Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 (K022364)Orthosoft, Inc.2003-02-04
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (K023715)Starmatrix Sdn Bhd2003-02-04
CONTREET FOAM ADHESIVE/NON-ADHESIVE (K022416)Coloplast Corp.2003-02-03
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE (K024355)Yty Industry (Manjung) Sdn Bhd2003-02-03
REPROCESSED EXTERNAL FIXATION DEVICE (K023714)Alliance Medical Corp.2003-02-03
POWDERED VINYL EXAMINATION GLOVES (K024016)Top Glove (Zhangjiagang) Co. , Ltd.2003-02-03
WATERLASE FOR APICOECTOMY (K022803)Biolase Technology, Inc.2003-02-03
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES (K020318)Scivolutions, Inc.2003-02-03
ARTHROCARE ENT COBLATOR SURGERY SYSTEM (K030108)Arthrocare Corp.2003-02-03
RADIUS MICRO SNARE (K022201)Radius Medical Technologies, Inc.2003-02-03
SIASCOPE II (K023729)Astron Clinica Limited2003-02-03
THERMACOOL TC SYSTEM (K030142)Thermage, Inc.2003-02-03
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (K022483)Johnson & Johnson Medical, Ltd.2003-02-03
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT (K023724)Howmedica Osteonics Corp.2003-02-03
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 (K024118)Micro Therapeutics, Inc.2003-02-03
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 (K023725)Marina Medical Instruments, Inc.2003-02-03
BREASTVIEW VISUAL MAPPING SYSTEM (DEN020001)Assurance Medical2003-01-31
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML (K024152)Becton, Dickinson & CO2003-01-31
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES (K023984)The Olympus Optical Co.2003-01-31
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S (K023792)Thermo Orion2003-01-31
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (K023712)Advantage Diagnostics Corp.2003-01-31
SETPOINT CHEMISTRY CALIBRATOR (K030169)Bayer Healthcare, LLC2003-01-31
MODIFICATION TO PENTRA 60 AND PENTRA 60C+ (K030144)Abx Diagnostics2003-01-31
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (K024053)Oscor, Inc.2003-01-31
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM (K023561)International Technidyne Corp.2003-01-31
RADIOMED MARKER (K022326)Radiomed Corporation2003-01-31
RTDOSEPLAN (K022961)Math Resolutions, LLC2003-01-31
AHL GENERIC GLASS IONOMER LUTING CEMENT (K023981)Advanced Healthcare , Ltd.2003-01-31
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) (K022596)Clover Hi-Tech, Inc.2003-01-31
ANGIONEW-IV (K023701)Living Data Technologies Corporation2003-01-30
GRADIA DIRECT (K023814)GC America, Inc.2003-01-30
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE (K021340)External Counterpulsation Lab2003-01-30
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS (K022221)Deltec, Inc.2003-01-30
BI-OSTETIC (K023703)Berkeley Advanced Biomaterials, Inc.2003-01-30
ACROSEAL ROOT CANAL OR APICAL SEALER (K023976)Septodont S.A.S.2003-01-30
KSEA SCB ACC CONTROL (K023704)KARL STORZ Endoscopy-America, Inc.2003-01-30
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER (K023688)LeMaitre Vascular, Inc.2003-01-30
BAYER ADVIA CENTAUR HER-2/NEU ASSAY (K024017)Bayer Corp.2003-01-30
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (K023677)Osmetech2003-01-29
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM (K030191)Teratech Corp.2003-01-29
CARDIMA ABLATION SYSTEM (K022008)Cardima, Inc.2003-01-29
SAS RSV TEST (K022845)Sa Scientific, Inc.2003-01-29
DEVEX MESH SYSTEM (K023835)Depuyacromed2003-01-29
AURORA MR-GUIDED INTERVENTIONAL SYSTEM (K023686)Aurora Imaging Technology, Inc.2003-01-29
APEX 90 (K030206)We Dong Myung Dental Industrial Co., Ltd.2003-01-29
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 (K030049)Rubicor Medical, Inc.2003-01-29
BICON TRANSITIONAL IMPLANT (BTI) SYSTEM (K023705)Bicon, Inc.2003-01-29
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA (K022807)Creative Technologies, Inc.2003-01-29
1-CCD ENDOCAM 5520 SYSTEM (K023659)Richard Wolf Medical Instruments Corp.2003-01-29
TRILUMINA THERAPEUTIC LASER SYSTEM (K023935)Texas Applied Biomedical Services2003-01-28
