FDA 510(k) clearances — page 951

176,637 clearances on record, most recent first.

Clearances — page 951

95,001–95,100 of 176,637

K971204 — LSVP INTERNATIONAL HOT BIOPSY FORCEPSLsvp Intl., Inc.·Product code KGE·1997-05-27
K971212 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018Alexander Mfg. Co.·Product code MRZ·1997-05-27
K971213 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-PAlexander Mfg. Co.·Product code MRZ·1997-05-27
K971234 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825Alexander Mfg. Co.·Product code MRZ·1997-05-27
K971237 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108Alexander Mfg. Co.·Product code MRZ·1997-05-27
K971312 — IMMULITE PYRILINKS-DDiagnostic Products Corp.·Product code JMM·1997-05-27
K971477 — UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)Trace America, Inc.·Product code CDQ·1997-05-27
K971485 — URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.·Product code CDO·1997-05-27
K971777 — QUANTEX ASO-CRP-RF CONTROLInstrumentation Laboratory CO·Product code JJT·1997-05-27
K963738 — STELA MODEL BJ44 AND BJ45 PACING LEADSEla Medical, Inc.·Product code DTB·1997-05-23
K963779 — RUSCH ENTERAL FEEDING TUBERusch, Inc.·Product code FPD·1997-05-23
K963803 — CENTOCOR CA 15-3 RIA MODEL NO. 800-033Centocor, Inc.·Product code MOI·1997-05-23
K964251 — OCCLUSION CLAMP** DEVICEUnited States Surgical, A Division of Tyco Healthc·Product code DXC·1997-05-23
K964337 — BETTER-BLADDER (BB)Circulatory Technology, Inc.·Product code FIB·1997-05-23
K964718 — STA D-DI CALIBRATOR KITAmerican Bioproducts Co.·Product code DAP·1997-05-23
K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)Utah Medical Products, Inc.·Product code KPI·1997-05-23
K970890 — #ES-32 SUCTION CATHETER 32 FR.Tri-Med Specialties, Inc.·Product code KNT·1997-05-23
K970933 — AUTO HDL CHOLESTEROL CALIBRATORPointe Scientific, Inc.,·Product code JIS·1997-05-23
K971100 — ATRION MEDICAL AUTOGENOUS TISSUE COLLECTORAtrion Medical Products, Inc.·Product code EIA·1997-05-23
K971125 — ENDO SMARTCAP (100501)Endo Smart Cap Co.·Product code OCX·1997-05-23
K971275 — MILL-ROSE DISPOSABLE POLYPECTOMY SNAREMill-Rose Laboratory·Product code FDI·1997-05-23
K971333 — SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYDBeckman Instruments, Inc.·Product code JIX·1997-05-23
K971415 — VINYL PATIENT EXAMINATION GLOVE, POWDER-FREEShanghai Foremost Plastic Industrial Co., Ltd.·Product code LYZ·1997-05-23
K971423 — VINYL PATIENT EXAMINATION GLOVE, POWDEREDShanghai Foremost Plastic Industrial Co., Ltd.·Product code LYZ·1997-05-23
K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)Clarus Medical Systems, Inc.·Product code OCV·1997-05-23
K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. Geller·Product code DBL·1997-05-23
K962939 — VECTORVISIONBrainlab, Inc.·Product code HAW·1997-05-22
K963369 — BIO-ANCHORLinvatec Corp.·Product code MAI·1997-05-22
K965143 — OSMOCYTE WOUND MANAGER SHEET DRESSINGProcyte Corp.·Product code MGQ·1997-05-22
K970257 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURESFerguson Medical·Product code HSB·1997-05-22
K970258 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURESFerguson Medical·Product code HRS·1997-05-22
K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURESFerguson Medical·Product code HSB·1997-05-22
K970605 — 3-CCD DIGITAL CAMERAEnvision Medical Corp.·Product code GCJ·1997-05-22
K970672 — CRYSTAL-EEG MODEL 10 (MODEL 10)Cleveland Medical Devices, Inc.·Product code OMC·1997-05-22
K970705 — INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLESSulzer Orthopedics, Inc.·Product code LPH·1997-05-22
K970706 — INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLESSulzer Orthopedics, Inc.·Product code LPH·1997-05-22
K970758 — DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATEHowmedica Corp.·Product code JWH·1997-05-22
K970900 — INSTRUMENT HOLDERContour Fabricators, Inc.·Product code GCJ·1997-05-22
K970993 — DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLEDeroyal Industries, Inc.·Product code GEI·1997-05-22
K970997 — NEO-CARE LUMBER PUNCTURE KITKlein-Baker Medical, Inc.·Product code MIA·1997-05-22
K971025 — AYURVEDIC TONGUE CLEANERCalello Martinez P.C.·Product code LCN·1997-05-22
K971155 — MEMOREGHeraeus Kulzer, Inc.·Product code ELW·1997-05-22
K971173 — ML DISPOSABLE ALK TUBINGMed-Logics, Inc.·Product code KYG·1997-05-22
K971269 — DSL ACTIVE T4 EIADiagnostic Systems Laboratories, Inc.·Product code KLI·1997-05-22
K971270 — DSL ACTIVE T3 EIADiagnostic Systems Laboratories, Inc.·Product code CDP·1997-05-22
K971319 — NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom Dental·Product code EKS·1997-05-22
K971341 — KIRWAN MODEL 28 1000 BIPOLAR COAGULATORKirwan Surgical Products, Inc.·Product code GEI·1997-05-22
K971422 — OSTEONICS ACETABULAR WEDGE SYSTEMOsteonics Corp.·Product code MEH·1997-05-22
K971430 — PROSPORE IIRaven Biological Laboratories, Inc.·Product code FRC·1997-05-22
