FDA 510(k) clearances — page 965

176,637 clearances on record, most recent first.

Clearances — page 965

96,401–96,500 of 176,637

K964575 — SYMPACATH HYDROGEL COATED FOLEYRusch Intl.·Product code EZL·1997-02-04
K964608 — MRT-35A V9.0Toshiba America Mri, Inc.·Product code LNH·1997-02-04
K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.·Product code LFW·1997-02-04
K964691 — TCB TEMPORARY CROWN AND BRIDGE MATERIALScican·Product code EBG·1997-02-04
K964720 — VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)Johnson & Johnson Clinical Diagnostics, Inc.·Product code CGJ·1997-02-04
K964771 — DE-TOX CONTROL 1 AND DE-TOX CONTROL 19Dyna-Tek Industries·Product code DIF·1997-02-04
K964864 — PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAYAlexon Biomedical, Inc.·Product code LLH·1997-02-04
K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)Gynecare Innovation Center·Product code FJL·1997-02-04
K964914 — ALKALINE PHOSPHATASEDerma Media Lab., Inc.·Product code CJE·1997-02-04
K965047 — MINK LUNG CELL CULTURENeogenex·Product code KIR·1997-02-04
K965159 — CETIBUTEN, 30MCG, SENSI-DISCBecton Dickinson Microbiology Systems·Product code JTN·1997-02-04
K965166 — STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)Specialized Assays, Inc.·Product code JJT·1997-02-04
K965168 — STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)Specialized Assays, Inc.·Product code JJT·1997-02-04
K965184 — PERFECTA PREGNANCY TESTWyntek Diagnostics, Inc.·Product code LCX·1997-02-04
K965227 — OSOM CLASSIC HCG-URINE TEST (115)Wyntek Diagnostics, Inc.·Product code JHI·1997-02-04
K962468 — HEDROCEL ACETABULAR RESTRICTORImplex Corp.·Product code JDI·1997-02-03
K962942 — TOTALCAREHill-Rom, Inc.·Product code FNL·1997-02-03
K963248 — FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)J-Lloyd Medical, Inc.·Product code DYG·1997-02-03
K963671 — OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUPOsteonics Corp.·Product code JDI·1997-02-03
K964028 — SYS STIM 226Mettler Electronics Corp.·Product code IPF·1997-02-03
K964137 — RTA RETINAL THICKNESS ANALYZERTalia Technology , Ltd.·Product code HLI·1997-02-03
K964426 — SMARTOAEIntelligent Hearing Systems·Product code EWO·1997-02-03
K964468 — IAMIN WET DRESSING (COPPER-SALINE)Procyte Corp.·Product code MGQ·1997-02-03
K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTBiologically Oriented Prostheses·Product code KYI·1997-02-03
K964532 — MULTITAK SS SUTURE SYSTEMBonutti Research·Product code MBI·1997-02-03
K964662 — FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15Rmds, Inc.·Product code DXC·1997-02-03
K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTORStorz Instrument Co.·Product code HQE·1997-02-03
K964851 — ENTRACARE THERMOMTER MODEL 1000Entracare Corp.·Product code FLL·1997-02-03
K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)Mekanika, Inc.·Product code LBB·1997-02-03
K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEMConceptus, Inc.·Product code MKO·1997-01-31
K963580 — IMAGYN FALLOPOSCOPY SYSTEMImagyn Medical, Inc.·Product code MKO·1997-01-31
K963765 — STRYKER STRYKEFLOW ELECTROCAUTERY PROBESStryker Endoscopy·Product code GEI·1997-01-31
K964371 — SHUNT TAP WITH ICP MONITORING ACCESS PORTIntegra Neurocare, LLC·Product code JXG·1997-01-31
K964386 — RADIONICS CONTOUR FLEX PLUS VALVERadionics, Inc.·Product code JXG·1997-01-31
K964390 — CHASE VESSEL OCCLUDERChase Medical, Inc.·Product code MJN·1997-01-31
K965060 — ULTRA-ETCH STATUltradent Products, Inc.·Product code EBF·1997-01-31
K953938 — STERILEMAXBarnstead/Thermolyne Corp.·Product code FLE·1997-01-30
K954674 — P1OP2B OR P1O92TKay Borch A/S·Product code FYA·1997-01-30
K961521 — PATIENT EXAMINATION GLOVEShanghai PT Plastics Enterprise Company, Ltd.·Product code LYZ·1997-01-30
K961975 — DISETRONIC D-MODEMDisetronic Medical Systems·Product code FRN·1997-01-30
K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVERPinnacle Products, Inc.·Product code MMP·1997-01-30
K962813 — DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVESMaxxim Medical·Product code KGO·1997-01-30
K963764 — SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEARSpecialty Ultravision, Inc.·Product code LPL·1997-01-30
K964041 — CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSISRobert R. Stevens·Product code KOC·1997-01-30
K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVERContour Fabricators, Inc.·Product code MOS·1997-01-30
K964363 — BIPAP DUET SYSTEMRespironics, Inc.·Product code BZD·1997-01-30
K964367 — CES VASCULAR OCCLUSION SYSTEMCordis Neurovascular, Inc.·Product code HCG·1997-01-30
K964436 — WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEMWestern Surgical Instrument Co.·Product code HET·1997-01-30
K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.·Product code DWS·1997-01-30
K964455 — POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333Medtronic Minimed·Product code FPA·1997-01-30
