Atlas FDA

2002

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

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RecordFirmDate
CARDIOVENTION CORX SYSTEM, MODEL FG 0001 (K012325)Cardiovention, Inc.2002-04-09
STRATASIS SLING KIT (K020654)Cook Biotech, Inc.2002-04-09
ATHOS LASER (K020072)Quantel Medical2002-04-09
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE (K020376)Advanced Healthcare , Ltd.2002-04-09
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN (K020139)Ciba Vision Corporation2002-04-09
MODEL GT010706 ELECTRONIC THERMOMETER (K021052)Global Treasure Industries , Ltd.2002-04-09
FRIALOC DENTAL IMPLANT SYSTEM (K013067)Friadent GmbH2002-04-09
CHEMISTRY CALIBRATOR (K020454)Jas Diagnostics, Inc.2002-04-08
SURGIC IV IMPLANT CONTROL UNIT (K020327)Nakanishi, Inc.2002-04-08
MODEL GT980201 ELECTRONIC THERMOMETER (K021028)Global Treasure , Ltd.2002-04-08
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 (K013848)U-Systems, Inc.2002-04-08
AL-2000 COMBINED BIOMETER AND PACHYMETER (K012803)Tomey Corp.2002-04-08
BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM (K013672)Azary Technologies, LLC2002-04-08
HDR MIAMI APPLICATOR (K020176)Mick Radio-Nuclear Instruments, Inc.2002-04-08
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 (K012417)Hygia Health Services, Inc.2002-04-08
MONITORING SYSTEM,MODEL ARGUS PB-1000 (K012226)Schiller AG2002-04-08
ENVISION ANTERIOR CERVICAL PLATE SYSTEM (K020649)Ortho Development Corp.2002-04-05
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (K020548)Monobind2002-04-05
NETLINK/NETSCAN (K020213)Rozinn Electronics, Inc.2002-04-05
VIRIDIS DERMA LASER (K020071)Quantel Medical2002-04-05
HL168F (K020766)Health & Life Co., Ltd.2002-04-05
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 (K020765)Boston Scientific Corp2002-04-05
KING OF HEARTS EXPRESS + AF MONITOR (K020825)Card Guard Scientific Survival , Ltd.2002-04-05
RUBICOR BREAST BIOPSY DEVICE (K020047)Rubicor Medical, Inc.2002-04-05
HISONIC-TRD TINNITUS RELIEF DEVICE (K013253)Hearing Innovations, Inc.2002-04-05
MIETHKE SHUNT SYSTEM (K020728)Aesculap, Inc.2002-04-05
SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 (K020252)Harvest Technologies, Corp.2002-04-05
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (K013988)Millipore Corp.2002-04-04
VT-1 (K020154)Pos-T-Vac, Inc.2002-04-04
CAL-CHEX CD PLUS (K020469)Streck Laboratories, Inc.2002-04-04
BIOSUC (K013108)Hakko Medical Co., Ltd.2002-04-04
PAIN CARE 4200 (K020988)Breg, Inc.2002-04-04
GARAVENTA SUPER-TRAC TRE-52 (K020933)Garaventa Accessibility2002-04-04
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) (K020970)Biomet, Inc.2002-04-04
RESECTION ABLATOR (K013369)Linvatec Corp.2002-04-04
ORTHOPILOT 2 (K013569)Aesculap, Inc.2002-04-04
MEDICAL LE (K020058)Barco N.V.2002-04-04
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X (K020998)Terumo Cardiovascular Systems Corp.2002-04-04
APOLLO, MODEL 1124525 (K020949)Sterngold2002-04-04
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K020997)Dideco S.P.A.2002-04-04
TRUWAVE (K013210)Dan Med, Inc.2002-04-04
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K020323)Becton, Dickinson & CO2002-04-04
GYRUS ENT SOMNOPLASTY GENERATOR (K020067)Gyrus Ent LLC2002-04-04
LONG LENGTH GAMMA NAIL (K020773)Howmedica Osteonics Corp.2002-04-04
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM (K013428)Ohio Medical Instrument Co., Inc.2002-04-04
SUPPORT SLEEVE (K020258)Pos-T-Vac, Inc.2002-04-04
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS (K013088)Echotech 3D Imaging Systems, Inc.2002-04-04
GE VIVID 3 EXPERT; GE VIVID 3 PRO (K020789)General Electric Co.2002-04-04
ADPER PROMPT (K020946)3M Espe AG Dental Products2002-04-04
2 PIECE MODULAR HIP STEM (K013106)Howmedica Osteonics Corp.2002-04-03
RIGID GAS PERMEABLE CONTACT LENS (K013762)Bausch & Lomb, Incorporated2002-04-03
CT-C3000 SPIRAL CT SCANNER SYSTEM (K020913)Neusoft Digital Medical Systems Co., Ltd.2002-04-03
