Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K920579LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
  2. K972162ELECSYS CA 125 II
  3. K024017BAYER ADVIA CENTAUR HER-2/NEU ASSAY
  4. K880335INTRA II SECRET EAR HEARING AIDS ISE
  5. K924343WRIGHT POCKET PEAK FLOW METER
  6. K041094HSG CATHETER SET
  7. K160664Aqueduct 100 Cervical Dilator
  8. K053022SYNTHES (USA) CHRONOS-BETA-TCP
  9. K922597OLYMPUS UREA NITROGEN (BUN) REAGENT
  10. K061785CYL-FIL OXYGEN SYSTEM
  11. K911711KODAK AUTOMATIC FILM FEEDER, MODEL RA
  12. K892353PERRY* NON-STERILE X-AM* GLOVES
  13. K231202QuickRayPRO
  14. K781119ECA HEME BUFFER
  15. K812882RHEUMATEX
  16. K151396MIVI Mi-AXUS Guide Catheter
  17. K913193MODEL 100 CENTRAL STATION
  18. K990597SUMMER'S EVE LUBRICATING JELLY
  19. K002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
  20. K830625CYTO-STAIN
  21. K945156SLASE 210 PLUS HOLMIUM LASER SYSTEM
  22. K161330Pour Acrylic
  23. K070618DICOMPACS, MODEL 5
  24. K862048SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM
  25. K921014MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR
  26. K872955DELFIA(TM) FERRITIN KIT
  27. K103455SPECTRA LASER SYSTEM
  28. K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter…
  29. K093627IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
  30. K872313NEEDLE & BLADE COUNTER & DISPOSAL UNIT
  31. K881378PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
  32. K012934CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
  33. K053160MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
  34. K960455BIPOLAR SUCTION COAGULATOR
  35. K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
  36. K030857MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC…
  37. K890033MODEL 8700 PULSE OXIMETER
  38. K915407PHARMETRIX MEDIPUMP MODEL 524
  39. K253703RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
  40. K911807METERED DOSE INHALER (MDI) SPACER
  41. K112060RADIANCE
  42. K061465KMI CEMENT RESTRICTOR IMPLANT
  43. K952044INSULCAP
  44. K922742HPM 40 HEART PACEMAKER MONITOR
  45. K943253INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
  46. K050519ADVANCED TURBO DRIVE SYSTEM
  47. K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENT
  48. K141165MATRIXWAVE MMF SYSTEM
  49. K964366EAGLE EYES
  50. K131966TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
  51. K261826VSP System (Titanium Palatal Splint)
  52. K897115ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
  53. K812686SINUSCOPE
  54. K102916G-CATH TISSUE ANCHOR DELIVERY CATHETER
  55. K012105POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
  56. K813350NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
  57. K991701MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD…
  58. K902658GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES
  59. K083189STERI-LUB LUBRICATION GEL
  60. K073439TRANSITION STABILIZATION SYSTEM
  61. K932158CALCIUM TEST ITEM NUMBER 65409
  62. K850509ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM
  63. K141551PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES)…
  64. K926246OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
  65. K761056DISPLAY MONITOR (MODEL 78301A)
  66. K123169ORALID
  67. K203535Trinias
  68. K250189AdvaTx
  69. K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…
  70. K971492AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
  71. K234087restor3d TIDAL Lumbar Interbody Fusion System
  72. K855136FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE
  73. K031569DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
  74. K840954DYNAMIC CONDYLAR SCREW OR D.C.S.
  75. K884003GONIOMETER AND BIOMEDICAL RECORDER SYSTEM
  76. K935802SELECT(R) SHOULDER ALL POLY GLENOID
  77. K840122IURA AMBULANCE STRETCHER IAS-1
  78. K920213MITEK ANCHOR, MITEK ANCHOR II
  79. K895802NON CONSTRAINED TOTAL SHOULDER SYSTEM
  80. K021602FOSSA URETERAL STONE SWEEPER
  81. K150266Remington Medical Inc. Tuohy Epidural Needles
  82. K992802TERUMO U-100 INSULIN SYRINGE
  83. K770647ELECTROSURGICAL GROUNDING CABLE
  84. K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
  85. K243065Cardiac Guidance
  86. K822096CHEMOTHERAPY INFUSION CATHETER
  87. K063512LEKSELL GAMMA KNIFE PERFEXION
  88. K772038KANAMYCIN RIA
  89. K223706PMMA BLOCK
  90. K072558CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
  91. K820291KNEE SUPPORT FOR X-RAY & SURGERY
  92. K880393TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE
  93. K190456BTL 799-2L
  94. K972396VISTA ANTIGEN BRUCELLA MELITENSIS
  95. K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
  96. K902083CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
  97. K980757ILAB 600 CLINICAL CHEMISTRY SYSTEM
  98. K781700IONOTPHORETIC APPLICATOR
  99. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail…
  100. K974577COMPOGLASS FLOW
  101. K042821DIGITAL DETECTOR, MODEL GR17
  102. K980906TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
  103. K894937SHAW KNEE MODULAR TIBIAL TRAY-POROUS
  104. K790958120 WELL HISTO-PLATE
  105. K024300MICROCAP PLUS/NPB-75
  106. K091071NUVASIVE LATERAL PLATE SYSTEM
  107. K190724MD-Temp Plus
  108. K050764UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
  109. K150880Tablo Console with Wireless Capability
  110. K160315I4 (Integrated Intelligent Imaging Informatics) system
  111. K180419Ultrasonic Doppler (Model YM-2T8)
  112. K161860TG-970P CO2 Sensor Kit
  113. K060875ABBOTT AXSYM TROPONIN-I ADV
  114. K021786TITANIUM ANKLE ARTHRODESIS NAIL
  115. K911208TIN COATED DENTAL BURS
  116. K840563RX C & B 20
  117. K171642Atellica IM Ferritin Assay
  118. K940793DOUBLE TRACH SWIVEL CONNECTOR
  119. K861044MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND
  120. K881704EASY TENS
  121. K002772ASCENT XXL CLOSED BOX FEMORAL COMPONENT
  122. K923946CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER
  123. K011665BCT SYSTEM
  124. K926259SURGIMAT
  125. K961424INTRAN 500
  126. K872270ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP
  127. K1836753D Visualization System
  128. K070501RUIKE 3421 POWERED WHEELCHAIR
  129. K973381BIOROC EZ SUTURE BONE FASTENER
  130. K842296ISOSTATION LOWER BACK MACHINE
  131. K193040Resorbable Mesh Device
  132. K242029TRAP EASY
  133. K200770Mini PCNL-System
  134. K151533Respiratory Gating for Scanners
  135. K853187ACRIDINE ORANGE FLUORESCENT STAIN
  136. K830488VENTILATOR #1
  137. K221992Electronic Pulse Stimulator
  138. K941030DRIED GRAM-NEGATIVE CEFPODOXIME
  139. K000819PHILIPS CT SECURA MV
  140. K962668AMR-ACV CLAMPS
  141. K052723SEVEN STAR NEEDLE
  142. K961308AUDIO 'D' INTIMA CIC
  143. K811245OPHTHALMIC SCISSORS
  144. K013838KSEA CLEARVISION LENS IRRIGATION SYSTEM
  145. K895597VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
  146. K905104MODEL 3100-64: QUADRATURE SPINE COIL
  147. K070486CAPILLARYS URINE (PN 2012)
  148. K980400PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
  149. K873180BIOTROL MAGNESIUM CALMAGITE
  150. K870719SENSIR SYSTEM
  151. K090354LAMINOPLASTY PLATING SYSTEM
  152. K974870LATEX EXAMINATION GLOVE POWDER FREE
  153. K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
  154. K113459ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER…
  155. K233742CloudTMS Edge for OCD
  156. K923291NAICO WHEEL CHAIRS
  157. K894145EMIT T-UPTAKE ASSAY
  158. K901180FOLEY CATHETER INSERTION TRAY (30CC)
  159. K801685SPACELINE DENTAL CHAIR-UNIT
  160. K822557SPECIMEN ADAPTOR
  161. K945611PERITRON
  162. K882808RPMI-1640 MEDIUM, CATALOG NO. 200-2076
  163. K063788REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
  164. K260585Noxturnal Web
  165. K832329STERILE IV SET 4 SIZES
  166. K001748MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
  167. K002893FLUOROLAB PLUS
  168. K952490IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM
  169. K943071THE TITANIUM FIXATION SYSTEM
  170. K153070Watch-PAT200U
  171. K864721CRYOTHERM
  172. K791857HOLLOW FIBER DIALIZER MODEL TRIEX-3
  173. K801204EMIT DISOPYRAMIDE ASSAY
  174. K810839SPOTAR
  175. K994140NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
  176. K960397MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
  177. K843794LATEX-R RICKETTSII
  178. K9210513M PRECISE BRAND INTERNAL SURGICAL STAPLES
  179. K980771LYSONIX SUCTION LIPOPLASTY SYSTEM
  180. K902796LATEX EXAMINATION GLOVES
  181. K013465ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
  182. K990057SYNERGY ADJUSTABLE LENGTH ROD
  183. K052159AIDA COMPACT II SYSTEM
  184. K992120DYNAWELL OR DYNAWELL
  185. K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
  186. K061909HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
  187. K822024BACILLU S SUBTILIS BIOLOGICAL INDICA.
  188. K121252HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
  189. K932753ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
  190. K113797DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
  191. K923789MAYFIELD ADULT DISPOSABLE SKULL PIN
  192. K912154QUALITONE MODEL 48 C-WR-BEHIND THE EAR
  193. BK880005Supplies, Blood-Bank
  194. K013061BIOTOUCH MASSAGE THERAPY SYSTEM
  195. K022709MEDLITE Q-SWITHCED LASER
  196. K070362SURFLO WINGED INFUSION SET
  197. K102479ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
  198. K923556ADP FACEMASK
  199. K770645SPECTROPHOTOMETER, MODEL 751
  200. K771519SPECIALIST ARM & LEG PROTECTOR
  201. K954536BLADE, SCALPEL & BLADE, HANDEL
  202. K132573VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
  203. K810825POLYVINYL SILICONE IMPRESSION MATERIAL
  204. K173360Athena 190
  205. K170023SPiN Thoracic Navigation System
  206. K782034INFUSION PUMP, MODEL AS*5
  207. K152156Opticage Expandable Interbody Fusion Device
  208. K143067Carnation Ambulatory Monitor
  209. K912590AVI MODEL 400D INFUSION PUMP
  210. K003479U-SYSTEMS ULTRASOUND SYSTEM USI-2000
  211. K182352SP-LINK™ System
  212. K012135POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS…
  213. K954367ARGISTAR BIO 75PF
  214. K211562Virtue RF
  215. K892215UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
  216. K790375TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
  217. K864744CREATINE PHOSPHOKINASE (CK)
  218. BK060004Blood Bank Supplies
  219. K811740KALLESTAD'S ENDOPLATE FACTOR B TEST
  220. K962492SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
  221. K013096PHENCYCLIDINE
  222. K834071LYMPHANGIOGRAPHY SET SPECIAL 30G
  223. K981580HDL
  224. K141091RAYSERT PLUS INJECTOR
  225. K971546SOMA 900 TRANSPORT BED
  226. K802441CLIRANS TH10 HOLLOW FIBER DIALYZER
  227. K991380OIL FOR TISSUE CULTURE
  228. K901018MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
  229. K871475SOLOLIFT - PATIENT TRANSFER STRETCHER
  230. K193553VarseoSmile Temp
  231. K021077MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
  232. K943430CERVICAL FUNCTION INDICATOR
  233. K926508INTRASITE GEL
  234. K943936XLT, REA COMFORT, SPIREA, ZOOM
  235. K854912ANGIOMED GUIED WIRES
  236. K143191IntelliSense Drill
  237. K954119MIRACLE EAR MIRAGE
  238. K150627Rapid Aid Instant Disposable Infant Heel Warmer
  239. K864534ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
  240. K153591ebb Complete Tamponade System
  241. K001111PANORET, MODEL 1000A
  242. K915514DENTA SAFE LATEX EXAMINATION GLOVES
  243. K222002Persyst 15 EEG Review and Analysis Software
  244. K121669WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
  245. K894933PERLIDENT
  246. K955683RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
  247. K960828POS-T-VAC B-10 BAND KIT
  248. K172201Atellica IM Folate Assay
  249. K904005HUESTIS FLEXI-BOARD
  250. K212064Orchid Safety Release Valve(TM)
  251. K932342MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER
  252. K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
  253. K780794IRRIGATION CAP
  254. K121437MINI MAXLOCK EXTREME PLATING SYSTEM
  255. K090409BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
  256. K864040BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
