Orca1

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510(k) premarket notifications

About 178K records

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

  1. K953272PULPDENT DENTASTIC II
  2. K881195DYNATECH SPD 2000, NUMBER 002-910-0000
  3. K893207CLOSED CHEST SUPPORT CIRCUIT
  4. K900937O.R. DATA MANAGER
  5. K191249CARESCAPE B450
  6. K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee…
  7. BK920030Solution, Stabilized Enzyme
  8. K112771BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
  9. K250218Xpert® FII & FV
  10. K823137OCTAPETTES
  11. K904305DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
  12. K030925PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
  13. K945526LUNAR EXPERT
  14. K133062DISCOVERY SYSTEM
  15. BK120018Automated Blood Cell Separators
  16. K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
  17. K904785CRI CYNOSAR CATHETER
  18. K853535TRAUMA TABLE
  19. K841239ASSIGNED VALUE FOR MEAN PLATELET
  20. K973163ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
  21. K192408Custodiol HTK Solution
  22. K922563LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)
  23. K922046LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
  24. K011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
  25. BK210621Test, Residual, WBC in Leukoreduced Blood
  26. K053391X-TRA FIL
  27. K033539DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
  28. K950909TRANSIT-2 INFUSION CATHETER
  29. K141631AQUARIUS EXTENSION FEEDING SET
  30. K881532BLOOD AGAR BASE W/LOW PH
  31. K252748Pelvic Floor Exerciser (PF01)
  32. K071848IPS INLINE POM SYSTEM
  33. K934898GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
  34. K223886Wearable Breast Pump (Model S18)
  35. K130013X4 SYSTEM
  36. K032442KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
  37. K923611ULTRA THIN BALLOON DILATATION CATHETER
  38. K120470MIPAL
  39. K183014uPMR 790
  40. K926170STEPMILL EXERCISE SYSTEM
  41. K844573ABSORBABLE GAUZE PRODUCTS
  42. K802356VON WILLEBRAND FACTOR ASSAY
  43. K841352ND1200 RIA COUNTER
  44. K972190THYROGLOBULIN ASSAY SYSTEM
  45. K233562LINQ II Insertable Cardiac Monitor
  46. K941755ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT
  47. K972675CO2 GAS WARMING UNIT (6-800-00)
  48. K213820BALTEUM - ONE™ Lumbar Plate System
  49. K151672Cerner CareAware Event Management
  50. K970353AURA TEK FDP
  51. K964379KSEA PUNCTURE CANNULA
  52. K113334AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
  53. K900386ACS ADVANCED CONCEPT GUIDE WIRE
  54. K200040Universal Base Conical Connection (CC)
  55. K853129BEAVER MULTIPURPOSE SAPPHIRE KNIFE
  56. K023941SYNTHES TOMOFIX OSTEOTOMY SYSTEM
  57. K212538DESS Dental Implants
  58. K043028EMIT II PLUS ECSTASY ASSAY
  59. K913397MEGA ANGIOGRAM KIT
  60. K933405COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
  61. K132374BAYLIS MEDICAL RF PERFORATION PROBE V2.0
  62. K933150NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE
  63. K221148Vivid iq
  64. BK900029Supplies, Blood-Bank
  65. K060287DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
  66. K854876ALDOSTERONE DIRECT RIA KIT
  67. K843095TRIA LENS SET
  68. K023499GOLD CORE PLUS
  69. K770320URINARY DRAINAGE SET, CLOSED, STERILE
  70. K8728175 MHZ DOPPLER OUTRIGGER
  71. K130149U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
  72. K970560URIC ACID (LIQUID) REAGENT SET
  73. K973468MODEL IRC 1199 SCOUT NEBULIZER
  74. K021190PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
  75. K033197INOGEN SATELLITE CONSERVER
  76. K080108CORTOSS BONE AUGMENTATION MATERIAL
  77. K812913OMEGA II ANGIOGRAPHIC TABLE
  78. K090867AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM…
  79. K173884Unity Total Knee System
  80. K822445HCT CENTRIFUGE
  81. K925624MICROSURGICAL INSTRUMENTS
  82. K842352PRESSURE MONITORING KIT
  83. K092038APTUS K-WIRE SYSTEM
  84. K840858OHIO 3300 INFANT WARMER SYSTEM
  85. K830799INDUCTIVELY-COUPLED PLASMA SPECTROMETER
  86. K190416Dome Electrode
  87. K082626PAM 3000
  88. K831526URINE TOTAL PROTEIN CONTROL
  89. K890691ADX TM BENZODIAZEPINES
  90. BK940062Container, Empty, For the Collection '& Processing of Blood/Blood Components
  91. K896339MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
  92. K864627WHITESIDE ORTHOLOC II METAL BACKED PATELLA
  93. K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS…
  94. K850659SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
  95. K882107PERFUSOR SECURA SYRINGE PUMP
  96. K971480DURALASTIC I AND DURALASTIC II
  97. K200303Reform Pedicle Screw System
  98. K840495MANUAL IRRIGATING/ASPIRATING UNIT
  99. K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
  100. K905403MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
  101. K030349HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
  102. K970650ASAHI AM-R SERIES DIALYZERS
  103. K972993CHASE FEMORAL ACCESS CANNULATION SET
  104. K942399KYOKKO UM SERIES INTENSIFYING SCREEN
  105. K790547PRO-TAB
  106. K810549THERMAL PRINTER PAPER
  107. K894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
  108. K022843GAYHEART CORNEAL EXCISION DEVICE
  109. K883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
  110. K193510Terason uSmart3200T Ultrasound System
  111. K192148Freedom Primary PCK
  112. K260308TrueFit Bolus
  113. K210830VUZE System
  114. K964869NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
  115. K050856LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
  116. K051316X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
  117. K780266BONE CEMENT APPLICATOR
  118. K781953RIA KIT, IMMO PHASE
  119. K852177FOAM ECG ELECTRODES
  120. K974208TYTRON C-3000
  121. K802505DOUBLE LUMEN TRACHEAL TUBE
  122. K013582MAYBE?MOM MINI OVULATION MICROSCOPE
  123. K822349ARMSTRONG V TUBE SUCTION INSERTER
  124. K914476VITAPAN ACRYLIC DENTURE TEETH
  125. K810237PORTABLE, BATTERY OPERATED DEFIBRILLATOR
