FDA 510(k) clearances — page 971

176,637 clearances on record, most recent first.

Clearances — page 971

97,001–97,100 of 176,637

K963885 — ULTIMA FX FEMORAL HIP STEMSJohnson & Johnson Professionals, Inc.·Product code KWY·1996-12-09
K963956 — PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNITSouthern Research, Inc.·Product code BYJ·1996-12-09
K964334 — EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)Shippert Medical Technologies Corp.·Product code GCJ·1996-12-09
K964458 — ELLIS EXTERNAL MINI-FIXATOR SYSTEMLink America, Inc.·Product code KTT·1996-12-09
K964500 — ACUMED TENSION BAND PINAcu Med, Inc.·Product code HTY·1996-12-09
K965256 — DMS-1000C DERMOABRADERMattioli Engineering, Srl·Product code GFD·1996-12-09
K950259 — COUPLING DEVICE FOR DENTAL PROSTHESISDr. Joseph E. Grasso, D.D.S.·Product code EGG·1996-12-06
K955073 — KSEA THERMOFLATOR (MODEL 26 4320 20)KARL STORZ Endoscopy-America, Inc.·Product code HIF·1996-12-06
K961607 — VIRAPUMP II (MODELS AND MODEL M)Viatro, Corp.·Product code FEB·1996-12-06
K962256 — GALILEO HYSTEROSCOPES AND LAPAROSCOPESGalileo Electro-Optics Corp.·Product code HIH·1996-12-06
K962969 — MEDICAL DEVICE TECHNOLOGIES, INC.ULTRAMedical Device Technologies, Inc.·Product code KNW·1996-12-06
K963276 — THE SAFETY 1ST DIGITAL PACIFIERSafety 1st, Inc.·Product code FLL·1996-12-06
K963624 — PHILIPS SLI SERIES LINEAR ACCELERATORPhilips Medical Systems, Inc.·Product code IYE·1996-12-06
K963743 — MANAN PROSTATE UNI-LOCKManan Medical Products, Inc.·Product code IWJ·1996-12-06
K963877 — AHS OMEGA CONCEPTAuthorized Hearing Systems, Inc.·Product code ESD·1996-12-06
K963878 — AHS OMEGA HFAuthorized Hearing Systems, Inc.·Product code ESD·1996-12-06
K963922 — ALPHA-DENT ROOT CANAL SEALER & FILLERWallace A. Erickson & Co.·Product code KIF·1996-12-06
K964040 — TRUBYTE SOFT RELINE SYSTEMDentsply Intl.·Product code EBI·1996-12-06
K964216 — STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKERStarkey Laboratories, Inc.·Product code KLW·1996-12-06
K964421 — REMEL MEROPENEM 10UG SUSCEPTIBILITY DISKRemel, L.P.·Product code JTN·1996-12-06
K964475 — CLINICAL BLOOD GAS MIXTURESOxarc, Inc.·Product code JIS·1996-12-06
K964566 — OZARK 20Gateway Alloys, Inc.·Product code EJT·1996-12-06
K964567 — EL DORADO 75Gateway Alloys, Inc.·Product code EJT·1996-12-06
K964568 — OZARK 46Gateway Alloys, Inc.·Product code EJT·1996-12-06
K964569 — EL DORADO 58Gateway Alloys, Inc.·Product code EJT·1996-12-06
K964572 — PALLADIA 76Gateway Alloys, Inc.·Product code EJT·1996-12-06
K964573 — PIEDMONT 70 (CH-35)Gateway Alloys, Inc.·Product code EJT·1996-12-06
K964603 — ARTICULAR HEARING AIDSDecibel Instruments, Inc.·Product code ESD·1996-12-06
K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.·Product code CCE·1996-12-05
K960389 — HYPERBARIC CHAMBERTampa Hyperbaric Ent.·Product code CBF·1996-12-05
K961530 — GISH RELIANCE OXYGENATOR (MODEL HFO)Gish Biomedical, Inc.·Product code DTZ·1996-12-05
K961633 — CD HORIZON SPINAL SYSTEMSofamor Danek USA,Inc.·Product code KWP·1996-12-05
K962203 — WHISPER SWIVEL II EXHALATION PORTRespironics, Inc.·Product code BZD·1996-12-05
K962276 — HEMAGEN ENA DSDNA KIT (EIA METHOD)Hemagen Diagnostics, Inc.·Product code DHN·1996-12-05