  257. K973275KLS-MARTIN INTRAORAL DISTRACTOR
  258. K261856Halcyon, Ethos Radiotherapy System (5.0)
  259. K982062CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
  260. K071763AMADEUS ADAPTIVE COMPRESSION THERAPY
  261. K871979GAMMA GLUTAMYLTRANSFERASE REAGENT
  262. K923672COX DISPOSABLE ENDOSCOPE CLEANING BRUSH
  263. K931408SUNGLASSES
  264. K862133HYGEIA RAPID STREP A TEST
  265. K120619ORTHODONTIC FLOWABLE BRACKET ADHESIVE
  266. K843062TBM-REAGENT FOR T,B CELL & MONOCYTES
  267. K021753E-CARE INFARED EAR THERMOMETER, MODEL LCT-200
  268. K982050MODEL MS-2 HANDPIECE
  269. K861147UCS-2, ULTRASONIC CLEANING SOLUTION
  270. K062661AEQUALIS RESURFACING HEAD
  271. K791418VASCULIZER
  272. K990427ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
  273. K894179COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY
  274. K022232CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
  275. K990013EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
  276. K030748AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
  277. K944407OLYMPUS MAGNESIUM REAGENT
  278. K080307PROCHEM INDICATOR TAPE
  279. K233691FlexCath Cross Transseptal Solution
  280. K040655SWIFT ANTERIOR CERVICAL PLATE SYSTEM
  281. K080697SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
  282. K933995TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION
  283. K781411CORNEAL CUTTER AND ACCESSORIES
  284. K003800AML HIP PROSTHESIS
  285. K802136DELTA TEST TRIGLYCERIDES
  286. K890355DENTAL X-RAY BITE BLOCK
  287. K973757D.O.R.C. SOLUX LIGHT SOURCE
  288. K994177SUTRASILK SILK SUTURE
  289. K021030TITANIUM CANNULATED INTERFERENCE SCREW
  290. K781314THERAPY UNIT & ELECTRODIAG.
  291. K780371TILT TYPE AC POWERED HOSPITAL BED
  292. K953468SONOGEL
  293. K110299DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES
  294. K940894MAGNA SL
  295. K090688COOK UROLOGICAL GRAFT
  296. K153248PEEK Customized Cranial Implant
  297. K942392AIRWAY CONNECTOR WITH FLEX TUBE
  298. K191257Erchonia EVRL
  299. K013946FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
  300. K012321POINT 4 FLOWABLE
  301. K921746VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
  302. K844529BRAIN HEART INFUSION BROTH
  303. K033748TRIDENT RESECTION ABLATOR
  304. K123141ENSEAL TRIO TISSUE SEALING DEVICE
  305. K914140GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED
  306. K061196CARDIOIMMUNE XL CARDIAC MARKER CONTROL
  307. K950942CRIT-LINE HEMATOCRIT ALERT
  308. K012647TONOPORT V
  309. K233470DEKA LILY
  310. K172309Endoscopic Ultrasound Aspiration Needle
  311. K931116IL TEST(TM) TRIGLYCERIDE
  312. K242119INNOVISION-EXII
  313. K964806MD-1835
  314. K012428MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
  315. K013592EXTREMITY COIL
  316. K021767ASSUFIL
  317. K160254GORE DrySeal Flex Introducer Sheath
  318. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
  319. K121623BIPAP A 40 VENTILATORY SUPPORT SYSTEM
  320. K991674CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS…
  321. K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
  322. K163013Quantib Brain 1.2
  323. K121227MANUKA FILL
  324. K160019U80 Series Upper Arm Electronic Blood Pressure Monitor
  325. K950853OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
  326. K911950MEDI GUARD DRAPES
  327. K211407Belun Ring BLR-100X
  328. K942162SIGMA 8000 AND SIGMA 8002
  329. K964696SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
  330. K802172URIHESIVE SYSTEM
  331. K843957ULTRATHIN/SP LENS
  332. K982087ROCHE CRP T CONTROL N
  333. K921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
  334. K895044DUAL GUIDE INTRODUCER CATHETER
  335. K053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
  336. K841697HYDRO-THERO PAD
  337. K821906CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP
  338. K823114BRACE-UP STOCKING KNEE BRACE
  339. K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
  340. K896216HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
  341. K940631CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
  342. K833956DOT VISUAL ACVITY TEST 2000
  343. K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako…
  344. K972061TOA
  345. K123345DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
  346. K053566MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
  347. K121287HT-WEDGE
  348. K993055DEXIDE BIPOLAR FORCEPS II** DEVICE
  349. K864778MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC
  350. K813586DIALYSIS CONCENTRATE
  351. K142273EmboGuide
  352. K951725OSTEONICS SPINAL SYSTEM
  353. K092957VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
  354. K150861QBit Series Diagnostic Ultrasound System
  355. K933354HOBBS MEDICAL CLEANING BRUSH
  356. K837081MICROSCAN 771 MANIPULATOR
  357. K863054AST S.C.E. (GOT)
  358. K000011MODIFIED HYDROPHILIC COATED GUIDEWIRE
  359. K896928FILPOST
  360. K944927NORELCO CLEAN AIR SYSTEM CAS900
  361. K940459MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
  362. K992027KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE…
  363. K901409TRANSDUCER PROTECTOR
  364. K051507MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
  365. K003374FERMIT PLUS
  366. K073719ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE
  367. K790746THE BIONIC EXERCISER
  368. K140492NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
  369. K071066SPYCATCH STONE RETRIEVAL BASKET
  370. K091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
  371. K043598FC 1400 FETAL MONITOR
  372. K001681POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
  373. K924571MEDI-SOL
  374. K111076SOLANAS AVALON POSTERIOR FIXATION SYSTEM
  375. K111611ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
  376. K801010KIRSCHNER WIRE
  377. K860402BIOTIS BISMUTH SULFITE AGAR
  378. K993651O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
  379. K002451MODIFICATION TO: PRONTO DRY
  380. K962515KERR ADVANCED ADHESIVE
  381. K761070P.S.M. SURGICAL HOOD
  382. K170195QuantX
  383. K030949TITAN HIGH RESOLUTION ULTRASOUND SYSTEM