K964456 — POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367Medtronic Minimed·Product code FPA·1997-01-30
K964529 — CW ACUPUNCTURE NEEDLESLhasa Medical, Inc.·Product code MQX·1997-01-30
K964612 — VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINTVistakon, Johnson & Johnson Vision Products, Inc.·Product code LPL·1997-01-30
K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660U.S. Imaging Tables, Inc.·Product code IXR·1997-01-30
K970016 — VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)Johnson & Johnson Clinical Diagnostics, Inc.·Product code CDP·1997-01-30
K970146 — ELECSYS CALCHECK TESTOSTERONEBoehringer Mannheim Corp.·Product code JJX·1997-01-30
K922668 — PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEMColin Medical Instruments Corp.·Product code MHX·1997-01-29
K955802 — PATHFINDERCardima, Inc.·Product code DRF·1997-01-29
K955847 — GYRO TIP EP CATHETERCardiac Assist Devices, Inc.·Product code DRF·1997-01-29
K961346 — PH ANALYSIS MODULESynectics-Dantec·Product code FFT·1997-01-29
K961897 — WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLEWilson-Cook Medical, Inc.·Product code FCG·1997-01-29
K962291 — SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEMSiemens Medical Solutions USA, Inc.·Product code DSI·1997-01-29
K964366 — EAGLE EYESMech-Tronic Precision Mfg., Ltd.·Product code HQY·1997-01-29
K964379 — KSEA PUNCTURE CANNULAKARL STORZ Endoscopy-America, Inc.·Product code HET·1997-01-29
K964564 — SUNGLASSESMicron Metal & Plastic Manufactory Co.·Product code HQY·1997-01-29
K964744 — SENNATrans-America Enterprises Corp.·Product code HQY·1997-01-29
K962689 — COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP)Cobe Cardiovascular, Inc.·Product code CAC·1997-01-28
K963067 — SOF. PRESS EPC 51 SYSTEMGaymar Industries, Inc.·Product code JOW·1997-01-28
K964352 — TORQUE DEVICEB.Braun Medical, Inc.·Product code DQX·1997-01-28
K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.·Product code CBH·1997-01-28
K964611 — TRANSEND GUIDEWIREBoston Scientific Corp·Product code DQX·1997-01-28
K964919 — EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEMEmerald Medical, Inc.·Product code HRX·1997-01-28
K965061 — VIDAMED MODEDL 7600 RF GENERATORVidamed, Inc.·Product code GEI·1997-01-28
K965067 — DILATION CATHETER, BALLOONBoston Scientific Corp·Product code GBM·1997-01-28
K970056 — SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIESWoodbine Optical Corp.·Product code GCJ·1997-01-28
K961560 — ECLIPSE 2000Cardiogenes·Product code GEX·1997-01-27
K962654 — COMPLEAT SURGICAL MASKCarl Parker Associates, Inc.·Product code FXX·1997-01-27
K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERSAmerican Diagnostic Corp.·Product code DXQ·1997-01-27
K962854 — HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECTCardio Control BV·Product code LOS·1997-01-27
K963509 — GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONSmith & Nephew Richards, Inc.·Product code LPH·1997-01-27
K963675 — THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPEMicro-Medical Devices, Inc.·Product code KKX·1997-01-27
K963929 — JOBST ATHROMBIC PUMP SYSTEM 2100Jobst A Beiersdorf Co.·Product code JOW·1997-01-27
K963946 — OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)Osteonics Corp.·Product code LPH·1997-01-27
K963998 — METAL BACKED ACETABULAR COMPONENTEncore Orthopedics, Inc.·Product code LPH·1997-01-27
K964280 — DG NERVUSMedelec , Ltd.·Product code GWQ·1997-01-27
K964357 — NATURAL-HIP SYSTEM COCR STEMIntermedics Orthopedics·Product code LZO·1997-01-27
K964384 — MODEL D-290P ADMINISTRATION SETPatient Solutions, Inc.·Product code FPA·1997-01-27
K964395 — PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENTHayes Medical, Inc.·Product code LZO·1997-01-27
K964414 — LR 5200 LASER FILM RECORDERBayer Corp., Agfa Div.·Product code LMC·1997-01-27
K964433 — AQUABOND ELECTRODEMedibond , Ltd.·Product code GXY·1997-01-27
K964675 — H.PYLORI CONTROLSPyramid Biological Corp.·Product code LYR·1997-01-27
K964685 — DYNAMOMETERJohn Chatillon & Sons, Inc.·Product code LBB·1997-01-27
K964761 — S.A.M. FACIAL IMPLANT W/INTRODUCERW. L. Gore & Associates, Inc.·Product code FTL·1997-01-27
K965048 — VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)Johnson & Johnson Clinical Diagnostics, Inc.·Product code JJY·1997-01-27
K965049 — DAHLBERG (A-554)Miracle-Ear, Inc.·Product code ESD·1997-01-27
K965057 — AUDIOTONE (A554H)Miracle-Ear, Inc.·Product code ESD·1997-01-27
K965063 — AUDIOTONE (A-552)Miracle-Ear, Inc.·Product code ESD·1997-01-27
K965072 — PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNITKaycor Intl., Ltd.·Product code EHD·1997-01-27
K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLESU.S. Imaging Tables, Inc.·Product code IXR·1997-01-27
K970059 — KODAK MINILOADER(2000)Eastman Kodak Company·Product code IXW·1997-01-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.