  126. K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM…
  127. K041722MODIFICATION TO VBR SPINAL SYSTEM
  128. K970692UNITRON MODEL SOUND F/X CIC
  129. K832195LUNG POWER
  130. K000893AC POWERED THERMAL CAUTERY UNIT
  131. K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
  132. K962224SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
  133. K914008PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
  134. K193514AUTION MAX AX-4060 Urinalysis System
  135. K192402syngo.CT Extended Functionality
  136. K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…
  137. K160551VALO Grand
  138. K950770CPR MICROSHIELD II
  139. K243334Nooro Body & Foot Stimulator (SM9141, SM9142)
  140. K211224RM4 Control Unit
  141. K963542SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
  142. K860882DISPOSABLE CATHETER
  143. K891301PATIENT EXAMINATION GLOVES (LATEX)
  144. K031837MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
  145. K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…
  146. K910439FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)
  147. K942113CARBON DIOXIDE ANALYZER (MODEL CD-3A)
  148. K042089NX STAGE WATER PURIFICATION SYSTEM
  149. K900184LINGUAL SHEATH
  150. K820562CAMPYLOBACTER SELECTIVE MEDIUM
  151. K970431BEHRING COAGULATION SYSTEM
  152. K822686DENVER PERITONEO-VENOUS SHUNT (DP-VS)
  153. K112930MOBILE MIM
  154. K933906CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
  155. K854109ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345
  156. K954609HEARTSTART 911
  157. K944954ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS
  158. K223072PENTAX Medical Video Esophagoscope EE17-J10
  159. K103335GEM OPTION FOR 1.5 MRI SYSTEMS
  160. K772247COMPLEMENT C4 NEPHELOMETRIC ASSAY
  161. K212897IPL Hair Removal Device, model: AI01
  162. K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…
  163. K832895VISION TWO, ONE/10 ONE/20 &24
  164. K042132NOVASYS TRANSURETHRAL RF SYSTEM
  165. K781811TRANSFER PAK 4R 9006
  166. K781777ABRASIVE WHEELS
  167. K964874HSV-1 ANTIGEN CONTROL SLIDES
  168. K911996SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
  169. K830073LEVINE EMB AGAR
  170. K943693PULSEMASTER S SERIES
  171. K843286EI-CANDIDA ENZYME IMMUNOASSAY EI1001
  172. K884079MODEL CBX EPILATOR
  173. K021627SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
  174. K915161AUGUSTINE FIBEROPTIC LARYNGOSCOPE
  175. K810448WHEELCHAIR ACCESSORIES
  176. K912463MICRO-Q
  177. K950041SII 360 APR
  178. K960045ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
  179. K894610CUSTOM TRAYS, KITS
  180. K180346Byte Aligner System
  181. K241444Biliary Pancreaticobiliary Scope System
  182. K812877PENASE
  183. K992037MAMEX
  184. K233142EndoSign® Cell collection device (ES-CYT-102)
  185. K152829Visions PV.014P RX Digital IVUS Catheter
  186. K173663Electronic Stethoscope DS3011A
  187. K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
  188. K931843HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
  189. K203749Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
  190. K760328RAZOR, DISPOSABLE
  191. K855111DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES
  192. K933966SURE-ADAPT NON-ADHERING DRESSING
  193. K920719IVOS ANALYZER
  194. K051043VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
  195. K931175SCHUSTER DISPOSABLE BALLOON PROBE
  196. K121710XPERT CT/NG
  197. K924495PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM
  198. K792351MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
  199. K972195POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
  200. K012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
  201. K162217LOYON
  202. K891009INTRAVASCULAR ADMINISTRATION SET MODEL 60040
  203. K974351BIOLOG 3000 ELECTROCARDIOGRAPH
  204. K172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with…
  205. K940070STOPCOCK INTRAVENOUS THERAPY
  206. K881505MAMEX DC MG11
  207. K885113IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
  208. K221108Nitrile Medical Examination Gloves
  209. K860786RPMI 1640 HEPES
  210. K792040BARD BIOMEDICAL PRINTED SILVER ELECTRODE
  211. K150053STALIF C; STALIF C-Ti
  212. K132406ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
  213. K850156ECG PATIENT MONITOR 301
  214. K051281THE NEEDLE CATCHER
  215. K131029ACCU-CHEK AVIVA PLUS TEST STRIP
  216. K050207BD POSIFLOW POSITIVE DISPLACEMENT VALVE
  217. K961122STRYKER KNIFELIGHT
  218. K934703MEDICOOL PROTECTALL
  219. K882805CILCO VILLASENOR PACHYMETER
  220. K945012CATCO NUTRITIONAL CATHETER
  221. K992746SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
  222. K901336ASI HEMOSTASIS CATHETER
  223. K760472INSTRUMENTED SYSTEM FOR URINALYSIS
  224. K212644Aura Storm
  225. K170108Xultan 5.5 Pedicle Screw System
  226. K993969SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
  227. K960508PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
  228. K811600BILE ESCULIN MEDIA
  229. K242367BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
  230. K770299TYGON M-60/TYGON M-70
  231. K970127EDOSSEOUS DENTAL IMPLANT
  232. K961306DELTATALKER WITH INFRARED
  233. K791530OHIO MODULAR ANESTHESIA GAS MACHINE
  234. K874751TRACKER-25 INFUSION CATHETER
  235. K053561BIO-MINI REVO SUTURE ANCHOR
  236. K133974VARIAX DISTAL RADIUS PLATING SYSTEM
  237. K012681ANKYLOS
  238. K925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
  239. K861383SOLEX THERAPEUTIC PAD
  240. K083454NUOVOCATH
  241. K111643OPTO MITRA YELLOW LASER
  242. K150919ArgenZ Esthetic Plus
  243. K831665DISPOSABLE NEEDLE HOLDER
  244. K952862FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR
  245. K972827IPS EMPRESS COSMO INGOT
  246. K152531InstaClear Lens Cleaner
  247. K112844REHASTIM 2, REHAMOVE 2
  248. K191276Dental Electrical Motor iRoot Pro
  249. K890388CEPHALOTOMY SCISSORS
  250. K822664PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPP