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES (K024174)General Gloves Corp.2003-01-28
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764)Beckman Coulter, Inc.2003-01-28
BIOSORB RESORBABLE VOID FILLER (K021963)Sciences ET Bio Materiaux (Sbm)2003-01-28
MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 (K024373)Elltec Co., Ltd.2003-01-28
ALUMINA V40 FEMORAL HEADS (K023901)Howmedica Osteonics Corp.2003-01-28
LFRE INDIRECT LARYNGOSCOPE (K023004)Astralite Corp.2003-01-28
GAS SAMPLING LINES (K023579)Promedic, Inc.2003-01-28
SW-180 SHORTWAVE THERAPY UNIT (K022846)Ito Co., Ltd.2003-01-28
SODEM HIGH SPEED SYSTEM (PNEUMATIC) (K023070)Sodemsystems2003-01-28
MONARCH SPINE SYSTEM (K024348)Depuyacromed2003-01-28
SOFT TISSUE ANCHORING WASHERS (K030031)Accu-Speed, Incorporated2003-01-28
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K024081)Safehealth Medical Supply Corp.2003-01-28
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS (K030150)Cliniqa Corporation2003-01-28
PRECIMED HIP SCREW SYSTEM (K023851)Precimed, Inc.2003-01-28
VAXCEL WITH PASV PORT (K030083)Boston Scientific Corp2003-01-28
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM (K023802)Synthes (Usa)2003-01-28
PALOMAR Q-YAG ND:YAG LASER SYSTEM (K023967)Palomar Medical Technologies, Inc.2003-01-27
TERABYTE 2000 HAIR REMOVER (K022341)Terabyte Co.2003-01-27
ACIST GENTOO CONTRAST INJECTION SYSTEM (K020892)Acist Medical Systems2003-01-27
SPEEDICATH (K023254)Coloplast Corp.2003-01-27
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 (K023624)Surgical Laser Technologies, Inc.2003-01-27
VACUETTE TRACE ELEMENTS TUBES (K023971)Greiner Bio-One Vacuette North America2003-01-27
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG (K022951)Candela Corp.2003-01-27
PHOENIX UNIVERSAL SHUNT SYSTEM (K024101)Phoenix Biomedical Corp.2003-01-27
ACCURA ELITE SHUNT SYSTEM (K024040)Phoenix Biomedical Corp.2003-01-27
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. (K030002)Abbott Laboratories2003-01-27
LID CHAIN EYELID WEIGHTS (K021750)Jedmed Instrument Co.2003-01-27
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 (K022929)Cardiac Science, Inc.2003-01-27
ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. (K022360)Biotronik, Inc.2003-01-27
CELSIUS CONTROL SYSTEM (K022366)Innercool Therapies2003-01-27
NITRILE EXAMINATION GLOVES, POWDER FREE (K023978)Starmatrix Sdn Bhd2003-01-24
PICCOLO TRIGLYCERIDES TEST SYSTEM (K023639)Abaxis, Inc.2003-01-24
EPW POWERED WHEELCHAIR, GP-201 (K023148)Emg Technology Co., Ltd.2003-01-24
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT (K021547)Jotec GmbH2003-01-24
PEGASUS NASAL CPAP SYSTEM (K022192)Sensor Medics Corp.2003-01-24
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K023568)Becton, Dickinson & CO2003-01-24
WU'S 3-WHEELED NEO SCOOTER, WT-T3B (K023168)Wu'S Tech Co., Ltd.2003-01-24
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (K022445)Olympus Optical Co., Ltd.2003-01-24
NITRILE EXAMINATION GLOVES, PRE-POWDERED (K023979)Starmatrix Sdn Bhd2003-01-24
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES (K023866)Kl-Kepong Rubber Products Sdn. Bhd.2003-01-24
TEH LIN JUPITER POWER CHAIR, MODEL TL-320 (K022697)Teh Lin Prosthetic & Orthopaedic, Inc.2003-01-24
SHARP VIEW IMAGE ENHANCEMENT SYSTEM (K024028)Context Vision AB2003-01-24
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS (K023970)Medis Medical Imaging Systems BV2003-01-24
MUCOGRAFT (K012423)Ed. Geistlich Soehne AG Fuer Chemische Industrie2003-01-24
NEOGENESYS 2K (K022433)Sanexas Intl. GmbH2003-01-24
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 (K022052)Northgate Technologies, Inc.2003-01-24
WU'S 3-WHEELED NEO SCOOTER, WT-L3 (K023040)Wu'S Tech Co., Ltd.2003-01-24
GOOD LUBRICATIONS (K020586)Biofilm, Inc.2003-01-24
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (K030102)Bayer Healthcare, LLC2003-01-24
PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (K023977)Starmatrix Sdn Bhd2003-01-24
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