Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M (K020130)Rolor Electronics Corp.2002-12-02
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT (K022933)Evenflo Company, Inc.2002-12-02
HOME CARE JELLY (K022494)Roc Chinese-European Industrial Research Society2002-12-02
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT (K021501)Kinetic Concepts, Inc.2002-12-02
HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS (K022993)Hoveround Corp.2002-12-02
CYNOVAD ZIRKON (K023327)Cynovad2002-12-02
SCOOTER MARS SERIES, MODEL TL-588 (K022698)Teh Lin Prosthetic & Orthopaedic, Inc.2002-12-02
SANIDAD TENS-DUO MODE GP8016N (K021430)Rolor Electronics Corp.2002-12-02
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE (K020837)Shanghai Motex Healthcare Co., Ltd.2002-12-02
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE (K023517)Wrp Asia Pacific Sdn. Bhd.2002-12-02
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) (K023514)Bacchus Vascular, Inc.2002-12-02
MODULAR HEAD BONE SCREW (K022952)Biomet, Inc.2002-12-02
EXEL VACULET BLOOD COLLECTION SET (K020533)Exelint Intl. Co.2002-12-02
COLLATEK HYDROGEL (K022995)Biocore Medical Technologies, Inc.2002-12-02
COMFORT AGILE SCOOTER, LY-EW303 (K023581)Comfort Orthopedic Co., Ltd.2002-12-02
EXPLORER POWERED WHEELCHAIR (K023485)Evermed Corp.2002-12-02
SST SALIVA SUPPORTING TABLETS (K023046)Sinclair Pharmaceuticals, Ltd.2002-12-02
EVLT KIT AND D15PLUS AND D30PLUS DIODE (K023543)Diomed, Inc.2002-12-02
EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES (K023523)Ever-More Latex Products Sdn Bhd2002-11-29
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) (K023765)Stellartech Research Corp.2002-11-29
PHILIPS DRUG CALCULATOR SOFTWARE (K023674)Philips Medical Systems2002-11-29
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR (K023522)Ever-More Latex Products Sdn Bhd2002-11-29
NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 (K023812)Erbe USA, Inc.2002-11-29
ELECSYS PROBNP CALCHECK (K020883)Roche Diagnostics Corp.2002-11-29
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES (K023524)Ever-More Latex Products Sdn Bhd2002-11-29
UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES (K023767)The Olympus Optical Co.2002-11-29
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST (K022915)Alfa Scientific Designs, Inc.2002-11-29
MODIFICATION TO RADIAL HEAD IMPLANT (K023604)Avanta Orthopaedics, Inc.2002-11-27
CHILLBUSTER (K022903)Microtek Medical, Inc.2002-11-27
ADAPTERS WITH X-COATING (K022918)Terumo Cardiovascular Systems Corporation2002-11-27
MIRAGE FULL FACE MASK SERIES 2 (K023284)Resmed, Ltd.2002-11-27
RECOVERY FILTER SYSTEM, MODEL RF-048F (K022236)C.R. Bard, Inc.2002-11-27
DATEX-OHMEDA HMEF MINI (K023641)Datex-Ohmeda2002-11-27
MIRAGE FULL FACE MASK SERIES 2 (K023306)Resmed, Ltd.2002-11-27
CADENCE PEEK CEMEENT RESTRICTOR (K023647)Spinal Concepts, Inc.2002-11-27
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST (K023699)Unipath , Ltd.2002-11-27
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C (K022977)Dade Behring, Inc.2002-11-27
MIRAGE FULL FACE MASK SERIES 2 (K023244)Resmed, Ltd.2002-11-27
ENDOVASCULAR GUIDE WIRE (K021363)Stereotaxis, Inc.2002-11-27
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022329)Bayer Diagnostics Corp.2002-11-27
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES (K023479)First Quality Hygienic, Inc.2002-11-26
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) (K023530)Westcon Contact Lens Co., Inc.2002-11-26
CIRCUIT TUBINGS WITH X-COATING (K023056)Terumo Cardiovascular Systems Corp.2002-11-26
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) (K023033)<Genx> Intl., Inc.2002-11-26
SYNTHES CERVIFIX/ AXON (K023675)Synthes (Usa)2002-11-26
INNOVA 4100 (K023178)Ge Medical Systems, Inc.2002-11-26
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022887)Osteomed Corp.2002-11-26
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) (K013072)Synthes2002-11-26
RANDOX HAEMOGLOBIN A1C (K021897)Randox Laboratories, Ltd.2002-11-26
MY BREAST FRIEND, BREAST SELF-EXAM PAD (K023390)Mbf Sales, LLC2002-11-26
SAFETOUCH (K022861)Rusin Medical Devices2002-11-26