  251. K062948SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
  252. K080047CARDIOSEN'C
  253. K201562Spirotrac
  254. K020708PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
  255. K771279HEAD FACILITATION VIBRATOR BK-5210
  256. K041166SIEMENS ENHANCED IMAGING SYSTEM
  257. K922106ALICE
  258. K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
  259. K760604EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS.
  260. K181949SYMPHONY™ OCT System
  261. K841158NEBULO 28 NEBULIZER KIT
  262. K141272FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA…
  263. K984641FLEXISCOPE OPTOMODUL
  264. K913601MICROPHOR
  265. K862183DAKO ITA, IMMUNOGLOBULIN A (IGA)
  266. K2232031.5T 24E Posterior Array
  267. K070462XPERT MRSA
  268. K112267NEUROLAC(R) NERVE GUIDE
  269. K161633REXLON, REXSIL
  270. K893843EZ-BEAD DIGOXIN EIA KIT
  271. K052626SMARTSUCTION HARMONY DEVICE
  272. K910703ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID
  273. K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…
  274. K902952IL PHENYTOIN ASSAY SYSTEM
  275. K192103Thunderbeat Open Fine Jaw Type X Hand Instrument
  276. K921773TX ELECTRIC TOOTHBRUSH
  277. K071984MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
  278. K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
  279. K840252RIM GRAM REACTION SWAB
  280. K041813GE LOGIQ 7 ULTRASOUND BT04
  281. K895576PATIENT EXAMINATION GLOVE
  282. K850771OSTER MASSAGE WAND STICK MASSAGER 295-07
  283. K800061BOND ELUT COLUMNS
  284. K141041APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
  285. K801134MICROVAC
  286. K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…
  287. K771968WHIRLPOOL BATH MODEL 2273
  288. K912954STRETCH GAUZE BANDAGE
  289. K924471KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
  290. K081767AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
  291. K912880VITALMAX 510/520
  292. K850939ALWAYS SUPER MAXIPAD-SCENTED
  293. K201210The Micro Screw System, Micro Screw System Basic
  294. K971539NOVATIP FAMILY OF LASER HANDPIECE TIPS
  295. K831580PARAFFIN INFILTRATION MEDIUM
  296. K141502HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
  297. K090773CFI ULTRASOUND PROBE DRAPE
  298. K890667RUBBER DAM
  299. K813639SERIES 400 DISPOSABLE TEMPERATURE PROBE
  300. K202005NovoFine Plus 32G Tip x 4 mm
  301. K223139Wallaby 017 Micro Catheter
  302. K791245CONPHAR EXTERNAL CATHETER
  303. K041350SYNTHES (USA) CHRONOS
  304. K033708MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
  305. K890206E-Z-FLOW ANGIOGRAPHY CATHETERS
  306. K220129Promisemed X-Safety Pen Needle
  307. K180265COMPACT TOUCH Ophthalmic Ultrasound System
  308. K230106General Cutting Straight
  309. K833530DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
  310. K863046ULTRA SOFTWARE MODULE: MODEL 2016
  311. K190719Artemis Eye System
  312. K934645RADWORKS
  313. K760955PHADEBAS T4 RIA
  314. K862538SENTRY BREAKWAY NECK STRAP
  315. K803287CHOLESTEROL REAGENT ENZYMATIC
  316. K023365LEFORTE SYSTEM BONE SCREW
  317. K896737TYPE 9292 INTERFACE CAPNOGRAPH
  318. K061656LASER-D68
  319. K935274DIPRIVAN LUER CONNECTOR
  320. K933729ASSURE SELF SEALING STERILIZATION POUCH
  321. K132848PIEZOSURGERY FLEX
  322. K023456OXYBOX SYSTEM
  323. K822601FIXATION MONITOR
  324. K122576TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
  325. K843304BINOCULAR INDIRECT OPHTHALMOSCOPE
  326. K792578EPIC CANNULA
  327. K872389PRECISION SCREW DRIVER SET
  328. K923366TILT SEATING SYSTEM
  329. K080556ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
  330. K982134DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851
  331. K953114EVOLUTION MICROCATHETER
  332. K060897EMBEDDING TOOL, MODEL TE-1000
  333. K070204LINK TO ACUITY CLINICIAN NOTIFIER
  334. K895462OSSEODENT DENTAL ATTACHMENTS
  335. K820870URETERAL STANT SET
  336. K821975ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
  337. K945815DENTAL KIT
  338. K170720Portex Blue Line Ultra Paediatric Tracheosomy Tube
  339. K892373DENTAL PLASTIC BITE FORK
  340. K120465EARLYSENSE (EVERON) SYSTEM
  341. K851122PI-PNEUMO INTESTINAL STAPLING CARTRIDGE
  342. K874470MWI 400 WOUND DRESSING
  343. K860062OCULAB PACHPEN
  344. K950391NON-PRESCRIPTION SUNGLASSES
  345. K760178ELECTRODE, CUTTING LOOP
  346. K003047AMBULATORY ENTERAL NUTRITION PUMP
  347. K110991MESA SPINAL SYSTEM (KEYSTONE RODS)
  348. K173656Arthrex FibuLock Nail
  349. K913272EMS/400
  350. K855205MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
  351. K860515DUAL LUMEN NEEDLE (PRODUCT CHANGE)
  352. K992648ROTARY MASTER
  353. K072863ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
  354. K862563TRACHEOSTOMY CLEANSING SOLUTION
  355. K931167OVAMED FALLOPIAN OSTIAL ACCESS CATHETER
  356. K142575Bard RiteCath Intermittent Urinary Catheter
  357. K823918AUSTIN MODIFIED PARTIAL OSSICULAR RE-
  358. K251940PathLoc Lumbar Plate System
  359. K122981RAYSCAN A-EXPERT 3D
  360. K873146USI BASIC. AG 1050. AG 1090
  361. K864157OPTI-BRUSH
  362. K864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO
  363. K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
  364. K192090CMOS Video Rhino-Laryngoscope SSU
  365. K963825AUTO SUTURE* ABBI* SYSTEM
  366. K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH…
  367. K902844NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN
  368. K920008IL TEST IMMUNOGLOBULIN M (IGM)
  369. K151776Central Venous Pressure System
  370. K081768COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
  371. K091495SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B…
  372. K953782NIL
  373. K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge…
  374. K152412T-32;T-40;T-44;T-52;T-72;TT-50
  375. K063206DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW…
  376. K233268Impress Angiographic Catheter
  377. K142816AbbVie J
  378. BK940019Supplies, Blood-Bank
  379. K062313SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
