FDA 510(k) clearances — page 978

176,637 clearances on record, most recent first.

Clearances — page 978

97,701–97,800 of 176,637

K961930 — CHONDROPROTECThe Hymed Group Corp.·Product code MGQ·1996-10-15
K962415 — HEMOCUE B-GLCOSE SYSTEMHemocue, Inc.·Product code LFR·1996-10-15
K962684 — S-357 VIDEO IMAGING SYSTEMDel Medical Systems Corp.·Product code GCJ·1996-10-15
K962744 — HAEMOPHILUS TEST MEDIUM AGAR (HTM)Prepared Media Laboratory, Inc.·Product code JSO·1996-10-15
K962797 — ECAT EXACT & ECAT EXACT HR+Cti Pet Systems, Inc.·Product code KPS·1996-10-15
K962805 — SPYGLASS ANGIOGRAPHIC CATHETERDaig Corp.·Product code DQO·1996-10-15
K963012 — BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)Bioject, Inc.·Product code LHI·1996-10-15
K963251 — CIBA CORNING ACS; 180 DPD ASSAYCiba Corning Diagnostics Corp.·Product code JMM·1996-10-15
K963266 — NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLAREDIntermedics Orthopedics·Product code LPH·1996-10-15
K963459 — SUPPORT VESTSkil-Care Corp.·Product code KID·1996-10-15
K953213 — COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)Wembley Rubber Products (M) Sdn Bhd·Product code LYY·1996-10-11
K954416 — POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVESHartalega Sdn Bhd·Product code LYY·1996-10-11
K955712 — USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATINGC.R. Bard, Inc.·Product code LDF·1996-10-11
K961166 — FLOWTRON EXCEL PUMPHne Healthcare, Inc.·Product code JOW·1996-10-11
K961368 — TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KITVasamedics, LLC·Product code DPT·1996-10-11
K961423 — OSOM STREP A TESTWyntek Diagnostics, Inc.·Product code GTZ·1996-10-11
K962078 — TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETERContinental Medical Laboratories, Inc.·Product code JOH·1996-10-11
K962149 — SAFETY CRADLESpecialized Health Products, Inc.·Product code FMI·1996-10-11
K962394 — IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPSImplant Integration Systems, Inc.·Product code DZE·1996-10-11
K962733 — CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)Union Broach, Div. Moyco Industries, Inc.·Product code EMA·1996-10-11
K962746 — CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KITCordis Corp.·Product code DYB·1996-10-11
K962761 — REIGEL TUNNELING DEVICECook, Inc.·Product code GYK·1996-10-11
K962799 — MINIATURE LAPAROSCOPE SET (MINI LAP)Richard Wolf GmbH·Product code GCJ·1996-10-11
K962905 — TX BIOPSY NEEDLEGallini S.R.L.·Product code FCG·1996-10-11
K962972 — SURGICADE GAUZE SPONGEAccunex Canada,Inc.·Product code EFQ·1996-10-11
K963032 — FREE CHOICEFirst Quality Hygienic, Inc.·Product code HEB·1996-10-11
K963050 — TRADITION P, PUSH BUTTON HANDPIECEMidwest Dental Products Corp.·Product code EFB·1996-10-11
K963141 — KUGEL HERNIA PATCHDouglas Bueschel·Product code FTL·1996-10-11
K963294 — HEELBO WRAP AROUND VESTHeelbo, Inc.·Product code FMQ·1996-10-11
K963332 — THERMO-PLASTIC SHAVER BLADESStryker Endoscopy·Product code HRX·1996-10-11
K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.·Product code KMK·1996-10-11
K963461 — SAFETY PONCHO/SHOULDER STRAP PONCHOSkil-Care Corp.·Product code KID·1996-10-11
K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.·Product code JFL·1996-10-11
K963652 — PULPDENT DESENSITIZERPulpdent Corp.·Product code EBF·1996-10-11
K963685 — EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLERNorth Eos Industries, Inc.·Product code HHT·1996-10-11
K954481 — P.F.C. UNI-COMPARTMENTAL KNEE SYSTEMJohnson & Johnson Professionals, Inc.·Product code HRY·1996-10-10
K955137 — IM C-MENT ACETABULAR CAPImplant Ideas, LLC·Product code JDI·1996-10-10
K960515 — PARAPACPneupac , Ltd.·Product code BTL·1996-10-10
K960710 — CONDOMPolar Latex , Ltd.·Product code HIS·1996-10-10
K961165 — HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600AHewlett-Packard Co.·Product code DSI·1996-10-10
K961228 — KARL STORZ MAGNIFYING ARTHROSOCPESKARL STORZ Endoscopy-America, Inc.·Product code HRX·1996-10-10
K961889 — SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMSDiagnostic Products Corp.·Product code DHB·1996-10-10
K961929 — FACTOR DEFICIENT PLASMAUniversal Reagents, Inc.·Product code GGP·1996-10-10
K962127 — OHMEDA 3800 PULSE OXIMETEROhmeda Medical·Product code DQA·1996-10-10
K962738 — MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSGE Medical Systems·Product code KPS·1996-10-10
K962749 — THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORTDiemolding Corp.·Product code BWF·1996-10-10
K962759 — 4F NYLEX ANGIOGRAPHIC CATHETERCordis Corp.·Product code DQO·1996-10-10
K962766 — AIRSEP IMPULSEAirsep Corp.·Product code NFB·1996-10-10
K962926 — ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYAmerican Laboratory Products Co., Ltd.·Product code MID·1996-10-10
K962953 — DEODORANT PANTY SHIELDParagon Trade Brands, Inc.·Product code HHL·1996-10-10