RENEGADE STC 18 MICROCATHETER (K023681)Boston Scientific Corp2002-11-26
CANON FULL AUTO TONOMETER TX-F (K023816)Canon, Inc.-Utsunomiya Optical Products Operation2002-11-26
ALOCLAIR ORAL RINSE (K023155)Sinclair Pharmaceuticals, Ltd.2002-11-25
RADLITE TISSUE RETRACTOR SYSTEM (K022989)Genzyme Biosurgery2002-11-25
ENDOTACK (K022853)KARL STORZ Endoscopy-America, Inc.2002-11-25
ACCESS HYPERSENSITIVE HTSH ASSAY (K023093)Beckman Coulter, Inc.2002-11-25
COBAS INTEGRA ONLINE DAT II COCAINE II (K023296)Roche Diagnostics Corp.2002-11-25
DEMETECH SILK NONABSORBABLE SUTURE (K023029)Demetech Corp.2002-11-25
ASCENSION SILLICONE MCP (K022892)Ascension Orthopedics, Inc.2002-11-25
BD VACUTAINER SST II PLUS TUBES (K023331)Becton, Dickinson & CO2002-11-25
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE (K022686)Lap Surgical Systems, LLC2002-11-25
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM (K022800)Hyperion, Inc.2002-11-25
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) (K023066)Sodemsystems2002-11-25
ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 (K023768)Cti Pet Systems, Inc.2002-11-25
MICROHYBRID 11 (K022971)Ab Ardent2002-11-25
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM (K022838)Fotona D.D.2002-11-25
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM (K022839)Fotona D.D.2002-11-25
FOTONA TANDEM LASER SYSTEM (K022837)Fotona D.D.2002-11-25
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE (K023075)Bd Vacutainer Systems Preanalyical Solutions2002-11-25
AQUEOUS ACRYLIC DISPERSION 28% W/W (K023671)Chx Technologies, Inc.2002-11-25
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM (K023644)Spinal Concepts, Inc.2002-11-25
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022886)Osteomed Corp.2002-11-25
SOMATOM EMOTION 6 CT SYSTEMS (K023687)Siemens Medical Systems, Inc.2002-11-22
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 (K022899)Philips Medical Systems North America Co.2002-11-22
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G (K023750)Canon USA, Inc.2002-11-22
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B (K023760)Toshiba America Medical Systems, In.C2002-11-22
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 (K022970)Amicas, Inc.2002-11-22
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II (K022817)Icn Pharmaceuticals, Inc.2002-11-22
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K023772)Acuson Corp.2002-11-22
INSPIRATION VENTILATOR SYSTEM (K021112)eVent Medical, Ltd.2002-11-22
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION (K021397)Biosphere Medical, Inc.2002-11-22
STAT PROFILE CRITICAL CARE XPRESS ANALYZER (K022746)Nova Biomedical Corp.2002-11-22
MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K023665)Bioplate, Inc.2002-11-22
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K023555)Medtronic Sofamor Danek, Inc.2002-11-22
KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX (K022057)Kyung GI Medical Ind. Co., Ltd.2002-11-22
BLOCKING TRAY (K023636)Southeastern Radiation Products, Inc.2002-11-22
MICROHYBRID 12 (K022974)Ab Ardent2002-11-22
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR (K022827)Linvatec Corp.2002-11-22
ETCHING 15 (K022975)Ab Ardent2002-11-22
804SIII; 804W; LIBRA TENS; 410; S-TENS II (K021846)Body Clock Health Care, Ltd.2002-11-22
ADHESIVE 14 (K022973)Ab Ardent2002-11-22
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 (K023252)Icn Biomedicals, Inc.2002-11-22
MICROFILL 13 (K022972)Ab Ardent2002-11-22
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 (K023352)Maine Standards Co.2002-11-22
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 (K023110)Digirad Corp.2002-11-22
TRX VERTICAL POSITIONER (K023426)Motion Concepts2002-11-21
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 (K023622)Stockert Instrumente GmbH2002-11-21
ALPHATRAC, MODEL A 205 (K022652)Teftec Corp.2002-11-21
WIZAIR COMPRESSION SYSTEM (K023573)Medical Compression Systems (Dbn) , Ltd.2002-11-21
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Every clearance here is in the API, with alerts when new ones post.