  380. K000028RENAFLO II HF 2000 HEMOFILTER
  381. K171530Deltaven XiV Max, Deltaven XiV Max FF
  382. K102405INFUSION SET FOR POWERPICC SOLO 2 CATHETER
  383. K231719Medical Surgical Mask
  384. K041608C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
  385. K081743CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
  386. K792062THEOPHYLLINE RIASSAY
  387. K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
  388. K132075PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)
  389. K000629FLEXTIME
  390. K935319CHEMILUMINESCENCE LH
  391. K930401ALUMINUM FOIL
  392. K200638LAP-iX Suction Irrigation
  393. K801311BURRON MULTI-AD SYRINGE CAP
  394. K837605MV/CM2 NUMBER X74294 MODEL NUMBER 74229
  395. K810297DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
  396. K173462Wireless Pain Relieve Device Model: LT5018C
  397. K760502VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.
  398. K231855QOCA® image Smart RT Contouring System
  399. K802840ALPHA-ANTIPLASM ASSAY
  400. K173782UNiD Patient Specific 3D printed cage
  401. K052284REFORMAT GATEWAY
  402. K151276DePuy Synthes T-PAL Ti Spacer
  403. K874650PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
  404. K881772SENSOCOR(TM) R-TEST 240 XL
  405. K840757ELVI 444 BILITRON
  406. K791254CONPHAR SILICONE DRAINS-STERILE
  407. K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
  408. K143039CrossRoads Screw System
  409. K800293FILE, PULP CANAL
  410. K870067MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20
  411. K162180Disposable Insulin Syringe
  412. K901598FASTIDIOUS MIC PANEL
  413. K834437KEATES IRRIGATION/ASPIRATION/VITREOUS
  414. K922340ENCORE SS-B
  415. K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist…
  416. K960205CPR TRACHEOTOMY CARE TRAY
  417. K900865ADD-A-VIAL II BINARY CONNECTOR
  418. K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
  419. K760565VENTILATOR CIRCUITS
  420. K994435OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
  421. K183332“BRAXX” Esophageal Brachytherapy Applicator
  422. K020615SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
  423. K033429LAMITRODE SPINAL CORD STIMULATION LEADS
  424. K22139414HQ701G-B
  425. K160655OrthoButton CL
  426. K020588X-IMAGE DIGITAL X-RAY SYSTEM
  427. K902173COULTER SERUM IRON/UIBC REAGENT
  428. K851715830/4 TO 848/7 VARIOUS TYPES CHISELS
  429. K983572SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
  430. K827708ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4
  431. K040452VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
  432. K203155BreatheSuite MDI V1
  433. K070689LG SPERM FREEZING
  434. K830487HEMO-PROCESSING SYSTEM
  435. K002689SWABSITE SWABBABLE VALVE, MODEL 245000
  436. K173343Zygomatic Implant System
  437. K823153BATH TUB SEAT & BATH BOARD
  438. K812434DIAGNOSTIC KITS & KIT COMPONENTS
  439. K893910EMIT CONVENIENCE PACK: DIGOXIN ASSAY
  440. K982630MEDWORKS VISUALIZATION INSEMINATION CATHETER
  441. K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
  442. K982617TRACER
  443. K933233CEEGRAPH, MODIFICATION
  444. K110631VENNER TRACHEAL SEAL MONITOR
  445. K760175DRAPE, TRANSURETHRAL RESECTION (TUR)
  446. K191981REMEDY Acetabular Cup
  447. K042273MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
  448. K932132EYSOTEK
  449. K192314RESONATE Anterior Cervical Plate System
  450. K873277MITRAFLEX(TM) WOUND DRESSING
  451. K102347GRANDTEC
  452. K260929Neonav ECG Tip Location System
  453. K884197DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
  454. K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
  455. K902368PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
  456. K884173#920 DISPOSABLE TUR CABLE
  457. K011839DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
  458. K840825SERIES MR IN-THE-EAR CUSTOM HEARING AID
  459. K791864INSTRUMENT PAD
  460. K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…
  461. K102324ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
  462. K160607PicoWay Laser System
  463. K872795CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
  464. K800724AMES LAB MANAGEMENT SYSTEM
  465. K083809CREATININE
  466. K770013PIPETTING DEVICES
  467. K936307DYNA-LOK ANTERIOR PLATING SYSTEM
  468. K760647ADAPTER, FIBER OPTICS HEADLIGHT
  469. K220716Spartan SC 069
  470. K153064Blue Sky Bio Zygomatic Implant System
  471. K834285KC 100 M
  472. K190520VITROS XT Chemistry Products GLU-Ca Slides
  473. K010247SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
  474. K090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
  475. K142773EOS System
  476. K962176TPP
  477. K141439ORTHODONTIC ACRYLIC (NOT FINALIZED)
  478. K990814CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
  479. K895409REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
  480. K001991TITAN POROCOAT HIP PROSTHESIS
  481. K792208DURAZYME GOT/AST
  482. K813532CUTTERBOND ZINC PHOSPHATE CEMENT
  483. K780587GYNESURG
  484. K821010BATHTUB TRANSFER BENCH
  485. K023803MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
  486. K942968AUTO SUTURE SPINAL OSTEOTOME
  487. K934826BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104
  488. K012220TAO EMBRYO TRANSFER CATHETER SYSTEM
  489. K896411REVISED PATIENT EXAMINATION GLOVES
  490. K0008254F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
  491. K092540C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
  492. K220590aPROMISE X
  493. K810590P.R.M. 80
  494. K854185IN-VITRO TEST DETERMINATION OF URIC ACID
  495. K900295PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
  496. K953690CLS STEM (MODIFICATION)
  497. K252306Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process…
  498. K150012CreoDent Solidex Customized Abutment
  499. K994300NASOGASTRIC TUBE HOLDER, MODEL 160
  500. K893871GOOTT BALFOUR BLADE
  501. K010070ULTRAPAK NEHA
  502. K760311INSTRUMENTS, GENERAL HAND & SURGERY
