Atlas FDA

2003

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

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RecordFirmDate
TMC ELECTRICAL SCOOTER, EASY 411 (K031314)Tmc Technology Corp.2003-09-04
TMC ELECTRICAL SCOOTER, EASY 405 (K031313)Tmc Technology Corp.2003-09-04
PIT & FISSURE SEALANT WITH FLUORIDE (K031811)Harry J. Bosworth Co.2003-09-04
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) (K032037)Medtronic Sofamor Danek2003-09-04
TMC ELECTRICAL SCOOTER, EASY 321 (K031315)Tmc Technology Corp.2003-09-04
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (K031857)Bayer Diagnostics Corp.2003-09-04
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (K032491)Imagyn Medical Technologies, Inc.2003-09-04
DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER (K030629)Dolphin Medical, Inc.2003-09-04
EBI XFIX DFS SYSTEM (K031919)Ebi, L.P.2003-09-04
ALEXANDER (K032493)Ivoclar Vivadent, Inc.2003-09-04
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K032457)Cordis Corp.2003-09-04
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (K032479)Howmedica Osteonics Corp.2003-09-04
WIROBOND C (K032136)Bego U.S.A.2003-09-04
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES (K031761)Synthes (Usa)2003-09-03
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (K032173)First Quality Hygienic, Inc.2003-09-03
MEDRO SPD (K030652)Usfilter/Ionpure, Inc.2003-09-03
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY (K032345)Accuray, Inc.2003-09-03
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS (K032622)Medtronic Vascular2003-09-03
MERIT MAK (MINI ACCESS KIT) (K031691)Merit Medical Systems, Inc.2003-09-03
PATHWAY ACCESS SHEATH CATHETER (K030662)Vertelink Corporation2003-09-03
EDWARDS DIRECTIONAL CATHETER (K030630)Edwards Lifesciences, LLC2003-09-03
HOMOCYSTEINE MICROTITER PLATE ASSAY (K032012)Diazyme Laboratories2003-09-03
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K031833)Medtronic Sofamor Danek2003-09-03
MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT (K030633)Medtronic Ave, Inc.2003-09-02
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT (K032156)Wfr/Aquaplast Corp.2003-09-02
I-STAT CARDIAC TROPONIN (CTNI) TEST (K031739)I-Stat Corporation2003-09-02
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 (K030328)bioMerieux, Inc.2003-09-02
VP-1000; MED CAM 100; VP-3000A; MED CAM 300 (K032544)Mgb Endoskopische Gerate GmbH (Berlin)2003-09-02
ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 (K032545)Mgb Endoskopische Gerate GmbH (Berlin)2003-09-02
DIGITAL IMAGER (K032022)Pyramid Medical, Inc.2003-09-02
SAFETYWAND DISPOSABLE HANDPIECE (K023722)Spintech, Inc.2003-09-02
ARKIT HBA1C (K030553)Arkray, Inc.2003-09-02
51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW (K032020)Iiyama Corporation2003-09-02
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM (K031729)Howmedica Osteonics Corp.2003-09-02
ACMI M4 TELESCOPES (K031758)Acmi Corporation2003-09-02
QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE (K032256)No 7 Contact Lens Laboratory , Ltd.2003-08-29
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM (K030742)Cryo Vascular Systems, Inc.2003-08-29
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP (K032213)Stockert Instrumente GmbH2003-08-29
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K032382)Trek Diagnostic Systems, Inc.2003-08-29
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (K030237)Kapp Surgical Instrument, Inc.2003-08-29
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS (K031730)Howmedica Osteonics Corp.2003-08-29
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER (K032409)Orthovita, Inc.2003-08-29
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT (K030441)Cook Ob/Gyn2003-08-29
IBL C1Q-CIC CIA TEST (K032254)Ibl GmbH2003-08-29
OMNIPRO I'MRT (K031634)Wellhofer Dosimetrie2003-08-29
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM (K032390)Ebi, L.P.2003-08-29
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031710)Aomori Olympus Co., Ltd.2003-08-29
IMSURE (K031975)Prodigm, Inc.2003-08-29
V SET (K020424)Hennig Enterprises Europe Srl2003-08-29
APLAB, MODEL 801D0030 (K030379)Sector Medical Corp.2003-08-29
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 (K030066)Nuclear Associates2003-08-29
