FDA 510(k) clearances — page 944

176,637 clearances on record, most recent first.

Clearances — page 944

94,301–94,400 of 176,637

K961817 — B SMART MODEL 1Koven Technology, Inc.·Product code LEL·1997-07-23
K962060 — STREP A OIA MAXBiostar, Inc.·Product code GTZ·1997-07-23
K963987 — CAMOUFLAGE CUFF SAVERSN.A. Braggs Medical, Inc.·Product code DXQ·1997-07-23
K964408 — POSEIDON CARDIAC MONITORING SYSTEM (PCMS)Instromedix, Inc.·Product code DPS·1997-07-23
K965010 — TARGET 2 VERSION 1.1GE Medical Systems·Product code IYE·1997-07-23
K965198 — ULTIMA TPS CEMENTED STEMJohnson & Johnson International·Product code KWL·1997-07-23
K965247 — ENVOY GUIDING CATHETERCordis Neurovascular, Inc.·Product code DQY·1997-07-23
K971165 — INTRODUCER SHEATH AND DILATORBoston Scientific Corp·Product code LDF·1997-07-23
K971298 — BETTER HEARING, INC. MODEL L-1 HEARING AIDBetter Hearing, Inc.·Product code ESD·1997-07-23
K971387 — FREERIDER, MODEL FR510-FFreerider USA, Inc.·Product code INI·1997-07-23
K971388 — FREERIDER, MODEL FR168-4Freerider USA, Inc.·Product code INI·1997-07-23
K971516 — CORDIS POWERFLEX PLUS PTA BALLOON CATHETERCordis Corp.·Product code LIT·1997-07-23
K971532 — ARTHROCARE ELECTROSURGERY SYSTEMArthrocare Corp.·Product code GEI·1997-07-23
K971648 — SHARPLAN ERBIUM: YAG LASER (4020)Sharplan Lasers, Inc.·Product code GEX·1997-07-23
K971667 — CARDIAC PHASED ARRAY COILGE Medical Systems·Product code MOS·1997-07-23
K971669 — COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.·Product code DTN·1997-07-23
K971718 — MICRO-SEAL ACETABULAR SYSTEMWhiteside Biomechanics, Inc.·Product code LPH·1997-07-23
K971784 — ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEMZeus Scientific, Inc.·Product code MID·1997-07-23
K971843 — LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIESLaserscope·Product code GEX·1997-07-23
K971942 — SLED, FINGER, HANDLEBiosound Esaote, Inc.·Product code ITX·1997-07-23
K971943 — MYRINGOTOMY TUBEMednet Locator, Inc.·Product code ETD·1997-07-23
K971968 — SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)Remington Medical, Inc.·Product code DSA·1997-07-23
K972094 — TARGET CARDIAC TROPONIN I TESTTexas Immunology, Inc.·Product code MMI·1997-07-23
K972159 — FENWAL 40 MICRON TRANSFUSION FILTERBaxter Healthcare Corp·Product code CAK·1997-07-23
K972202 — DEEG-LITEGrass-Telefactor Product Group·Product code GWQ·1997-07-23
K972333 — AMMONIA/IRON STANDARD KITVerichem Laboratories, Inc.·Product code JIX·1997-07-23
K972344 — MIRACLE-EAR DIGITAL BTEMiracle-Ear, Inc.·Product code ESD·1997-07-23
K972345 — DAHLBERG/MIRACLE-EARMiracle-Ear, Inc.·Product code ESD·1997-07-23
K972346 — MIRACLE-EAR ITE DIGITALMiracle-Ear, Inc.·Product code ESD·1997-07-23
K972400 — MYRINGOTOMY TUBE - BOBBIN WITH TABMednet Locator, Inc.·Product code ETD·1997-07-23
K972431 — MERIDIAN DSPMicro-Ear Technology, Inc.·Product code ESD·1997-07-23
K972542 — JAZZ PP AGC-O, JAZZ PPTrutone·Product code ESD·1997-07-23
K972543 — TWIST PPAGC-1, TWIST PPTrutone·Product code ESD·1997-07-23
K962950 — CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc.·Product code IYE·1997-07-22
K963898 — MODEL 6495 BIPOLAR TEMPORARY PACING LEADMedtronic Vascular·Product code LDF·1997-07-22