  503. K032149RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
  504. K833444LYSING & HEMOGLOBIN S-REAGENT J & S
  505. K083338CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
  506. K770825SPECTROPHOTOMETERS,34,35,36,3600
  507. K042461KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
  508. K822319RE1000 HEART RATE MONITOR
  509. K060416OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
  510. K813507INFALERT
  511. K844907CLINIFACTS 10 DATA MANAGEMENT SYSTEM
  512. K934631TRANSWARMER
  513. K955831ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
  514. K863610THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
  515. K113434LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
  516. K914946CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
  517. K850541SLEEP STAGER
  518. K250193Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid…
  519. K905754CAPNOMAC ULTIMA ANESTHESIA MONITOR
  520. K843081TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT
  521. K891531M-50 GOLD BASE DENTAL ALLOY
  522. K855149COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER
  523. K022493EMS 400
  524. K955292AELITEFLO
  525. K950983IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
  526. K861970LYPHOCHEK URINE TOXICOLOGY CONTROL
  527. K193361ProCell Surgical Sponge-Blood Recovery Unit
  528. K871391AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
  529. BK200520System, Hemoglobin, Automated
  530. K832766AMES TDA DISOPYRAMIDE TEST
  531. K221395Footmotion Plating System
  532. K962625VITAJET
  533. K925464CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
  534. K942484VERRES NEEDLE
  535. K041586PROFEMUR S HIP STEM
  536. K983054MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER
  537. K080374BIOSYAG MEDICAL SYSTEM
  538. K240987Access sTfR
  539. K811041BRILLIANT GREEN AGAR
  540. K821414MODEL 80 BC
  541. K231944CATAMARAN SI Joint Fusion System
  542. K834564MENSTRUAL PADS
  543. K234108ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable…
  544. K203472KMTI Hip Replacement System
  545. K954409PS MEDICAL IPI VASCULAR ACCESS CATHETER
  546. K940292ORVIS RIVER GUIDE GLASSES
  547. K080684WG-SURGICAL SUTURES WITH NEEDLE
  548. K223497Spectrum Saliva Collection Device
  549. K180044SIROLaser Blue
  550. K171736Geri Embryo Incubator and Geri Dish
  551. K900593TECHNICON H*2(TM) SYSTEM
  552. K2118043Delta Crown
  553. K955211SAS SALMONELLA H FACTOR 6 ANTISERUM
  554. K150494Proteus Digital Health Feedback Device
  555. K901555MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
  556. K801065NIKKISO PARALLEL FLOW DIALYZERS
  557. K883133HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER
  558. K163402NLZ Motor System
  559. K940561SUNGLASSES
  560. K130536EXPORT ADVANCE ASPIRATION CATHETER
  561. K243142Cranial 4Pi Immobilization
  562. K800268AUTOMATED RHEMATOID FACTOR TEST (ARFT)
  563. K072029PHENIX VERTEBRAL BODY REPLACEMENT
  564. K212349Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
  565. K980734MYELOTEC VIDEO GUIDED CATHETER
  566. K994076IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT…
  567. K070037POWDER FREE VINYL PATIENT EXAMINATION GLOVE
  568. K080823EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
  569. K090866NEUROCALM MODEL 1 AND 2
  570. K040558MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
  571. K922282ILLUMINATOR VIII ULTRA/SPOT
  572. K172886Breakaway Screw System
  573. K932271MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016
  574. K250001Patriot SI Implant System
  575. K770813ENDOGATOR
  576. K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
  577. K233077FlashHeal 2 (FlashHeal 2.0)
  578. K812776TRANSDUCER ANTISEPTIC TOWELETTE
  579. K920247AMERLITE MAB FT4 ASSAY
  580. K781949ELECTROSURGERY MODEL 771
  581. K770875IMPROVED THAYER MARTIN (JEMBEC)
  582. K042427GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
  583. K791362ELECTROSURGICAL CUT AND COAGU ACCESSORY
  584. K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
  585. K121544DYNASTY BIOFOAM SHELL
  586. K961243OCUSYSTEM ART ADVANTAGE
  587. K990228GUTHRIE PRIME POWDER-FREE
  588. K910500HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
  589. K033532ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
  590. K211078Progreat Lambda
  591. K203725S.I.N. Dental Implant System
  592. K945170QUIK-STITCH
  593. K923643MEDICOOL
  594. K803078SIMPLICITY INFUSION PUMP MODEL 2100A
  595. K090043AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
  596. K122203TRUETOME
  597. K880288TRU-TRAC TORQUE GUIDEWIRE
  598. K770204CEMENT EXTRACTOR DRILL
  599. K840398INLINE FOAM NOSE
  600. K853282CENTRIX RIBBON TUBES
  601. K052060OPTI-AMP DC-POWERED
  602. K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
  603. K993805NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)
  604. K951025PISTON SYRINGE
  605. K994032FLUORO-TEX CARDIOVASCULAR PATCH
  606. K113200VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
  607. K131081CYBER TM FAMILY
  608. K843930IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
  609. K102355ZIP'R MANTIS POWERED WHEELCHAIR
  610. K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
  611. K113338MEDICAL AIR COMPRESSOR
  612. K880435PROFORMA/PS TOTAL HIP SYSTEM
  613. K212322Cellvizio I.V.E. system with Confocal Miniprobes
  614. K955758INDIGO MEDICAL MODEL IDL 830E
  615. K052895FOURSIGHT VIEWTOOL IMAGE VIEWER
  616. K970773POWDER-FREE EXAM GLOVES
  617. K842146HISTOPAQUE-1077
  618. K791820I.P.P.B. MANIFOLDS & NEB. SING. & DBL
  619. K800838ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.
  620. K220575MAGNETOM Free.Max, MAGNETOM Free.Star
  621. K112478VISI MOBILE MONITORING SYSTEM
  622. K233380TRIDENT Mobile Fluoroscopy System
  623. K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
  624. K850892SOMATOMEDIN C BY RADIOIMMUNOASSAY
  625. K232767Nautilus VF ECMO Oxygenator
