Atlas FDA

2003

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

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RecordFirmDate
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES (K032147)Alaris Medical Systems, Inc.2003-07-25
DPX SERIES BRAVO DUO BONE DENSITOMETER (K030962)Ge Lunar Corp.2003-07-25
MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR (K030221)Mytech Technology Co., Ltd.2003-07-25
VINYL EXAM GLOVES, POWDER-FREE, YELLOW (K031854)Shanghai Jiawang Industrial Co. , Ltd.2003-07-25
EXCEL PRIMARY SOLUTION SET (K031500)Exelint Intl. Co.2003-07-25
THYRO TEST (K030912)Thryotec2003-07-25
ELI 200+ AUDICOR (K031182)Mortara Instrument, Inc.2003-07-25
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE (K031394)American Syringe Company2003-07-25
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE (K031580)Green Prospect Sdn Bhd2003-07-25
UC-PLUS SOLUTION UNICONDYLAR KNEE (K032052)Plus Orthopedics2003-07-25
RECOVERY FILTER SYSTEM, MODEL RF-048F (K031328)C.R. Bard, Inc.2003-07-25
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 (K031981)Linvatec Biomaterials, Ltd.2003-07-25
OXINIUM FEMORAL HEADS (K030766)Smith & Nephew, Inc.2003-07-25
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K031554)Genzyme Biosurgery2003-07-25
STAINLESS STEEL AQUATIC WHEELCHAIR (K031910)Db Perks & Associates , Ltd.2003-07-25
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT (K031999)Elekta Instrument AB2003-07-25
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM (K031980)Elekta Instrument AB2003-07-25
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT (K031979)Conmed Integrated Systems (Cmis)2003-07-25
GE LOGIQ 7, MODEL 2354858 (K032182)General Electric Co.2003-07-25
STRYKER PLATING SYSTEM PERIARTICULAR PLATES (K031959)Howmedica Osteonics Corp.2003-07-25
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM (K032059)Aesculap, Inc.2003-07-25
MC2X MULTI-STAGE VENOUS CANNULA (K031776)Medtronic Perfusion Systems2003-07-25
TINNITUS RX (K031624)Tinnitus Control, Inc.2003-07-24
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS (K031986)Ics Medical2003-07-24
THERIFIL BONE FILLER (K031040)Therics, Inc.2003-07-24
KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 (K032081)Kavo America2003-07-24
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR (K031837)Spinal Concepts, Inc.2003-07-24
HOFFMANN II COMPACT BALTIMORE COUPLING (K031941)Howmedica Osteonics Corp.2003-07-24
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A (K032174)Wide Corporation2003-07-24
NOBEL DIRECT, MODELS 30937, 30938 (K031345)Nobel Biocare Uas, Inc.2003-07-24
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG (K031581)Green Prospect Sdn Bhd2003-07-24
MEGATECH SCIENTIFIC FACE MASK (K030239)Megatech Scientific Pte, Ltd.2003-07-24
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER (K032013)Beckman Coulter, Inc.2003-07-24
MODEL J-5 MVO-MONITOR (K031998)Myotronics-Noromed, Inc.2003-07-24
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K031648)Olympus Optical Co., Ltd.2003-07-24
RAPIDO CUT-AWAY CUTTER (K031459)Guidant Corp.2003-07-23
EMIT II PLUS COCAINE METABOLITE ASSAY (K031512)Dade Behring, Inc.2003-07-23
CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 (K031920)Trans Vascular Incorporated2003-07-23
PICOSAT II SPO2 PULSE OXIMETRY MODULE (K030973)Philips Medical Systems2003-07-23
SCANLUBE (K031222)Sonotech, Inc.2003-07-23
MODEL 9600, AVANT PULSE OXIMETER (K023044)Nonin Medical, Inc.2003-07-23
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 (K031390)Minimed, Inc.2003-07-23
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE (K031256)Olympus Opto-Electronics Co., Ltd.2003-07-23
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS (K031575)Cliniqa Corporation2003-07-23
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 (K031173)Needle Tech Products, Inc.2003-07-23