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 (K031700)Medtronic Perfusion Systems2003-08-29
BINDER CO2 INCUBATOR SERIE CB (K032526)Binder GmbH2003-08-29
S2 NAIL SYSTEM (K032579)Howmedica Osteonics Corp.2003-08-29
V SET (K020419)P.T. Greenleaf2003-08-29
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 (K031694)Aspect Medical Systems, Inc.2003-08-29
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM (K024313)Pisharodi Surgicals, Inc.2003-08-29
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 (K031697)Schering-Plough Healthcare Products, Inc.2003-08-29
NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN (K032293)Sgmp Co., Ltd.2003-08-28
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING (K032294)Sgmp Co., Ltd.2003-08-28
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL (K032453)Bionostics, Inc.2003-08-28
INION OTPS BIODEGRADABLE PIN (K031712)Inion , Ltd.2003-08-28
BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (K032432)Busse Hospital Disposables, Inc.2003-08-28
JOBST TRAVEL SOCKS (K032325)Bsn-Jobst, Inc.2003-08-28
HEARTSTART MRX, MODEL M3535A (K031187)Philips Medical Systems2003-08-27
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES (K030525)Mid-Atlantic Diagnostics, Inc.2003-08-27
MOBILE BATTERY SERVICE STATION (MBSS) (K030898)Ad Elektronik GmbH2003-08-27
ELCACAM (K032070)A-Dec, Inc.2003-08-27
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS (K031665)Iridex Corp2003-08-27
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) (K032041)LeMaitre Vascular, Inc.2003-08-27
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT (K032360)Boston Scientific Corp2003-08-27
MICROPEAK (K030586)Micro Direct, Inc.2003-08-27
LCD MONITOR, RADIFORCE G11, G31, G51 (K032026)Eizo Nanao Corporation2003-08-27
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY (K023617)Microgenics Corp.2003-08-27
TSO3 OZONE CHEMICAL INDICATOR (K021161)Technologies of Sterilization With Oxone, Tso3, Inc.2003-08-27
KENTEX DISPOSABLE VAGINAL SPECULUM (K030693)Kentron Health Care, Inc.2003-08-27
CLICK HOLTER (K032276)Remco Italia S.P.A.2003-08-27
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA (K030381)Portex , Ltd.2003-08-27
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) (K032498)Straumann USA2003-08-27
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (K032069)AngioDynamics, Inc.2003-08-27
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML (K031984)Becton, Dickinson & CO2003-08-27
D-10 HEMOGLOBIN A1C (K031043)Bio-Rad Laboratories, Inc.2003-08-27
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES (K031748)Vitalcare Group, Inc.2003-08-27
OASYS-ORAL AIRWAY SYSTEM (K030440)Mark Abramson, D.D.S., Inc.2003-08-26
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER (K032376)AngioDynamics, Inc.2003-08-26
VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES (K031740)Welch Allyn Protocol, Inc.2003-08-26
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR (K032272)Est International Corporation2003-08-26
UROPOWER (K022721)W.O.M. World of Medicine AG2003-08-26
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 (K032250)Edwards Lifesciences, LLC2003-08-26
MODIFICATION TO OUTBACK CATHETER (K032298)Lumend, Inc.2003-08-26
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K031678)Guidant Corp.2003-08-26
DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K032236)Est International Corporation2003-08-26
DISPOSABLE N-PE MICKROKERATOME BLADES (K032297)Oasis Medical, Inc.2003-08-26
TSO3 OZONE STERILIZER, MODEL 125L (K020875)Technologies of Sterilization With Oxone, Tso3, Inc.2003-08-26
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL (K032415)Usa Instruments, Inc.2003-08-25
NEUROTECH BAXOLVE TYPE 294 (K023913)Bio-Medical Research, Ltd.2003-08-25
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K031921)Cliniqa Corporation2003-08-25
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE (K030980)Dentaurum2003-08-25
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL (K032474)Usa Instruments, Inc.2003-08-25
VISUALINE METHADONE DIPSTRIPTEST (K023856)Sun Biomedical Laboratories, Inc.2003-08-25
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Every clearance here is in the API, with alerts when new ones post.