K971182 — TOX A/B TESTTechlab, Inc.·Product code LLH·1997-07-22
K971223 — CRYO CHECK FACTOR V DEFICIENT PLASMAPrecision Biologicals, Inc.·Product code GJT·1997-07-22
K971437 — BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000Murray Electronics·Product code NYN·1997-07-22
K971620 — QUANTA LITE RUBEOLA (MEASLES) IGGInova Diagnostics, Inc.·Product code LJB·1997-07-22
K971754 — LIQUID GLUCOSE (HEXOKINASE) REAGENT SETPointe Scientific, Inc.,·Product code CFR·1997-07-22
K971761 — PERSONALLAB AUTOMATED MICROPLATE ANALYZERBiochem Immunosystems (U.S.), Inc.·Product code JJE·1997-07-22
K971797 — LAPAROSCOPIC BLADDER NECK SUSPENSION KITLouisville Laboratories, Inc.·Product code HET·1997-07-22
K971801 — LAPAROTOMY BLADDER NECK SUSPENSION KITLouisville Laboratories, Inc.·Product code EZL·1997-07-22
K972011 — OPUS ETHANOLBehring Diagnostics, Inc.·Product code DIC·1997-07-22
K972041 — EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)Sigma Diagnostics, Inc.·Product code LBS·1997-07-22
K972404 — VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code KJA·1997-07-22
K960587 — CPROTECTOR 2000Certified Safety Mfg., Inc.·Product code CBP·1997-07-21
K963790 — UNI-GRAFT K DVAtrium Medical Corp.·Product code DSY·1997-07-21
K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-705Victoreen, Inc.·Product code JAD·1997-07-21
K970178 — CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEMCorpak, Inc.·Product code KNT·1997-07-21
K970573 — FLEXART V3.5 SOFTWAREToshiba America Mri, Inc.·Product code LNH·1997-07-21
K971019 — CHASE VESSEL CANNULAChase Medical, Inc.·Product code DWF·1997-07-21
K971138 — DINABASE (TM)Sultan Chemists, Inc.·Product code EBI·1997-07-21
K971608 — CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMCordis Corp.·Product code DYB·1997-07-21
K971641 — ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.·Product code EKM·1997-07-21
K971706 — TIADAPT ABUTMENT SYSTEMNobel Biocare Uas, Inc.·Product code NHA·1997-07-21
K971758 — CAUTERIZATION SMOKE EVACUATORApplied Medical Technologies·Product code GEI·1997-07-21
K972416 — MOMO DESIGN OR MOMOMomo U.S.A., Inc.·Product code HQY·1997-07-21
K972671 — BUN (LIQUID) REAGENT SETPointe Scientific, Inc.,·Product code CDQ·1997-07-20
K954320 — MODIFIED PEDIKAIRKinetic Concepts, Inc.·Product code FNM·1997-07-18
K961392 — ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT IISil-Med Corp.·Product code FJS·1997-07-18
K962159 — STERILE AMBULATORY RESERVOIR 60ML/100MLFaulding Medical Device Co.·Product code MRZ·1997-07-18
K963574 — PULSE*SPRAY INJECTORAngioDynamics, Inc.·Product code FRN·1997-07-18
K964036 — CARDIOMAGIC 2000 SOFTWAREInstromedix, Inc.·Product code DXH·1997-07-18
K970547 — ISOLYSER SDS SHARPS CONTAINERThantex Specialties, Inc.·Product code FMI·1997-07-18
K971226 — CRYO CHECK FACTOR IX DEFICIENT PLASMAPrecision Biologicals, Inc.·Product code GJT·1997-07-18
K971227 — CRYO CHECK FACTOR X DEFICIENT PLASMAPrecision Biologicals, Inc.·Product code GJT·1997-07-18
K971310 — AESCULAP JET IRRIGATION SYSTEMAesculap, Inc.·Product code GEI·1997-07-18
K971446 — 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160)3M Company·Product code GEI·1997-07-18