  626. K870542VASCATH VASCULAR CATHETER PLACEMENT KIT
  627. K841638ALINE ORTHODONTIC ARCHWIRE
  628. K820581NORTON JUGULAR KITS
  629. K093422VITAL SYNC MODEL 5000 SERIES
  630. K001421ONTRAK TESTCUP 501, MODEL 3016633
  631. K120524SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
  632. K192190Solax Electric Scooter
  633. K771862TRANSFUSION BLOOD FILTER
  634. K230695APRO 70 Catheter and Alembic Aspiration Tubing
  635. K833297BRONCHOSCOPY TUBE W/ULTRA LOCUFF
  636. K172165Q-Fix Suture Anchor
  637. K112055AMSCO CHIMERON MEDIUM STEAM STERILIZER
  638. K200419Kalera Vacuum Aspiration Catheter (K-VAC)
  639. K904352CODMAN COLLINS RADIOPARENT STERNAL BLADES
  640. K830319AUTO PREP
  641. K903973GARDOSI BIRTHING CUSHION
  642. K791878RIONET HEARING AID HB-64C
  643. K760395PHOTOMETER, SEROMETER (MODEL 380)
  644. K781436DELTA TEST ASSAY, HDL CHLORESTEROL
  645. K932761SOFT-WEAR HEADGEAR AND SAFETY MODULES
  646. K964952VERIDOSE V (FIVE), MODEL NUMBER 37-705
  647. K261312Temporary Keratoprosthesis (QuickSet TKP™)
  648. K241603Powered Wheelchair (NXN20-208, NXN20-211)
  649. K052481BD VIPER SYSTEM
  650. K781822ELECTRODE, MODEL 030-324
  651. K070691BBL CHROMAGAR 0157
  652. K831372TLS SURGICAL MARKER
  653. K860852SAPPHIRE BLADE SURGICAL KNIFE
  654. K042735N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
  655. K810217NEBULIZER HEATER
  656. K171957MaxZero Extension Sets with Needless Connector
  657. BK070029Tubes, Vials, Systems, Serum Separators, Blood Collection
  658. K041897MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
  659. K952685BRANEMARK SYSTEM DRILLS AND COUNTERSINKS
  660. K130038POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
  661. K965135LIFECORE CONICAL ABUTMENT
  662. K861379MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
  663. K970865ISG FAMILY OF VIEWING WANDS
  664. K233549Tempus ECG-AF
  665. K201469Mini Spike Plus 6/8R
  666. K884182SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL
  667. K942112KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
  668. K915299COGAN CORP KITS OF DENTAL HAND INSTRUMENTS
  669. K9053801-CUT ACL GRAFT KNIFE
  670. K031448RSV (RADIOLOGY SYSTEM VISIODENT
  671. K163322TZ SKULL PIN Adult
  672. K9344432:1 INPUT COMPRESSION
  673. K87515560 ML RESERVOIR BAG, ITEM #200
  674. K873737NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY
  675. K951191FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
  676. K905739ZIMMER CERAMIC FEMORAL HEADS
  677. K902202DMA TRIGLYCERIDE (GPO) PROCEDURE
  678. K103091LANX SPINAL FIXATION SYSTEM
  679. K040200MESACUP-2 TEST CENP-B
  680. K792110CONPHAR FACE MASK-STERILE
  681. K070183KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
  682. K143091Surgisleeve Wound Protector
  683. K161209Cirona 6400
  684. K800704C-DAK TM 2800 ARTIFICIAL KIDNEY
  685. K843733API UNISCEPT KB
  686. K110206AESCULAP- MEITHKE SHUNT SYSTEM
  687. K110765FXA (TM)
  688. K964421REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
  689. K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED…
  690. K933496MAXIMA FILTERED HARDSHELL RESERVIOR
  691. K151286OPTIS Integrated System Mobile Workstation
  692. K133975MSA100 PEAK FLOW METER
  693. K101016ANS SYSTEM
  694. K782116KETOSTEROID TEST, HYCEL-17
  695. K183666EBA One Nailing System
  696. K933715BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
  697. K102906FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
  698. K071184SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
  699. K112957HI-TORQUE POWERTURN
  700. K231472Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
  701. K823643INFLATABLE PILLOW
  702. K990899HEMOCHEK-A1C SAMPLE COLLECTION KIT
  703. K861758CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
  704. K220518SKANRAD 400
  705. K901399POWERBASE II (PB2)
  706. K941435BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD
  707. K861184PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
  708. K780664SOFT LENS REMOVER/INSERTER/MANIPULATOR
  709. K050872ACCU-CHEK INTEGRA SYSTEM
  710. K254046BosCATH Support Catheter
  711. K232795Led Mask Platinum Exclusive MD
  712. K242192Disposable Sphincterotome
  713. K862385SCHEIN BLEACHING UNIT
  714. K874354AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
  715. K781761KENDRICK EXTRICATION DEVICE
  716. K945089SENTRY TOTAL HIP
  717. K013618INTRAORAL MANDIBULAR DISTRACTION SYSTEM
  718. K040825LAKE REGION HYDROPHILIC GUIDEWIRE
  719. K000114RS-4M+MUSCLE STIMULATOR
  720. K213116Everyway Incontinence Stimulation System
  721. K881529CARY AND BLAIR TRANSPORT MEDIUM
  722. K915360LAPAROSCOPIC SNARE POUCH
  723. K913388THE PAN.OPTX SPORTGLASS
  724. K873492BSK-1033 TELEMETRY MONITORING CABLE
  725. K061719DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR…
  726. K192940CoolTone
  727. K895800ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
  728. K982028FLUOROSPOT COMPACT
  729. K100433IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL…
  730. K891375IQ ALBUMIN
  731. K984473LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
  732. K861166OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER
  733. K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS…
  734. K884815SLT CLMD CONTACT LASER
  735. K882951CO2 SURGICAL LASER SYSTEM MODEL #IR105
  736. K130525OCCLUSION PERFUSION CATHETER
  737. K212913Surgical Face Mask
  738. K240333Wearable Digital Thermometer (T31)
  739. K163509XprESS ENT Dilation System
  740. K163495AdvanCE capsule endoscope delivery device
  741. K940228BOUFFANT CAP
  742. K900049APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
  743. K790855SURGICAL DRAPE CLIP #201
  744. K180367Ureterorenoscope System
  745. K173634CELERITY 20 Steam Biological Indicator
  746. K102467UTA AND UHA
  747. K133604ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
  748. K111524MP 719
  749. K200965XR-MX/1000
  750. K024113IVD CRYPTO/GIARDIA DFA