EBI OMEGA21 SPINAL FIXATION SYSTEM (K020681)Ebi, L.P.2002-04-03
CARIS MINITOME BIOPSY INSTRUMENT (K020024)Artemis Medical, Inc.2002-04-03
SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (K012221)Biosafe Laboratories, Inc.2002-04-03
ADVANTA SST BIFURCATED GRAFT (K020767)Atrium Medical Corp.2002-04-03
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (K020592)Alba-Waldensian, Inc.2002-04-03
TISSUEMEND SOFT TISSUE REPAIR MATRIX (K020455)Tei Biosciences, Inc.2002-04-03
POWER TEK II (K020761)Biomet, Inc.2002-04-03
REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE (K020308)Ssl America'S, Inc.2002-04-03
AQUIFY LENS COMFORT DROPS (K013204)Ciba Vision Corporation2002-04-03
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 (K020929)GE Medical Systems2002-04-03
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP (K020147)Medtronic Perfusion Systems2002-04-03
IMAGEDESK (K020061)Barco N.V.2002-04-03
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR (K020688)Hydrocision, Inc.2002-04-03
SAFE-STEER GUIDE WIRE SYSTEM (K011986)Intra Luminal Therapeutics, Inc.2002-04-03
MFCD 118I (K020059)Barco N.V.2002-04-03
UPLINK TEST SYSTEM (K020371)OraSure Technologies, Inc.2002-04-03
MODIFICATION TO TRELEX MESH SURGICAL MESH (K020110)Boston Scientific2002-04-03
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW (K020674)Blackstone Medical, Inc.2002-04-03
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (K020935)Hemocue, Inc.2002-04-03
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K020769)Lin-Zhi International, Inc.2002-04-03
OXOID PBP2 1 LATEX AGGLUTINATION TEST (K011710)Oxoid , Ltd.2002-04-02
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM (K020682)C.R. Bard, Inc.2002-04-02
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET (K020221)Biomet Orthopedics, Inc.2002-04-02
CROSSPOINT TRANSACCESS CATHETER (K013363)Trans Vascular Incorporated2002-04-02
MULTI HI-FLO PNEU, WISAP #7080 (K011510)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2002-04-02
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B (K020043)Arthrex, Inc.2002-04-02
IMMUNE CELL FUNCTION ASSAY (K013169)Cylex, Inc.2002-04-02
SIMPLICITY SIMPLEX SOFT INFUSION SET (K020629)Sterling Medivations, Inc.2002-04-01
RE-USABLE STERILIZATION POUCH / BAG (K013715)Quality Products of Montana2002-04-01
DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (K020659)Ssl Americas, Inc.2002-03-29
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM (K020650)Howmedica Osteonics Corp.2002-03-29
GAMMA 3 LAG SCREW (K020677)Howmedica Osteonics Corp.2002-03-29
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM (K014302)Pisharodi Surgicals, Inc.2002-03-29
RESORBABLE LACTOSORB-L ACL CROSSPIN (K014305)Arthrotek, Inc.2002-03-29
LIFEGUARD SAFETY INFUSION SET (K013871)Horizon Medical Products, Inc.2002-03-29
D.SIGN 15 (DW286 B) (K020898)Ivoclar Vivadent, Inc.2002-03-29
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN (K020871)bioMerieux, Inc.2002-03-29
DYNA INTRA-LIMBAL LENS (K020006)Lens Dynamics, Inc.2002-03-29
O'REGAN DISPOSABLE ANOSCOPE (K020702)Canadian Theatre Products , Ltd.2002-03-29
OPTILUX CURING LIGHTS (K020267)Sybron Dental Specialties, Inc.2002-03-29
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F (K013779)Mesure Technology2002-03-29
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (K020467)Helena Laboratories2002-03-29
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO (K020973)Surgilight, Inc.2002-03-29
ENTEC PLASMA WANDS (K014290)Arthrocare Corp.2002-03-28
HEMOCHRON JR. SIGNATURE + (K020798)International Technidyne Corp.2002-03-28
SURETONE (K011588)Suretone International2002-03-28
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB (K020669)Oscor, Inc.2002-03-28
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY (K020441)Dade Behring, Inc.2002-03-28
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Every clearance here is in the API, with alerts when new ones post.