200,300 DIALYZER
  907. K9248123M CURING LIGHT XL 3000
  908. K93037825 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441
  909. K771700TMA BICARBONATE/GLYCEROL DILUENT
  910. K892788PATIENT EXAMINATION GLOVES (LATEX)
  911. K003242LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
  912. K012510MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
  913. K931366TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3
  914. K913531PATIENT EXAMINATION GLOVEWS
  915. K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC…
  916. K003538TDP CQ-27 HEAT LAMP
  917. K880794RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
  918. K220098Digital Radiography CXDI-Pro, Digital Radiography D1
  919. K023832SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
  920. K011318VENODYNE DVT ADVANTAGE PLUS
  921. K024174NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
  922. K210917Single Use Injection Needle
  923. K895856MEDISYSTEMS TRANSDUCER PROTECTOR
  924. K892207FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED
  925. K032204MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
  926. K051782BLUEPHASE 16I
  927. K853457COBURN I/A SYSTEM
  928. K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava…
  929. K163168Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination…
  930. K012178FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA…
  931. K883551SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325
  932. K073411LITEDUO
  933. K853054RF CARD TEST
  934. K854113CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
  935. K200817URIS OMNI Narrow System & Prosthetic
  936. K844077NUTRIMIX EMPTY CONTAINER
  937. K072068BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN…
  938. K231669Ziehm Solo FD
  939. K974482SILIMED GLUTEAL IMPLANT
  940. K950802LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM
  941. K981943DBIL
  942. K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius…
  943. K955339HYDROLOGY 5000
  944. K113132DISPOSABLE HEMOSTATIC Y-CONNECTORS
  945. K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…
  946. K981142MAICO MA53
  947. K010636FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES…
  948. K905048ACE 3.5MM CORTICAL BONE SCREW
  949. K972963MODIFIED CEDIA DAU PCP ASSAY
  950. K943056SINGLE STICK RADIALLY EXPANDING DILATOR
  951. K042724MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
  952. K191592CalprestNG, EasyCal
  953. K922364DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
  954. K042261MACROPORE PURICEL LIPOPLASTY SYSTEM
  955. K952355THE HILL ADJUSTABLE 90MD
  956. K131930JBAIDS ANTHRAX DETECTION KIT
  957. K792723BLOOD FLUID FILTERS
  958. K870436LOOK IRRIGATING/ASPIRATING CANNULAS
  959. K171726LapBag
  960. K864232ROTATION AIR FLUIDIZED BED/DELTA
  961. K260761APTUS Clavicle System 2.8
  962. K990198AMIB7
  963. K150291TYRX Neuro Absorbable Antibacterial Envelope
  964. K954466PROFORM POROUS BEADED FEMORAL STEM
  965. K111986LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
  966. K160698LigaPASS
  967. K842950SUPER MAXITHINS BODY-SHAPED MAXI PADS
  968. K050921EASYSTIM NMS-28
  969. K823833MICRO STIX #011-010-5000 & HOLDER#5100
  970. K925130NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)
  971. K153392STERIZONE VP4 Sterilizer
  972. K904162CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES
  973. K022699TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
  974. K994334ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
  975. K770447EPC INSTICKS
  976. K900702MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
  977. K993345K-ASSAY APO AI
  978. K892986PATIENT EXAMINATION GLOVE
  979. K963962VISTA BRITE TIP CATHETERS
  980. K112064RESORB X-G
  981. K791993SKIL-CARE BED RAIL PADS
  982. K010677XPS 3000 SYSTEM
  983. K881263MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
  984. K991879SPRING-WOUND EPIDURAL CATHETER
  985. K800203RIA PHASE T4
  986. K962474OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
  987. K923690MINI HEART
  988. K870520TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
  989. K200241TempSure System
  990. K780157RADIATION TREATMENT PLANNING SYSTEM
  991. K961176OMNI COLD GEL PACKS
  992. K211480NubeX
  993. K083931SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
  994. K852860MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE
  995. K243677iovera° System
  996. K963112MMG MULTI LUMON EXTENSION SET
  997. K130293ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
  998. K210385cobas Cdiff nucleic acid test for use on the cobas Liat System
  999. K833401OMYL -ARDE- SPECTACLE FRAME
  1000. K915498CORDIS ANGIOGRAPHIC DOPPLER CATHER

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