  384. K073053COLPO-MASTER
  385. K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
  386. K891889OLIVECORONA SCISSORS
  387. K201526TIPCAM1 Rubina Video Endoscope System
  388. K083069EZLASE 10W
  389. K874336PATTERN DISCRIMINATION PERIMETER
  390. K082456VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
  391. K040028CA-1500
  392. K100883CARRIGEN
  393. K143080FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
  394. K050573NEUROLAC NERVE GUIDE
  395. K801749BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
  396. K001917PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
  397. K023394UNISIGHT SYSTEM WITH UNIGATE
  398. K791551HI-M-TEST MORPHINE
  399. K022033STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION…
  400. K771586CHOLOPAP-HDL
  401. K800716ORTHOTIC LEG GAIT CORRECTOR DEVICE
  402. K944141COMFIT (STERILE)
  403. K131278MONTERIS MEDICAL NEUROBLATE SYSTEM
  404. K884276BECKMAN KAPPA LIGHT CHAIN REAGENT
  405. K193066Steripack cases and Tray Systems
  406. K103242REDSENSE-ALARM UNIT AND SENSOR
  407. K761179PSORALITE
  408. K211363Medical Face Mask
  409. K021922MODIFICATION TO PARA 5X
  410. K232118ANDORATE® Valve Kit
  411. K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…
  412. K032527HEDROCEL VERTEBRAL BODY REPLACEMENT
  413. K014157HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
  414. K153042TRYPTIK2C-plate Anterior Cervical Plate System
  415. BK070004System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
  416. K160007Paclitaxel Sets
  417. K840006KINETIC LDH, A< BLUE 610 METHOD
  418. K013810CARDIOVASCULAR ARRAY
  419. K961192IRRIGATION SYSTEM
  420. K840916DIETO CONTAINER FOR ENTERNAL NUTRIT
  421. K171279Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and…
  422. K020932DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
  423. K030117ENHANCE SPERM FREEZE
  424. K943917CAPIOX ARTERIAL FILTER
  425. K012804PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
  426. K993835PARAPOST SYSTEM STERILIZABLE ORGANIZER
  427. K820747MONOJECT SAF-T-LOCK
  428. K760905SUPERMAX AUTOMATIC X-RAY PROCESSOR
  429. K934623ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
  430. K854170I.S.M. PRODUCT FAMILY MODEL R3600C
  431. K926175K-DEFIB/PACE CARBON ELECTRODE
  432. K827914NIIC CO2 LASER SYSTEM MODEL 3OZ.
  433. K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)
  434. K931900COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.
  435. K202298Lucent XP, Lucent XP Curved
  436. K772314WEDGES, RETAINING, MATRIX
  437. K863714BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES
  438. K062181C-JAWS CERVICAL COMPRESSIVE MINI FRAME
  439. K904997ABUSCREEN ONLINE TM FOR OPIATES
  440. K191103Parkell Desensitizer Gel
  441. K905614JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
  442. K841790LIFESCAN EEG MONITOR
  443. K052164MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
  444. K113247ANESTHESIA INJECTION TOOL SET
  445. K972978VISTA BRITE TIP GUIDING CATHETERS
  446. K864374ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
  447. K030362SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
  448. K833779YTTRO FILTER
  449. K895952TRIGLYCERIDES TEST KIT
  450. K070023MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
  451. K210676XSTAT 30 Pouch
  452. K984289VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA…
  453. K081520SENSITITRE VIZION
  454. K111608SLIC SCREW REPAIR SYSTEM
  455. K003920CORDIS M3 PTA DILATATION CATHETER
  456. K893000GLOBE PATIENT EXAMINATION GLOVES
  457. K960469DETECT CYTOLOGY BRUSH II
  458. K915187CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
  459. K033209FUKUDA DENSHI MODEL FF SONIC UF-750XT
  460. K150751Cordelle II Sound Processor
  461. K802185ARTERIAL BLOOD SAMPLING KIT
  462. K062916CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
  463. K031948PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
  464. K143326T.A.G. Dental Implant System
  465. K832460TRIGLYCERIDE REAGENT-TRINDER-GPO
  466. K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
  467. K090147BLOOD MONITORING UNIT, MODEL BMU 40
  468. K051145CRITIVIEW
  469. K221762BoneMRI v1.4
  470. K802495CLOSTRIDIUM DIFFICILE AGAR BASE
  471. K013433TROJAN PASSION BERRY GEL
  472. K032114SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
  473. K943872COMMANDER MARK II HAIR REMOVAL SYSTEM
  474. K781814SULFATE, FIBRIQUIK PROTAMINE
  475. K962916HUA-XIA ACUPUNCTURE NEEDLES
  476. K022776NESS SYSTEM
  477. K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
  478. K173267MasterLoc Stem: Lateralized Plus
  479. K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
  480. K141707ULTRASKIN HYDROPHILIC GUIDE WIRE
  481. K982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
  482. K946085THIN-FILM CARDIAC GATING CABLE
  483. K945219HORMANN HEARING INSTRUMENTS
  484. K9142604240 DYNAMIC BP/HEART RATE MONITOR
  485. K780466EMIT CARBAMAZEPINE ASSAY
  486. K981047FRESH AIR
  487. K932263SOLOSITE DERMAL WOUND GEL
  488. K933083DW247 #2
  489. K0833642.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS…
  490. K882984MEDIUM 199, NO. 200-2035
  491. K242652Lunit INSIGHT DBT v1.1
  492. K250705Sonata Transcervical Fibroid Ablation System 2.2
  493. K874261IQ/QCA TOTAL BILIRUBIN
  494. K913674RECORD AND VERIFY MEVATRON ADAPTER
  495. K880549DIACYTE FIXATIVE SOLUTION
  496. K233747Concha Sol Hearing Aids (CL-1001)
  497. K141222NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
  498. K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…
  499. K901164NEUSTEIN LARYNGOSCOPE
  500. K131642RSH BILIARY STONE REMOVAL DEVICE
  501. K925190PYLORISCREEN
  502. K873792SEPACELL R-500 AND SEPACELL R-500A
  503. K901707FORTRESS COMMUTER FT (FOLDING TRANSPORT)
  504. K963469MITTENS
  505. K093884ROCHE FLUDI METHAMPHETAMINE
  506. K191501PALLAS 308/311 Solid-State UV Laser System
  507. K932755REFLECTION ACETABULAR COMPONENT
  508. BK120024Test, Qualitative, for HLA, Non-Diagnostic