K962954 — DEODORANT MAXI PADParagon Trade Brands, Inc.·Product code HHL·1996-10-10
K962962 — DEODORANT PANTY LINERParagon Trade Brands, Inc.·Product code HHL·1996-10-10
K963056 — ED-3410, VIDEO DUODENOSCOPEPentax Precision Instrument Corp.·Product code FDT·1996-10-10
K963118 — EXTREMITY BONE SCREWAcu Med, Inc.·Product code HWC·1996-10-10
K963180 — VIDAMED RF GENERATOR DATA RECORDERVidamed, Inc.·Product code GEI·1996-10-10
K963220 — TEMPRA COLD PACK, REORDER NO. TC150Tempo Technology, Inc.·Product code IMD·1996-10-10
K963390 — BIOPSY INTRODUCER NEEDLEBaxter Healthcare Corp·Product code KNW·1996-10-10
K963398 — ALTA FULLY THREADED CROSS-LOCKING SCREWSHowmedica Corp.·Product code HWC·1996-10-10
K963536 — SIGMA DIAGNOSTICS CALICIUM REAGENTSigma Diagnostics, Inc.·Product code CJY·1996-10-10
K963752 — PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESISGrace Medical, Inc.·Product code ETB·1996-10-10
K961841 — BARD V-MAX ROLLER BAR (3551XX; XX=01,02,03,04,05, OR 06)C.R. Bard, Inc.·Product code FAS·1996-10-09
K962006 — MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.·Product code HQD·1996-10-09
K962707 — MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SETMinntech Corp.·Product code KDI·1996-10-09
K962778 — THE L-BOW ARM RESTRAINTHeelbo, Inc.·Product code FMQ·1996-10-09
K962810 — GREAT HANDS MITTSHeelbo, Inc.·Product code FMQ·1996-10-09
K962886 — ANESTHESIA CONDUCTION NEEDLEIspg, Inc.·Product code BSP·1996-10-09
K962921 — BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETERC.R. Bard, Inc.·Product code EZN·1996-10-09
K963084 — OPUS CMV TEST SYSTEM-MODIFICATIONBehring Diagnostics, Inc.·Product code LFZ·1996-10-09
K963108 — HEELBO QUILTED TORSO RESTRAINTHollister, Inc.·Product code FMQ·1996-10-09
K963237 — HEELBO ICU 911 BLAZER SLEEVED JACKETHeelbo, Inc.·Product code FMQ·1996-10-09
K963457 — SLEEPER JACKET/HOUDINI SAFETY SLEEPERSkil-Care Corp.·Product code FMQ·1996-10-09
K963460 — ROLL BELTSkil-Care Corp.·Product code FMQ·1996-10-09
K946127 — OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEMOhmeda Medical·Product code BSZ·1996-10-08
K954584 — RACZ EPIDURAL CATHETERMedic Evaluation Devices & Instruments Corp.·Product code BSO·1996-10-08
K954658 — PERNECZKY CLIP APPLIER/REMOVERVon Zeppelin GmbH·Product code HCI·1996-10-08
K955520 — RESCUE BREATHERInternational Safety, Inc.·Product code CBP·1996-10-08
K955715 — CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)Abbott Laboratories·Product code GKZ·1996-10-08
K955877 — ZIMMER ZIRCONIA CERAMIC FEMORAL HEADZimmer, Inc.·Product code LZO·1996-10-08
K955891 — CARDIOVIEW TRANSTELEPHONIC SOFTWAREMicromedical, Inc.·Product code DPS·1996-10-08
K960918 — VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEMVidamed, Inc.·Product code GEI·1996-10-08
K960991 — ETEST SUBMISSION FOR AMOXICILLINAb Biodisk·Product code JWY·1996-10-08
K961378 — DELTA HIP PROSTHESISZimmer, Inc.·Product code LWJ·1996-10-08
K961401 — HP CATHSTATION - MODEL M1264BHewlett-Packard Co.·Product code DPS·1996-10-08
K961463 — HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2Heartport, Inc.·Product code GCJ·1996-10-08
K961590 — APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SETLinvatec Corp.·Product code HRX·1996-10-08
K961647 — DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCILDeroyal Industries, Inc.·Product code GEI·1996-10-08
K961769 — AIR-MEDEX IRobert Gold Assoc.·Product code FNM·1996-10-08
K962042 — GLASS SYRINGEIspg, Inc.·Product code FMF·1996-10-08
K962098 — ESOPHAGEAL INTUBATION DETECTORKirk Specialty Systems·Product code BTR·1996-10-08
K962464 — SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)Scantibodies Laboratory, Inc.·Product code JLW·1996-10-08
K962497 — Q-TIPS, FAICHNEY, PRIVATE LABELFaichney Medical Co.·Product code FLL·1996-10-08
K962803 — APEX FINDER MODELS 7005Sybron Dental Specialties, Inc.·Product code LQY·1996-10-08
K962941 — OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZEDeep Trading Corp.·Product code LCN·1996-10-08
K962966 — IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.·Product code JTO·1996-10-08
K963123 — ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)Arthrocare Corp.·Product code GEI·1996-10-08
K963253 — SYNTHETIC ABSORBABLE SURGICAL SUTUREUnited States Surgical, A Division of Tyco Healthc·Product code GAM·1996-10-08
K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROLSkil-Care Corp.·Product code KID·1996-10-08
K963456 — LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDERSkil-Care Corp.·Product code FMQ·1996-10-08
K963499 — MIRROR FINISH BIPOLAR FORCEPSJohnson & Johnson Professionals, Inc.·Product code GEI·1996-10-08
K963644 — A-1000 EEG MONITOR AND A-1050 EEG MONITORAspect Medical Systems, Inc.·Product code OLW·1996-10-08

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