K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTSmith & Nephew Richards, Inc.·Product code JWH·1996-12-05
K963128 — NOVAGEL SILICONE GEL SHEETINGBrennen Medical, Inc.·Product code MDA·1996-12-05
K963770 — BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLSBiocircuits Corp.·Product code JJY·1996-12-05
K963958 — IMPRESS, PERFECTA, ACU-FORM, AND ACUFITBeltone Electronics Corp.·Product code ESD·1996-12-05
K964102 — TENET TIBIAL FRACTURE SUPPORTTenet Medical Engineering·Product code GBB·1996-12-05
K964175 — VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODESValleylab, Inc.·Product code GEI·1996-12-05
K964243 — HUMERUS WIRESCompagnie Financiere & Medicale (Cf&M)·Product code HSB·1996-12-05
K950550 — XH-1 NEUROMUSCULAR STIMULATORCalifornia Medical Research Institute·Product code IPF·1996-12-04
K952315 — SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWAREEmg Scientific·Product code DQA·1996-12-04
K962591 — FOOT WEIGHT ALARMCleveland Medical Devices, Inc.·Product code IRN·1996-12-04
K963231 — EXCEL ONESTEP URINE HCG MODULE PREGNANCY TESTExcel Scientific, Inc.·Product code JHI·1996-12-04
K963328 — AMS AMBICOR PENILE PROSTHESISAmerican Medical Systems, Inc.·Product code FAE·1996-12-04
K963558 — CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATORContemporary Products, Inc.·Product code JCX·1996-12-04
K963596 — POLAR CARE 300Breg, Inc.·Product code ILO·1996-12-04
K963621 — STETHOSTheratechnologies, Inc.·Product code DQD·1996-12-04
K963709 — CEMENT-ON FEMORAL STEMBiomet, Inc.·Product code JWH·1996-12-04
K963736 — SOFT DENTURE REBASING RESINSybron Dental Specialties, Inc.·Product code EBI·1996-12-04
K963811 — CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICECard Guard Scientific Survival , Ltd.·Product code DXH·1996-12-04
K964035 — PHONAK MICROLINK, PERSONAL FM RECEIVERPhonak, Inc.·Product code ESD·1996-12-04
K964121 — WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESISBoston Scientific Scimed, Inc.·Product code JCT·1996-12-04
K964476 — DE ORO 77Gateway Alloys, Inc.·Product code EJT·1996-12-04
K960970 — POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020PPossis Medical, Inc.·Product code MCW·1996-12-03
K963320 — TFX MEDICAL GUIDEWIRETfx Medical Group·Product code DQX·1996-12-03
K963493 — FERRITIN CALIBRATORDade Chemistry Systems, Inc.·Product code JIT·1996-12-03
K964578 — FIBREKORJeneric/Pentron, Inc.·Product code EBF·1996-12-03
K962172 — FLEXIBLE MINI-FIBERSCOPESRichard Wolf Medical Instruments Corp.·Product code FBN·1996-12-02
K963170 — OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.·Product code DBF·1996-12-02
K963341 — MIDSTREAM ONESTEP PREGNANCY HOME TESTSyntron Bioresearch, Inc.·Product code LCX·1996-12-02
K963517 — SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.·Product code FCL·1996-12-02
K963547 — THE WRAP IMMOBILIZATION SYSTEMSafe Restraints, Inc.·Product code FMQ·1996-12-02
K963705 — COLOR ENHANCEMENT FUNCTION FOR THE SSA-380AToshiba America Medical Systems, In.C·Product code IYN·1996-12-02
K963862 — TOUCH N' HEATSybron Dental Specialties, Inc.·Product code EAT·1996-12-02
K963906 — PATIENT RESTRAINTSSafety Intl., Inc.·Product code FMQ·1996-12-02