  751. K922500PSL TOTAL HIP REPLACEMENT SYSTEM
  752. K945018PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL
  753. K022475MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE…
  754. K061135MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
  755. K991869COBREX HIP STEM, MODEL 01-128-XXXXX
  756. K800562DISPOSABLE HAND HELD NEBULIZER
  757. K042767DATAPRO CLINICAL CHELISTRY ANALYZER
  758. K884951TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT
  759. K091023METAMORPHOSIS
  760. K052544PULSE OXIMETER ADAPTER CABLES
  761. K190985BAROnova Insufflation System, BAROnova Accessory Kit
  762. K792105CRITIKON DUAL CHANNEL RECORDER
  763. K885226TECHNICON AXON(TM) SYSTEM
  764. K181011AIM2
  765. K900893CARDIOVUE CFS-100
  766. K871888DIGITAL FEVER THERMOMETER MODEL MC-5
  767. K123027CAPSTONE(R) SPINAL SYSTEM
  768. K801206EMIT VALPROIC ACID CONTROL
  769. K121327DIOLASE 10S
  770. K023490DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A…
  771. K850982CTAPI - NEISSERA SCREEN
  772. K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
  773. K053500FRAMELESS RADIOSURGERY COMPONENTS
  774. K901783AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
  775. K160386ReadeR, VieweR, QuickScan PSP
  776. K031024MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
  777. K133273LIGER MEDICAL ESU-110
  778. K934793SCIMED MAVERICK
  779. K844642ACCULEVEL THEOPHYLLINE TEST
  780. K143202ANGIO-PRESS DVT Compression Device Model Name: IPCS
  781. K110972POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
  782. K013705ACT III VENTRICULAR CATHETER
  783. K081851NEOSS ACCESS ABUTMENTS
  784. K823640BATH TUB SAFETY BAR
  785. K792346TWO MINUTE PROTEINTEST
  786. K984213NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
  787. K792250CUTTER POINTS
  788. K982904ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS
  789. K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
  790. BK070001Blood Establishment Computer Software and Accessories
  791. K812820CHANG MEDIUM
  792. K200416Boston One Step Liquid Enzymatic Cleaner
  793. K831060TRICHROME STAIN
  794. K020435WOUND PROTECTOR/RETRACTOR
  795. K923612MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
  796. K051905UROPLASTY RIGID ENDOSCOPIC NEEDLE
  797. K870664GUIDE WIRE
  798. K811647SALMONELLA-SHIGELLA AGAR
  799. K010429ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
  800. K863683BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
  801. K922667MIC LOW PROFILE GASTROSTOMY TUBE
  802. K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
  803. K000590LATERAL PIVOT INSERT
  804. K964815AP-4000, AIR PULSE SENSORY STIMULATOR
  805. K973673QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES
  806. K884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
  807. K882204RESUSCITATOR VALVE ASSEMBLY W/FILTER
  808. K932215COWBOY III
  809. K150473FlexPointer 1.5 mm
  810. K861523STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)
  811. K781274GAMMA MED II
  812. K150183ApexM
  813. K123998QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
  814. K201860Elos Accurate Hybrid Base
  815. K093908CCPOINT
  816. K935655ABL5 BLOOD GAS SYSTEM
  817. K193523ArthrexVIP Web Portal
  818. K831819OXYGEN CONCENTRATOR RESPIRATORY SUPPOR
  819. K181095RF-Relief
  820. K242643CapsoCam Plus (SV-3) Capsule Endoscopy System
  821. K926172SERIES 1500 DEFIBRILLATOR, MODIFICATION
  822. K900086HEMORRHOIDAL LIGATOR WITH SUCTION
  823. K212400SONON Ultrasound Imaging System, Model: SONON 500L
  824. K002218NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
  825. K211427CREOKORREKT Aligners
  826. K080769INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
  827. K190466PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use…
  828. K141069Lung Density Analysis
  829. K243979Aptiva APS IgA Reagent
  830. K892919LATEX DISPOSABLE EXAMINATION GLOVES
  831. K963800IL SYNTHESIS
  832. K761276DENTAL STOOL
  833. K070629FLEX AND LOOP COIL SET 1.5 T
  834. K031700MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
  835. K051252MICROPUMP MP-101
  836. K140871AXERA 2 ACCESS SYSTEM
  837. K001986SURGITRON IEC II
  838. K103558SYNTHES SCOUT VESSEL GUARD
  839. K890688ADX TM PHENCYCLIDINE
  840. K852464HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
  841. K792262GENTAMICIN LIQUID CONTROL SERUM
  842. K192246Biowy PICC Catheter S Kit
  843. K140607AAP LOQTEC(R) OLECRANON PLATE
  844. K130455430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
  845. K951052WEEKS APPLICATOR
  846. K812834CREATININE REAGENT SET
  847. K151236MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect…
  848. K170664Odyssey Micro Catheter
  849. K253499Ascent3T Neonatal Magnetic Resonance Imaging System
  850. K963159CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
  851. K101735ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
  852. K022413LUNEAU 3 MIRROR LENS
  853. K931698KINGS BAY PRELUDE ONE STEP HCG COMBO KIT
  854. K173274Ceevra Reveal 2.0
  855. K801213CONCEPT ENDOTRACHEAL TUBE
  856. K172273308nm Excimer System
  857. K921336TROCAR GRASPER/ANVIL APPROXIMATOR
  858. K132614PEREGRINE CURVED ILLUMINATING LASER PROBE
  859. K102813EZONO 3000
  860. K843041HESLIN DISPOS. TUBING SET
  861. K080751ARCHITECT CYCLOSPORINE
  862. K090669RIGIDFIX BIOCRYL CROSS PIN KITS
  863. K192799Glenoid Baseplate with Screw
  864. K030106STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
  865. K100604OTIS -C PLUS
  866. K021423INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
  867. K930972INTRAMEDULLARY SYSTEMS
  868. K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…
  869. K991821NITRILE EXAMINATION GLOVE, POWDERED, BLUE
  870. K223611Calibrate LTX Interbody System
  871. K802291FLUORESCENT SUN LAMP FIXTURE
  872. K200693K2 MOBILE
  873. K843115STERILE SOLUTION BOWL
  874. K133797QMASTER-H/REVO
  875. K220853PicoWay Laser System
  876. K800519HEARTWATCH