  509. K992574OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS…
  510. K860179CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
  511. K122938FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
  512. K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable…
  513. K093815LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
  514. K872349INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
  515. K821298BACKHAUS CLAMP, 3 1/2
  516. K902159BIFLEX(TM) ANNULOPLASTY RING
  517. K811242DISPOSABLE STERILIZATION WRAP
  518. K150915SPINAUT-P
  519. K875014LABTICIAN RETINAL IMPLANTS
  520. K933471SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
  521. K770169BEESON AUTOMADDAK FEEDER
  522. K1521165.5 F Worley Advanced LVI Lateral Vein Introducer
  523. K061178ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
  524. K100024TECO DIAGNOSTICS UTI DETECTION STRIPS
  525. K954315PVC ABDOMINAL/RECTAL PRESSURE CATHETER
  526. K934462ADULT ANESTHESIA BREATHING CIRCUIT KITS
  527. K242930Natus BrainWatch System
  528. K082059ANGIOSCULPT PTA SCORING BALLOON CATHETER
  529. K873431PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
  530. K033979CORLINK AUTOMATED ANASTOMOTIC SYSTEM
  531. BK110051Automated Blood Cell Separators
  532. K900082MAXX 470 CORE BIOPSY GUN
  533. K935898HYDROGUM
  534. K882002PREGNAGEN(TM)
  535. K790189ELECTREAT MODEL 250 TRANSCUTANEOUS STIM
  536. K843992CILCOR OPHTHALMIC INSTRUMENTS
  537. K994110LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
  538. K000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
  539. K874324MODEL A-17, BEHIND-THE-EAR HEARING AID
  540. K962192SUNRISE CURING LAMP
  541. K051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
  542. K781026ANTITHROMBIN III SERUM, ANTI-HUMAN
  543. K103407COTRONIC DIGITAL THERMOMETER
  544. K831783SERVOMED BASIC BEDSIDE UNIT SMV 104
  545. K994426GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
  546. K893741RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
  547. K221500ACUSON Sequoia Diagnostic Ultrasound System
  548. K201857Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
  549. K192495Black Diamond Navigation Instruments
  550. K973267TTM5000 TELEPHONIC EKG MONITOR
  551. K151540MC BIO Supertack Tack 3mm, 4mm and 5mm
  552. K914524FLUID PUMP, CP #3
  553. K810959SECURE
  554. K162662GingiDent Gingival Retraction Paste
  555. K212707CoolSculpting Elite System
  556. K092191EXILIS, MODEL 5000
  557. K203169Revolution Ascend
  558. K837355UNKNOWN
  559. K915800BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
  560. K832053SINGLE PATIENT SYS. II MODEL DM-450
  561. K103677M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
  562. K951809GLIDING NAIL
  563. K970988FAR-EAST BOUFFANT CAPS
  564. K022317DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R…
  565. K052833GORE-TEX NON-STERILE SURGICAL GOWNS
  566. K874373PT PRO-CLOT
  567. K864536OHMEDA 5500 AIRWAY PRESSURE MONITOR
  568. K974703CARBON FIBER BREAST BOARD
  569. K932141CARDIAC CATHETERIZATION KIT
  570. K083674PK-141 PATIENT CABLE
  571. K210237CINA CHEST
  572. K933086AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
  573. K172082S60 Series Digital Color Doppler Ultrasound System
  574. K912211INTRAVASCULAR CATHETER SECURMENT DEVICE
  575. K881865NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER
  576. K924562CATHETER INTRODUCER
  577. K896803CLOSED WOUND RESERVOIR
  578. K221218Silverlon Wound Contact, Burn Contact Dressings
  579. K241862Levina Pelvic Floor Muscle Stimulator (RS-48)
  580. K944097COMPASS SOFTWARE MODULE
  581. K821424TRYPTIC SOY AGAR W/5% SHEEP BLOOD
  582. K202068The AIO Solution 3.0
  583. K082766MODIFICATION TO MINISPIR, SPIROLAB III
  584. K052908INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
  585. K810671CCPD 3 LITER DRAINAGE SET
  586. K932235PRO. HI-LOW MAT TABLES #9610-9612 9620-9622
  587. K851299CORRECT FLO
  588. K113835DATACAPTOR SYSTEM
  589. K223620Reprieve by RegenesisTM
  590. K103840CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
  591. K875000PRISMA DISPOSABLE ENDO-OCULAR PROBE
  592. K810940THE BETA
  593. K812507THE KEOFEED STOMACH TUBE
  594. K141922IRIS INTELLIGENT RETINAL IMAGING SYSTEM
  595. K802756SEMI-OVAL MODULAR SUNTANNING BOOTH
  596. K193055Purzir Dental Zirconia
  597. K905629PEDICRAFT INFANT REFLUX WEDGE
  598. K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
  599. K830150VEINPREP VEIN GRAFT PREP. KIT A277723
  600. K210451OrthoGold 100
  601. K260948Air Compression Massager (EP30B001 I)
  602. K133775EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
  603. K922647COLOR DISKSTORE
  604. K822790MICRO-CRAFT OSCILLATING SAW HANDPIECE
  605. K913786FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
  606. K823403ALLERCOAT POSITIVE CONTROL SERUM
  607. K983449GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
  608. K941745TSX-002A (XVISION) CT SCANNER
  609. K820972BIOPSY FORCEPS W/OVAL CUPS
  610. K862873IUC - INTRAUTERINE CATHETER
  611. K081624INFX-8000F (INFINIX CSI AND INFINIX DPI)
  612. K945270CUSTOM ARTIFICIAL HUMAN EYES
  613. K903728SYNERMED DIRECT BILIRUBIN REAGENT KIT
  614. K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl…
  615. K090297BLUESHINE GOLD SERIES
  616. K862116STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
  617. K231208Stryker Resorbable Fixation System
  618. K896695DYNA-FLO URINARY DRAINAGE BAG
  619. K982472GENICON TROCAR
  620. K771667BLOOD GAS TRAY #4024
  621. K070818MEDILOGAR4, MEDILOGAR12
  622. K124027MONSTER SCREW SYSTEM
  623. K160413Sterling 5W Diode Laser
  624. K093897SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
  625. K954904MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER
  626. K223410Cios Select (VA21) Flat Panel
  627. K973166DOW CORNING SILASTIC ELASTOMER Q7-4750
  628. K901951MODEL# MPC
  629. K060976MOORLD12-B1 LASER DOPPLER BURNS IMAGER
  630. K923107BODY BAND RESTRAINT STRAP SET
  631. K173600MAGNETOM Amira
  632. K152483Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