K971548 — AMBUVACKinetic Concepts, Inc.·Product code OMP·1997-05-22
K971613 — SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBINGTechnical Products, Inc.·Product code MIB·1997-05-22
K963254 — SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEMBoston Scientific Corp·Product code FGE·1997-05-21
K964329 — UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)Richard Wolf Medical Instruments Corp.·Product code GEI·1997-05-21
K964506 — ROCHE COBAS AMPLICOR ANALYZERRoche Molecular Systems, Inc.·Product code JJF·1997-05-21
K964551 — CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUIDScimed Life Systems, Inc.·Product code DQX·1997-05-21
K964635 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KITNichols Institute Diagnostics·Product code JKR·1997-05-21
K964922 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEMAlthin Medical AB an Affiliate of Baxter Intl·Product code KDI·1997-05-21
K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)Quinton, Inc.·Product code DQA·1997-05-21
K965094 — HYCOR ALLERGEN DISCHycor Biomedical, Inc.·Product code DHB·1997-05-21
K965133 — ANCA COMBI DIAGNOSTIC TEST KITThe Binding Site, Ltd.·Product code MOB·1997-05-21
K970189 — FIF TMPanbio, Inc.·Product code KQJ·1997-05-21
K970642 — TENOSCOPELuxtec Corp.·Product code HRX·1997-05-21
K970871 — TR NEEDLEGallini Intl., Inc.·Product code KNW·1997-05-21
K970872 — PAN (CHIBA ASPIRATING NEEDLE)Gallini Intl., Inc.·Product code KNW·1997-05-21
K970883 — CEDIA DIGOXIN IIBoehringer Mannheim Corp.·Product code KXT·1997-05-21
K970919 — SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENTBeckman Instruments, Inc.·Product code KNK·1997-05-21
K970948 — 800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIESLaserscope·Product code GEX·1997-05-21
K971049 — FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)Aspect Vision Care, Ltd.·Product code LPL·1997-05-21
K971164 — FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENSAspect Vision Care, Ltd.·Product code LPL·1997-05-21
K971174 — PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONSPlaytex, Inc.·Product code HEB·1997-05-21
K971526 — ACE HDL-C REAGENTSchiapparelli Biosystems, Inc.·Product code LBS·1997-05-21
K971534 — SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROLBeckman·Product code DIF·1997-05-21
K945590 — SCOPETEX(TM)Smith Helms Mulliss & Moore, L.L.P.·Product code CCW·1997-05-20
K962009 — UROSTYMLaborie Medical Technologies, Ltd.·Product code KPI·1997-05-20
K962899 — ULTRAFLEX DIAMONDBoston Scientific Corp·Product code FGE·1997-05-20
K963781 — ZOLL AUTOCLAVABLE INTERNAL HANDLESZoll Medical Corp·Product code LDD·1997-05-20
K964702 — EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800Euclid Systems Corp.·Product code MMQ·1997-05-20
K964868 — 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETERMicro Therapeutics, Inc.·Product code KRA·1997-05-20
K970466 — RADIUS PTCA GUIDEWIRERadius Medical Technologies, Inc.·Product code LIT·1997-05-20
K970647 — OUR ROTATING GAMMA SYSTEMOur Scientific Intl., Inc.·Product code IWB·1997-05-20
K970690 — LOCKING STYLET 2Cook Pacemaker Corp.·Product code DQX·1997-05-20
K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.·Product code HMX·1997-05-20
K970875 — ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)American Medical Devices, Inc.·Product code MPA·1997-05-20
K970908 — HOWTEK 960Howtek, Inc.·Product code LMA·1997-05-20
K970999 — SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITORSony Medical Systems·Product code JAK·1997-05-20
K971277 — SAFE-T-CLAMPTalon Medical, Ltd.·Product code KNA·1997-05-20
K971292 — JEL-71 PDFJ.F. Jelenko & Co., Inc.·Product code EJT·1997-05-20
K971373 — VISTA SINGLE CHIP VIDEO CAMERAVista Medical Technologies, Inc.·Product code FET·1997-05-20
K971431 — UMI X-RAY FILM CASSETTEUmi Intl.·Product code IXA·1997-05-20
K971432 — PROSPORERaven Biological Laboratories, Inc.·Product code FRC·1997-05-20
K971455 — CLARUS MODEL 5197 SIGHTLITEClarus Medical Systems, Inc.·Product code FTI·1997-05-20
K971515 — PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)Biomed Devices Corp.·Product code LPL·1997-05-20
K971574 — JELBOND-PDFJ.F. Jelenko & Co., Inc.·Product code EJT·1997-05-20
K962753 — KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)Biomedical Implant Technology, Inc.·Product code DZE·1997-05-19
K963202 — MEGA ME 3000 PROFESSIONAL MUSCLE TESTERMega Electronics , Ltd.·Product code HCC·1997-05-19
K964825 — FREEDOM TRAVELLERImpact Case Technologies, Inc.·Product code MLW·1997-05-19
K970604 — VIEWPOINT - 3.0 SOFTWAREPhilips Medical Systems (Cleveland), Inc.·Product code HAW·1997-05-19
K970645 — BC THROMBIN REAGENTBehring Diagnostics, Inc.·Product code GJA·1997-05-19
K970658 — LUMBAR DRAINAGE ACCESSORY KITIntegra Neurocare, LLC·Product code JXG·1997-05-19
K970703 — GALILEO HALLEYBiosound Esaote, Inc.·Product code GWQ·1997-05-19

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