Atlas FDA

2003

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

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RecordFirmDate
MODIFICARION TO WACKERS-LIU CQ SOFTWARE (K032500)Eclipse Systems, Inc.2003-08-25
SONIK LDI 20 AIR (K030374)Evit Labs, Inc.2003-08-25
EASY PULSE II OXYGEN CONSERVER (K032018)Precision Medical, Inc.2003-08-25
STARBOND DENTAL BONDING ALLOYS (K032106)Star Refining Precious Metals South Africa2003-08-25
MITEK MICRO QUICKANCHOR (K032078)Mitek Worldwide2003-08-25
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 (K032203)Hemocue, Inc.2003-08-25
LYRA NASAL MASK (K031883)Sensor Medics Corp.2003-08-25
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE (K030977)Dentaurum2003-08-25
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 (K032341)Sota Precision Optics, Inc.2003-08-25
MATCH PRESS PRESSABLE CERAMIC (K024250)Davis Schottlander & Davis, Ltd.2003-08-25
STRYKER SPINE OASYS BONE SCREW (K031657)Howmedica Osteonics Corp.2003-08-22
INNOVA 3100 (K031637)GE Medical Systems2003-08-22
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 (K032464)Wrp Asia Pacific Sdn. Bhd.2003-08-22
ANKYLOS (K012681)Dentsply Ceramco2003-08-22
SPIDERVIEW (K032466)Ela Medical, Inc.2003-08-22
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER (K032503)Hitachi Medical Systems America, Inc.2003-08-22
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 (K032005)Medtronic Minimed2003-08-22
TRAXIS CEMENT RESTRICTOR (K031318)Spinal Concepts, Inc.2003-08-22
VITEK 2 GRAM POSITIVE GATIFLOXACIN (K032314)bioMerieux, Inc.2003-08-22
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (K023400)Fci Ophthalmics, Inc.2003-08-22
INTERMED ZOOM COLPOSCOPE (K031639)Intermed Group, Inc.2003-08-22
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (K030860)Monobind2003-08-22
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 (K031692)Intra Luminal Therapeutics, Inc.2003-08-22
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (K022587)Medtrade Products , Ltd.2003-08-22
ROCHE ONLINE TDM VALPROIC ACID (K032049)Roche Diagnostics Corp.2003-08-22
VERSATREK (K032306)Trek Diagnostic Systems, Inc.2003-08-22
VIATRONIX V3D EXPLORER, REVISION 1.2 (K032483)Viatronix, Inc.2003-08-22
ALTATEC CERAMIC ABUTMENT (K032448)Altatec Biotechnologies2003-08-22
Trellis Reserve Infusion System (K032261)Bacchus Vascular, Inc.2003-08-22
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 (K032068)Cardiovention, Inc.2003-08-22
OSTEOMED SUBTALAR IMPLANT SYSTEM (K031155)Osteomed LP2003-08-22
14G CORMARK BIOPSY SITE IDENTIFIER (K032217)Artemis Medical, Inc.2003-08-21
BIOMARC TISSUE MARKER (K032347)Carbon Medical Technologies, Inc.2003-08-21
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551 (K031907)Norm Pacific Automation Corp.2003-08-21
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER (K030574)Glustitch, Inc.2003-08-21
LINVATEC 300W XENON LIGHT SOURCE (K031994)Linvatec Corp.2003-08-21
DENTAPORT ZX (K031204)J. Morita USA, Inc.2003-08-21
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC (K032057)Branan Medical Corp.2003-08-21
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 (K032285)Olympus America, Inc.2003-08-21
COLUMBUS (PS) (K030367)Aesculap, Inc.2003-08-21
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 (K032452)Stellartech Research Corp.2003-08-21
CENTURION SES EPIKERATOME (K031735)Ciba Vision Corporation2003-08-21
MODEL 120 SERIES MATERNAL/FETAL MONITOR (K032252)Ge Medical Systems Information Technologies2003-08-21
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS (K031954)New Star Lasers, Inc.2003-08-21
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K032282)Implex Corp.2003-08-21
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT (K032295)Smith & Nephew, Inc.2003-08-21
SYNTHES (USA) CALVICLE HOOK PLATE (K031677)Synthes (Usa)2003-08-21
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID (K032377)Roche Diagnostics Corp.2003-08-21
ARTHROCARE SYSTEM (K032504)Arthrocare Corp.2003-08-21
QSC-127 SHOULDER ARRAY COIL SET (K032429)Mri Devices Corp.2003-08-21
NOMOS CORVUS 5.0M (K032209)Nomos Corp.2003-08-21