  633. K120447X4
  634. K083151EXTREMITY MEDICAL SUTURE ANCHOR
  635. K172661Fetzer Medical Gynecological Forceps
  636. K180163TransEnterix Senhance Surgical System
  637. K042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
  638. K010213MODIFICATION TO CAVERMAP SURGICAL AID
  639. K110079SPPHINE PLUS STM 3W DIODE LASER
  640. K163222Discovery Pico Family
  641. K250010EXTRON 3; EXTRON 5; EXTRON 7
  642. K182402CoLink View Plating System
  643. K984448BIRCOLL BALLOON DISSECTOR
  644. K131775UNIVERSAL NEURO 3 SYSTEM
  645. K1203673MENSIO WORKSTATION
  646. K802351F110 PHOTO BINOCULAR OPHTHALMOSCOPE
  647. K111914VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
  648. K073155VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
  649. K953494TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A…
  650. K894600CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
  651. K132039ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
  652. K813189PHADEBAS/PHADEZYM IGE REAGENTS
  653. K120089BIOGENESIS IMPLANT SYSTEM
  654. K863264INORGANIC PHOSPHORUS PROCEDURE
  655. K930411UNIVERSAL WHEELCHAIR
  656. K020072ATHOS LASER
  657. K843050GRAM STAIN
  658. K864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
  659. K822610PRECAPSULED DENTAL AMALGAM
  660. K833961I/A PLUS PAK SURGICAL SYSTEM
  661. K931915STAINLESS STEEL SUTURE
  662. K081312ARAGON ONESHOT SYSTEM
  663. K972893PARTNERSHIP REVISION FEMORAL STEMS
  664. K000106DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
  665. K032991LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
  666. K030656ENVAN HEART RATE MONITOR
  667. K902229COULTER CARBON DIOXIDE REAGENT
  668. K231394Intense Pulsed Light System
  669. K033699LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587…
  670. K043573DYNAGRAFT II DENTAL
  671. K972100VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
  672. K041493CEMENTEK
  673. K014141DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
  674. K970645BC THROMBIN REAGENT
  675. K251491K5 Cart, K5 Mount, K5 Swing
  676. K952961BODY FLUID BARRIER KIT
  677. K133819VERADIUS
  678. K897114EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
  679. K943356INCLUSIVE ENDOSCOPE
  680. K200696FIREBIRD SI Fusion System
  681. K130817LTN - LAPAROSCOPIC SURGICAL MESH
  682. K111598POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
  683. K770012Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C
  684. K061018PLANAR DOME EX LINE MODEL DOME E2C
  685. K170349RA-308 Excimer Laser System, Excimer Laser Catheter
  686. K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
  687. K873049TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
  688. K082542ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
  689. K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)
  690. K932708PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS
  691. K024213SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910…
  692. K171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
  693. K871225HAND SURGERY TABLE EXTENSION
  694. K832396CENTRAL VENOUS ACCESS CATHETER CVAC
  695. K203279Veuron-Brain-mN1
  696. K180016Home Use IPL Beauty Device
  697. K112826NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
  698. K173654Ureteral Dilator Sets, Ureteral Dilators
  699. K191360i-STAT CHEM8+ cartridge with the i-STAT 1 System
  700. K251106Sonosite LX and Sonosite PX Ultrasound Systems
  701. K001524FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
  702. K191379RELiZORB
  703. K953343NEEDLELESS INJECTION SITE
  704. K163430Prontosan Wound Gel
  705. K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
  706. K010801T2 FEMORAL NAIL
  707. K091166IMRX
  708. K892845SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE
  709. K233215icotec Anterior Cervical Plate System
  710. K123098XGEO GC80
  711. K100102CS-SERIES-FP
  712. K770599NUVA-LITE II PHOTO-CURE UNIT
  713. K853971REGULATOR-INHALATOR SYSTEM
  714. K912408MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
  715. K843876LEUKOFLEX SURGICAL TAPE
  716. K994358ATW MARKER WIRE STEERABLE GUIDEWIRE
  717. K970920SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
  718. K8229141424 TUMISTORE
  719. K800762PS3 TITANIUM SCREW DENTAL IMPLANT
  720. K945378PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
  721. K971857MUMPS IGG ELISA TESTY
  722. K9001083M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
  723. K7613608 LATEX EXTENSION TUBE WITH CONNECTOR
  724. K132924MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
  725. K800546BUNN VOLUMAIRE RESPIRATORY EXERCISER
  726. K940537KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
  727. K231078All-Suture Anchor
  728. K180138AtriCure cryoICE cryo-ablation probe (CRYO2)
  729. K872542SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER
  730. K203146Akesis Galaxy RTi
  731. K051469CAREVENT ATV+ AND CAREVENT MRI
  732. K932301FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER
  733. K130909GATEWAY ADVANAGE Y-ADAPTER
  734. K002932PHACOGARD
  735. K944400PEDI-CAP
  736. K121185EDWARDS PERCUTANEOUS SHEATH INTRODUCER
  737. K772286FORCEPS, SUTURE, AUTO
  738. K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
  739. K033457M2 COMPATIBLE MICROKERATOME BLADE
  740. K952336DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
  741. K880713CLP 0.1 M SODIUM CITRATE SOLUTION
  742. K904337OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.
  743. K810599DADE RH CONTROL REAGENT
  744. K153386Perla Posterior Cervico-Thoracic Fixation system
  745. K980429HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY…
  746. K151360Inion Spinal Graft Containment System
  747. K972235PRECICONTROL TUMOR MARKER 1 AND 2
  748. K896951SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM
  749. K213696ETHICON Megadyne Electrosurgical Generator
  750. K833353ACLAIM-QAP IBM PERSONAL COMPUTER EDT
  751. K934812COMFIT GREEN POWDER FREE EXAMINATION GLOVE
  752. K981476CHOL
  753. K841910KERR SEALAPEX ROOT CANAL SEALER