K971459 — DERMALASEEndo Technic Corp.·Product code GEX·1997-07-18
K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTSAllied Biomedical Corp.·Product code FWP·1997-07-18
K971479 — DURALASTIC ANATOMICAL MALAR IMPLANTSAllied Biomedical Corp.·Product code LZK·1997-07-18
K971481 — DURALASTIC ANATOMICAL NASAL IMPLANTSAllied Biomedical Corp.·Product code FZE·1997-07-18
K971568 — REST MATTRESSRest Mattress·Product code FNM·1997-07-18
K971579 — CORDIS OPTA 5 PTA BALLOON CATHETERCordis Corp.·Product code LIT·1997-07-18
K971581 — HEMISPHERE CEMENTED CUPOrtho Development Corp.·Product code JDI·1997-07-18
K971598 — STERICHEK CHLORINE REAGENT STRIPSEnvironmental Test Systems, Inc.·Product code MSY·1997-07-18
K971743 — SHARPLAN CO2 SURGICAL LASER SYSTEMSharplan Lasers, Inc.·Product code GEX·1997-07-18
K971783 — SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEMSynthes (Usa)·Product code HTY·1997-07-18
K971816 — ATLAS FRACTURE PROXIMAL HUMERAL NAILBiomet, Inc.·Product code HSB·1997-07-18
K972131 — BREATH ACE BREATHFRESHENERBeyond 21st Century, Inc.·Product code LCN·1997-07-18
K961719 — EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESHowmedica Leibinger, Inc.·Product code HRS·1997-07-17
K965123 — PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)Burke, Inc.·Product code INI·1997-07-17
K970471 — MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)Mentor Corp.·Product code LFL·1997-07-17
K971189 — P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)Johnson & Johnson Professionals, Inc.·Product code JWH·1997-07-17
K971224 — CRYO CHECK FACTOR VII DEFICIENT PLASMAPrecision Biologicals, Inc.·Product code GJT·1997-07-17
K971225 — CRYO CHECK FACTOR VIII DEFICIENT PLASMAPrecision Biologicals, Inc.·Product code GJT·1997-07-17
K971418 — CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZERChiron Diagnostics Corp.·Product code MOI·1997-07-17
K971450 — SOMNOPLASTY SYSTEMSomnus Medical Technologies, Inc.·Product code GEI·1997-07-17
K971755 — HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEMHowmedica Corp.·Product code JEC·1997-07-17
K972155 — CREATINE KINASE (CK)Stanbio Laboratory·Product code CGS·1997-07-17
K972297 — AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.·Product code JFJ·1997-07-17
K964439 — NEEDLE-FREE VALVED CONNECTOR AND CAPBmw Medical, Inc.·Product code FPA·1997-07-16
K964821 — COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67Ventrex, Inc.·Product code DQA·1997-07-16
K965172 — OXIMETER PRE-AMP CABLEEpic Medical Equipment Services, Inc.·Product code DQA·1997-07-16
K970478 — SCT 3000 HEATED HUMIDIFIERMarquest Medical Products, Inc.·Product code BTT·1997-07-16
K971414 — ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSSmith & Nephew, Inc., Orthopaedic Div.·Product code LZO·1997-07-16
K971416 — OLYMPUS OES OTV-S5C VIDEO SYSTEMOlympus America, Inc.·Product code FET·1997-07-16
K971457 — BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIEDArcan Orthopaedic Corp.·Product code KWP·1997-07-16
K971461 — SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)Fisher & Paykel Electronics , Ltd.·Product code FMT·1997-07-16

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