BODYGUARD INFUSION SYSTEM (K031749)Caesarea Medical Electronics , Ltd.2003-08-21
SHIMADZU COLLIMATOR R-30H (K031771)Shimadzu Corp.2003-08-21
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 (K032490)Toshiba America Medical Systems, In.C2003-08-21
NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 (K032301)Neogen Technologies, Inc.2003-08-21
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX (K031885)Image-Guided Neurologics, Inc.2003-08-21
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS (K032396)Biomet, Inc.2003-08-21
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 (K032090)Mri Devices Corp.2003-08-21
DESIGNS FOR VISION FIBEROPTIC LIGHT (K032283)Designs For Vision, Inc.2003-08-20
S & C -BRACKET ADHESIVES (K031420)S & C Polymer GmbH2003-08-20
NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) (K031551)Vyteris, Inc.2003-08-20
EP-WORKMATE WITH RPM SYSTEM (K032225)Ep Medsystems2003-08-20
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K032204)Vascular Solutions, Inc.2003-08-20
ELECSYS PRECICONTROL TROPONIN T (K031990)Roche Diagnostics Corp.2003-08-20
PERFECT CAPSULE (K030957)Milvella Pty. , Ltd.2003-08-20
CRYOTRON 2 CRYOTHERAPY DEVICE (K030281)Cryonic Medical North America2003-08-20
QUANTIX/OR DEVICE (K030357)Cardiosonix, Ltd.2003-08-20
ELECYS SHBG CALCHECK (K031698)Roche Diagnostics Corp.2003-08-20
MODIFICATION ORIA SPINAL SYSTEM (K023884)Ortho Tec, LLC2003-08-20
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM (K032191)Luxsano AB2003-08-20
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE (K023902)Usgi Medical, Inc.2003-08-20
TISSUELINK FLOATING BALL MODEL 23-201-1 (K032132)Tissuelink Medical, Inc.2003-08-20
ISM1+, IMS2+, AND UTM+ (K030490)Medicult A/S2003-08-20
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (K032198)Aesculap, Inc.2003-08-20
SAPPHIRE DETACHABLE FIBER COILS (K031852)Micro Therapeutics, Inc.2003-08-20
COBRA COOLED SURGICAL PROBE, MODEL M004159670 (K032207)Boston Scientific Corp2003-08-20
DUET SYSTEM (K030192)Bioview , Ltd.2003-08-20
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) (K032077)Seal Polymer Industries Bhd.2003-08-19
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S (K031917)Medtronic Minimed2003-08-19
ADVISOR, MODEL 9200 (K030407)Bci, Inc.2003-08-19
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE (K032011)Pt. Wrp Buana Multicorpora2003-08-19
PASCO MIC AND MIC/ID PANELS (K032259)Bd Diagnostic Systems2003-08-19
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 (K031427)Biomedical Life Systems, Inc.2003-08-19
PITANGA (K031489)Syneron Medical, Ltd.2003-08-19
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (K032335)Medical Analysis Systems, Inc.2003-08-19
NX SYSTEM (K030222)American Telecare, Inc.2003-08-19
SIROTORQUE L (K031584)Sirona Dental Systems GmbH2003-08-19
MIRAGE VISTA MASK (K031047)Resmed, Ltd.2003-08-19
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 (K031566)Baxter Healthcare Corp2003-08-19
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS (K031433)Siemens Medical Solutions USA, Inc.2003-08-19
VAXCEL PORT, MODELS 45-336 AND 45-338 (K032375)Boston Scientific Corp2003-08-19
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE (K032010)Pt. Wrp Buana Multicorpora2003-08-19
JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET (K030479)Jms North America Corp.2003-08-18
FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (K030730)Diagnostics Biochem Canada, Inc.2003-08-18
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS (K032131)Becton, Dickinson & CO2003-08-18
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K032287)Beckman Coulter, Inc.2003-08-18
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER (K031742)Bci, Inc.2003-08-18
PEM 2400 PET SCANNER (K032063)Pem Technologies2003-08-18
STERRAD 200 STERILIZER (K030429)Advanced Sterilization Products2003-08-18
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL (K032168)W. L. Gore & Associates, Inc.2003-08-15
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Every clearance here is in the API, with alerts when new ones post.