  754. K113194POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
  755. K812867STERI-VAC #400C GAS STERILIZER
  756. K981581IRON
  757. K964520PARASCAN SCANNING DEVICE
  758. K941610CLENSICAIR LOW AIRLOSS HYDROTHERAPY
  759. K771021AUTO-CLIP
  760. K932661WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
  761. K951162PHENO-CEN GERMICIDAL DETERGENT
  762. K950521OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
  763. K761261ENZYMATIC BUN (RATE) REAGENT KIT
  764. K040134THERILINK BONE VOID FILLER
  765. K032229QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
  766. K840944INFUSION NEEDLE IIPN
  767. K083694SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
  768. K802194MINOCYCLINE 30MCG. SENSI DISC
  769. K130177ANATOMIC PEEK CERVICAL FUSION SYSTEM
  770. K000501ELECTROSURGICAL GENERATOR, MODEL S1
  771. K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
  772. K120838SYNTHES MATRIX SYSTEM
  773. K070825LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
  774. K831341API UNISCEPT PLUS AUTOINOCULATOR
  775. K850077MEDTRONIC 5311 PACING SYSTEM ANALYZER
  776. K935951KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
  777. K961312HEMOCUE B-HEMOGLOBIN SYSTEM
  778. K120448MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE…
  779. K992519NRC NON-RINSE CONDITIONER
  780. K043307CRANEX D
  781. K885094BIOTROL ALBUMIN
  782. K830738LENSERT CONTACT LENS CLEANING & INSERT
  783. K083527INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
  784. K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
  785. K831101TIA-IGG REAGENT & CALIBRATOR SETS
  786. K902612CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
  787. K922591UROLOGICAL C-ARM TABLE, MODEL #056-450
  788. K891850AMMEX LATEX EXAMINATION GLOVES
  789. K181492Elecsys CA 15-3 II
  790. K902699SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)
  791. K221737InstaFill Graft Delivery System, SIGNIFY Bioactive
  792. K201235Arthrex MaxForce MTP Compression Plates and Screws
  793. K860185UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER
  794. K041441SAS INFLUENZA A TEST
  795. K081146ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
  796. K823880BACTIGEN-N. MENINGITIDIS
  797. K910749FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR
  798. K864239CLED AGAR WITH ANDRADES INDICATOR
  799. K191004Advocate Non-Contact Infrared Thermometer
  800. K822450AURAFILL* DENTAL RESTORATIVE
  801. K840087PRESERV GOMORI TRICHROME STAIN 125/500
  802. K791411COAXIAL DUAL FLOW CATHETER
  803. K040508VITALAB MAGNESIUM REAGENT
  804. K260525NextMR Spine
  805. K052410ACUSON SEQUOIA ULTRASOUND SYSTEM
  806. K022528IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ…
  807. K905251MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A
  808. K042965TOMAS PIN
  809. K900673SERIAL FLOW
  810. K090355OPAL SEAL
  811. K862528IMMPULSE PHENOBARBITAL ASSAY REAGENTS
  812. K030553ARKIT HBA1C
  813. K842642BALSAN 700
  814. K043142INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
  815. K254090I-View®
  816. K923440APEX DIRECT BONDED BRACKETS
  817. K972246SPECTACLE FRAMES (NON-PRESCRIPTION)
  818. K810848CYTOBUCKET MODEL 1024
  819. K923739ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR
  820. K000572E.N.S.I. SYRINGE
  821. K9520373 LPM OXYGEN CONCENTRATOR
  822. K984272MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
  823. K162017Ross Ru Wound Dressing Gel
  824. K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
  825. K953038DYNAMIC EQ/CLASS D
  826. K851361AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
  827. K812003A-GENT THEOPHYLLINE
  828. K172077Cutera enlighten III Laser System
  829. K880356N PROTEIN STANDARD PLASMA (HUMAN)
  830. K853991HOFMANN KNEE
  831. K141831HYDRAVIEW GUIDEWIRE
  832. K112141SMARTEPIL,DEPILASE YAG LASE PLUS
  833. K020203PADPRO MODEL #2516
  834. K960843STOP-N-GROW
  835. K191512LotusCatheter (Lotus No Balloon Catheter)
  836. K181777AggreGuide A-100 ADP
  837. K800376EPR-200 PROGRAMMER MODEL 010
  838. K935985DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION
  839. K831497SPIROMETRICS BREON 2400 & SMI 2400
  840. K910341POLARIS
  841. K844512DART DAILY AIR REMOVAL TEST
  842. K821573EOSIN Y SOLUTION ALCHOLIC
  843. K875119BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
  844. K142108RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
  845. K262130ATTUNE Revision Knee System
  846. K940907MADDEN SURGICAL THIMBLE
  847. K993386LATEX EXAMINATION POWDERED GLOVES
  848. K022481S2 TIBIAL NAIL
  849. K974106ICON IMPLANT SYSTEM
  850. K854184IN-VITRO TEST DETERMINATION OF TOBRAMYCIN
  851. K250168Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
  852. K871577HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES
  853. K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
  854. K030612GENESIS II TOTAL KNEE SYSTEM
  855. K100989ZURA TEE SYSTEM WITH CLARITEE PROBE
  856. K922513COMFIT STERILE LATEX EXAMINATION GLOVE
  857. K161588Vscan Extend
  858. K954105EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
  859. K991287SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
  860. K870504NORTA (TM) UROBAG
  861. K833697EXTRA SENSORY PAK-DISPOS. ACCESS
  862. K250902HeartFlow Analysis
  863. K852386SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT
  864. K823748EXPANDED PTFE PROSTHESIS BLOOD ACCES
  865. K202306T3 Platform software
  866. K791716PLAQUE-X DENTURE CLEANSER
  867. K010984EMIT 2000 GENTAMICIN PLUS ASSAY
  868. K132559MONUMENT SPACERS
  869. K110383BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
  870. K921436SONICATOR PLUS
  871. K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
  872. K160084Swan Ganz Catheters
  873. K023286CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
  874. K223539Dreem 3S
  875. K822170INCUS NIPPERS
  876. K011610LIVESURE METHAMPHETAMINE SCREEN TESTS
  877. K863296INFUSE-A-PORT EXPLANT KIT
  878. K0320458 CHANNEL CARDIAC PHASED ARRAY COIL
  879. K053031EXTENDSURE HBFASC CONTROL