K964211 — DAVOL PLUME FILTER (5541420)Davol Inc., Sub. C. R. Bard, Inc.·Product code GEX·1996-12-02
K964477 — OZARK 40Gateway Alloys, Inc.·Product code EJT·1996-12-02
K953233 — SIMVIEW 3000 CT OPTIONSiemens Medical Solutions USA, Inc.·Product code KPQ·1996-11-29
K953591 — CEP 8 SPECTRUMORANGE DNA PROBE KITVysis·Product code OYU·1996-11-29
K962112 — NEW COMFORT CONTACT LENS CARE ACCESSORYLens Comfort, Inc.·Product code LYL·1996-11-29
K962760 — ENZYMUN-TEST FT3Boehringer Mannheim Corp.·Product code CDP·1996-11-29
K962911 — CONTACT LENS WITH COLOR ADDITIVECal Bionics·Product code LPL·1996-11-29
K962952 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)Olympus Optical, Co.·Product code LBK·1996-11-29
K963011 — LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEARPermeable Technologies, Inc.·Product code LPL·1996-11-29
K963135 — GIARDIA CELISATechlab, Inc.·Product code MHI·1996-11-29
K963693 — OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TESTPrinceton BioMeditech Corp.·Product code CEP·1996-11-29
K963724 — GAUZE SPONGE, NON X-RAY DETECTABLEGrand Medical Products·Product code EFQ·1996-11-29
K963753 — NASP TRANSPARENT DRESSINGNorth American Sterilization & Packaging Co.·Product code MGP·1996-11-29
K963763 — EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZERMedica Corp.·Product code JGS·1996-11-29
K963902 — QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.·Product code GIS·1996-11-29
K963964 — AVL COMPACT 3 PH/BLOOD GAS ANALYZERAvl Scientific Corp.·Product code CHL·1996-11-29
K963992 — CAPILLARY ADAPTOR ACCESSORYMedica Corp.·Product code CGZ·1996-11-29
K964269 — PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONSPlaytime Products, Inc.·Product code HIL·1996-11-29
K964588 — WATERS 515 HPLC PUMP (515)Waters Corporation·Product code KIE·1996-11-29
K960856 — KONSTRUCT PATELLAR COMPONENTBiomet, Inc.·Product code JWH·1996-11-27
K962061 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEMGE Medical Systems·Product code LNH·1996-11-27
K962116 — GALILEO ENDOSCOPESGalileo Electro-Optics Corp.·Product code EOB·1996-11-27
K962195 — HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3Sunbeam Health Division·Product code IRT·1996-11-27
K962217 — GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KITGen-Probe, Inc.·Product code MKZ·1996-11-27
K962481 — QUASAR RECOVERY IMAGING PACKAGETrionix Research Laboratory, Inc.·Product code KPS·1996-11-27
K962537 — INCARE HOT/ICE LITE MACHINEHollister, Inc.·Product code ILO·1996-11-27
K962569 — BIOMID BONE MARROW BIOPSY NEEDLEGallini Intl., Inc.·Product code FCG·1996-11-27
K962570 — ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLEGallini Intl., Inc.·Product code FCG·1996-11-27
K962984 — ISOLA PEDIATRIC COMPONENTSAcromed Corp.·Product code KWP·1996-11-27
K963020 — GLOVEL GXKenwell International , Ltd.·Product code KGO·1996-11-27
K963029 — KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADEKARL STORZ Endoscopy-America, Inc.·Product code HRX·1996-11-27
K963429 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEMGE Medical Systems·Product code LNH·1996-11-27
K963486 — REVISION HIP SYSTEMSmith & Nephew Richards, Inc.·Product code JDI·1996-11-27

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