  877. K904239SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
  878. K213849SafeOp 2: Neural Informatix System
  879. K840335SHEER ENERGY PANTY HOSE
  880. K812349HAND SPLINTS & COMPONENTS
  881. K832650UPSHER FIBERBRITE LARYNGOSCOPE
  882. K021828SMALL HAMMER TOE PIN
  883. K861587WECK CONCENTRATED LIQUID CLEANER
  884. K024173CDS 3-PD HEMATOLOGY CONTROLS
  885. K972808HANSATOME MICROKERATOME
  886. K861586LOPEZ VALVE
  887. K891504PATIENT EXAMINATION GLOVE (LATEX)
  888. K951598PRO-B BIOPSY NEEDLE
  889. K113821TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
  890. K101807STAYHEALTHY BODY COMPOSITION MONITOR-BCM
  891. K854917MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
  892. K910779DISPOSABLE ELECTROSURGICAL BLADE
  893. K082079REGEN COLLAGEN SCAFFOLD (CS)
  894. K923691TWIN SILICONE CATHETER
  895. K040446ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
  896. K073115ORTHOMESH
  897. K113264ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
  898. K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
  899. K942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
  900. K961321GAMMA GUIDANCE SYSTEM
  901. K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
  902. K223776PEEK Spinal Infusion Cage
  903. K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
  904. K001068NBS CONNECTING TUBE SET
  905. K860824TSHK-NN RIA KIT
  906. K111272RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
  907. K993889EXETER CERAMIC FEMORAL HEADS
  908. K930947PROMENADE
  909. K802479SURGICAL KNIVES & PROBES
  910. K973301ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
  911. K923908# 9455 AND #9457 POOLE TIP SUCTION PROBE
  912. K893384ARGENCO 83 TYPE I DENTAL GOLD ALLOY
  913. K071093SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
  914. K910679GENESIS I AUTOMATED CELL COUNTER
  915. K142138ISO-GARD MASK
  916. K903709SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH
  917. K884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET
  918. K791876RIONET HEARING AID HB-32
  919. K821713POROCOAT LOW PROFILE METAL BACKED CUP
  920. K003039GOLD CORE II
  921. K896435HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
  922. K926499SHUTTLE SC-140
  923. K760258BITE STICK, DYNA
  924. K063544MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
  925. K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
  926. K211596CD Horizon Spinal System
  927. K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…
  928. K162339Scenium
  929. K863074TOTAL PROTEINS
  930. K944999SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
  931. K253488iFuse INTRA Ti™ Implant System
  932. K202537ALTMS Magnetic Stimulation Therapy System
  933. K131132PELVIS II IMPLANT SYSTEM
  934. K823478SCENTED MENSTRUAL PADS
  935. K960470NEURO-PATCH
  936. K820006ZEON COMPOSITE RESIN SYSTEM
  937. K901064MONOHAEM (FECAL OCCULT BLOOD TEST)
  938. K771877DIGOXIN RIA KIT
  939. K050445AMS COLLAGEN DERMAL MATRIX
  940. K001655PERMLASTIC 2
  941. K000090GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
  942. K242123Brainomix 360 e-CTA
  943. K041969AURORA DS
  944. K790560ROLLCHAIR, ORTHO BUCKET SEAT
  945. K880483V-TREND STREP A TEST
  946. K852075SITE-MALIS BIPOLAR COAGULATOR MODULE
  947. K173603Monarch Airway Clearance System
  948. K161624MicrO2 OSA Device with Micro-Recorder
  949. K171139LaparoLight Veress Needle
  950. K812808BBL DIRECTIGEN TEST KIT
  951. K992617HEX BUTTON
  952. K852003IP ACID REAGENT IP MOLY BDATE REAGENT
  953. K823068MEDISYSTEMS FISTULA NEEDLES
  954. K252647Tapestry Biointegrative Implant
  955. K863725CATARACT DIAMOND KNIFE
  956. K100992NEURALMAS
  957. K253614EchoNavigator R5.0
  958. K020892ACIST GENTOO CONTRAST INJECTION SYSTEM
  959. K902535SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM
  960. BK100030Blood Establishment Computer Software and Accessories
  961. K962863KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
  962. K093500POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
  963. K931237ENDOPATH* DISPOSABLE INTRODUCER
  964. K810384INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC
  965. K834345IM-CHECK
  966. K944308JAMES LECKEY FREE STANDER
  967. K121557WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
  968. K052573STARDUST II
  969. K242794ONCOZENE Microspheres
  970. K110633LANCER PEDICLE SCREW SYSTEM
  971. K903656PATIENT EXAMINATION GLOVES
  972. K191088Checkme O2 Pulse Oximeter
  973. K173183CEDIA Heroin Metabolite (6-AM) Assay
  974. K922388WATERS(TM) LC MODULE I FOR CLINICAL USE
  975. K792114EMIT-BARBITURATE ASSAY
  976. K093393LIFEDOP MODEL 300ABI
  977. K837336VERASUN RADIATION THERAPY SIMULATION SYSTEM
  978. K002645JEL BIOS PURE
  979. K943777SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER
  980. K80236912SSL ECG ANALYSIS PROG.(SCALER LEAD)
  981. K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY
  982. K965226EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
  983. K170221syngo.CT Cardiac Planning
  984. K833387ARGON LASER SURGICAL SYSTEM 770
  985. K171541Powder Free Nitrile Examination Gloves (Orange)
  986. K083279CALTRIX RESORBABLE BONE VOID FILLER
  987. K061573TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
  988. K042909STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
  989. K911644NGM FRAME
  990. K971412SUNGLASSES
  991. K841493MODEL 1000 APC-ANGIOPLASTY PRESSURE
  992. K122468ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM…
  993. K071937BONALIVE GRANULES AND BONALIVE PLATES
  994. K990428DRAINAGE BAG
  995. K172300CoLink View Plating System
  996. K900565INVACARE POWER 9000 SERIES WHEELCHAIR
  997. K041465SINON SN-L402 LIGHTWEIGHT WHEELCHAIR
  998. K922716SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509
  999. K190708AccelFix Lumbar Interbody Fusion Cage System
  1000. K851702MORTARA INSTRUMENT MODEL EL-1

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