  880. K140123POLARIS SPINAL SYSTEM -TRANSLATION SCREW
  881. K810711HAEMONETICS 600 ML. COMPONENT BAG
  882. K954397BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY
  883. K944049OXYGEN MOUTHGUARD
  884. K192200DynaCAD
  885. K980937NICORE MODEL ESP -1
  886. K810712ELECTRONIC SPIROMETER MODEL MFR-8100
  887. K9429270.035 IN. WISE WIRE
  888. K801109PROOF (BIOLOGICAL/CHEMICAL INDICATOR)
  889. K960582ASCEND GENERAL PURPOSE DISINFECTANT
  890. K893912TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD
  891. K043537TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
  892. K121095DX-D IMAGING PACKAGE
  893. K932659MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM
  894. K152152Codman Certas Plus Programmable Valve
  895. K110252BEAUTIBOND MULTI PR PLUS
  896. K891658REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES
  897. K003896LYMPHA VISION-EXPERT
  898. K212036Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
  899. K141902LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER
  900. K260188LimFlow Vector
  901. K001046BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
  902. K872253CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
  903. K843793A-T TENS BELT
  904. K062909REPEATER PUMP II TUBE SETS
  905. K122589DFP4343C7
  906. K150068Unimicro Veress Needle
  907. K203314Cartesion Prime (PCD-1000A/3) V10.8
  908. K812128RECON 1
  909. K121911OCTAVE SPEEDER SPINE
  910. K942575CEDIA T4 MAB ASSAY
  911. K854615MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
  912. K935774CURITY FAST-CATH FEMALE CATHETER KIT
  913. K992886POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
  914. K011340LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
  915. K926372MCA 200 HEMPDIALYZER
  916. K181622StrataMR guider tool
  917. K885028COULTER 5P CONTROL
  918. K843851BODYSCREEN II
  919. K934556EMS-250
  920. K841293PANORAMIC LOUPES - VARIOUS
  921. K993841CEMSTOP CEMENT RESTRICTOR
  922. K112881NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH…
  923. K940175MEDSURG STERILE O.R. TOWELS
  924. K770116PORTA-PRO TOOTH POLISHER
  925. K921129MRX-700
  926. K213596OSSIOfiber Compression Screw, 3.5mm
  927. K951724QUANTITATIVE EEG ANALYSIS SOFTWARE
  928. K183363Treace Medical Concepts (TMC) Snap-Off Screw System
  929. K123541SYNGO.CT NEURO PERFUSION
  930. K984298Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
  931. K003212FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
  932. K951926ALRECO 40400
  933. K852897LEE BONE MARROW BIOPSY/ASPIRATION TRAY
  934. K761307AUTO SYRINGE MODEL AS-3A
  935. K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
  936. K882343TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
  937. K0520433.8MM CS FACET COMPRESSION DEVICE
  938. K883314PMT 3721-1 EPIDURAL KIT
  939. K950820SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
  940. K823059DOSIMETRY RELEASE OF RADIATION STERIL.
  941. K970521TRX POWER TILT AND RECLINE SYSTEM
  942. K042544UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
  943. K192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
  944. K150878ILUMIEN OPTIS
  945. K192696TriMed ASET Foot Plating System
  946. K883188T.E.N.S. UNIT SIGMA & TX-3
  947. K030874GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
  948. K834532STERILE WET DRESSING PACK
  949. K881327STUART CANNULATED CANCELLOUS BONE FIXATION SCREW
  950. K181565Aquarius 8600 Digital Radiography Sensor
  951. K042341ULTRACLIP II US
  952. K110856RALCO
  953. K831793AQUALIZER MOUTHPIECE
  954. K874996PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.
  955. K101175KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
  956. K040881METACRYL
  957. K091916INNOVANCE D-DIMER, MODEL OPBP09
  958. K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
  959. K911080HYGIENA-TRACH
  960. K880185DUET (CONDOMS)
  961. K833379LIDOCAINE ANALYTICAL TEST PACK ACA
  962. K163547MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
  963. K151247NC Straumann Screw Retained Abutments
  964. K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
  965. K142319SCIg60 Infuser, Infuset
  966. K884354IMAGER FLUSH CATHETERS
  967. K040466BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
  968. K183529AE-120A EEG Head Set
  969. K803312MICROMEDIC AUTOMATIC COMPUTING CENTER
  970. K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq…
  971. K092450HUMAN IGD KIT FOR USE ON SPAPLUS
  972. K211220Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…
  973. K953458RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
  974. K813050AQUANOMICS, #MP4SF
  975. K981562SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
  976. K781428FLEXTUBES:9, 20, 26
  977. K940141LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
  978. K890886ABUSCREEN FP FOR AMPHETAMINE
  979. K861331ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
  980. K944155PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
  981. K260144Reclining wheelchair (YJ-013L)
  982. K933452MULTIPLE
  983. K082659MODIFIED ENDO STICH
  984. K163050Advance Medical Designs, Inc. Sterile Ultrasound Gel
  985. K180777K2M Expandable Interbody System
  986. K060324BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN…
  987. K172446SPIRA-C Open Matrix Cervical Interbody
  988. K772208CULTURE COLLEC. TRANS. SYS., SINGLE DRY
  989. K873047KEANE MOBILITY BED
  990. K905518BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
  991. K871363MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
  992. K053025JOSTRA HLM TUBING SET
  993. K870072SUMMIT OPTICS CONTACT LENS REMOVER
  994. K071064ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
  995. K093101MAGO 4S
  996. K973215STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
  997. K993667SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
  998. K822556CRITICAL MEASUREMENT UNIT
  999. K955146AXIOM-HVG
  1000. K130487FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE

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