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION (K014074)Hoffrichter GmbH2003-07-23
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A (K032103)Philips Medical Systems2003-07-22
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER (K031161)Biosense Webster, Inc.2003-07-22
EBI SPINELINK SPINAL FIXATION SYSTEM (K031424)Ebi, L.P.2003-07-22
EKOS PERIPHERAL INFUSION SYSTEM (K030637)Ekos Corp.2003-07-22
EBI SPINELINK - II SPINAL FIXATION SYSTEM (K031355)Ebi, L.P.2003-07-22
BRODA MODEL 587 MANUAL WHEELCHAIR (K032133)Broda Ent., Inc.2003-07-21
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K030442)C.R. Bard, Inc.2003-07-21
FAST THROW STAINLESS STEEL SURGICAL SUTURE (K030926)Advanced Surgical Products, Inc.2003-07-21
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES (K030033)Lumenis, Ltd.2003-07-21
DUNLEE FORMAT COLLIMATOR FAMILY (K031597)Philips Medical Systems North America Co.2003-07-21
ENDOS DC (K030634)Villa Sistemi Medicali S.P.A.2003-07-21
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) (K031085)Gyrus Medical, Inc.2003-07-21
AMPLAID A756 SCREENING ADMITTANCE METER (K031978)Amplaid2003-07-21
SAPPHIRE DETACHABLE COIL SYSTEM (K030392)Micro Therapeutics, Inc.2003-07-21
ORLON NONABSORABLE SURGICAL SUTURE USP (K030177)Sri Orion Pharmaceuticals & Sutures2003-07-21
CARDIOVATIONS RETRACTOR (K031847)ETHICON, Inc.2003-07-21
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM (K032114)Siemens Medical Solutions USA, Inc.2003-07-21
CORIX 70 PLUS-USV (K031802)Coramex, S.A.2003-07-21
SLED CURING LIGHT SYSTEM (K031615)Dentsply International2003-07-21
SITE-RITE IV ULTRASOUND SYSTEM (K032135)Dymax Corp2003-07-21
MODIFICATION TO STRYKER PAINPUMP (K031249)Stryker Instruments2003-07-21
CARDIOVATIONS OPTICAL BIPOLAR DEVICE (K031846)ETHICON, Inc.2003-07-21
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML (K031912)Becton, Dickinson & CO2003-07-21
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION (K031638)Electromed Imaging, Inc.2003-07-21
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 (K024377)Kalaco Scientific, Inc.2003-07-21
PHILIPS VIEWFORUM 2003 (K032096)Philips Medical Systems2003-07-18
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT (K031057)Portex, Inc.2003-07-18
MODIFICATION TO WBR, MODEL HR (K031874)U.C.G. Technologies , Ltd.2003-07-18
PRIMA III TOTALSENSE TORSO COIL (K031365)Usa Instruments, Inc.2003-07-18
PROVIDENCE MOLDING HELMET (K030669)Northeast Orthotics and Prothetics, Inc.2003-07-18
SCANTEC PAD (K031894)Sonotech, Inc.2003-07-18
BRAIN COIL, MODEL 9900GE-64 (K031536)Clinical MR Solutions, LLC2003-07-18
MODIFICATION TO COOK ZILVER BILIARY STENT (K031821)Cook, Inc.2003-07-18
HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS (K031477)Ocular Sciences, Inc.2003-07-18
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX (K031504)Koven Technology, Inc.2003-07-18
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A (K031631)3D Line USA, Inc.2003-07-18
ACUSON CV70 CARDIOVASCULAR SYSTEM (K032111)Siemens Medical Solutions USA, Inc.2003-07-18
APEEL CS CATHETER DELIVERY SYSTEM (K031906)St Jude Medical2003-07-18
DIADEXUS PLAC TEST (K030477)Diadexus, Inc.2003-07-18
RADIUS 018 COUGAR WIRE (K032129)Radius Medical Technologies, Inc.2003-07-17
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS (K030342)Lumenis, Ltd.2003-07-17
LORDEX POWER TRACTION EQUIPMENT (K031227)Ever Prosperous Instrument, Inc.2003-07-17
POLYGRAFT BONE GRAFT SUBSTITUTE (K030288)Osteobiologics, Inc.2003-07-17
ELECTROMEDICARIN 900 (K020478)Electromedicarin, S.A.2003-07-17
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM (K030087)Spinal Concepts, Inc.2003-07-17
COBAS INTEGRA CARBON DIOXIDE ASSAY (K031879)Roche Diagnostics Corp.2003-07-17
ACUMED SMALL BONE LOCKING ROD SYSTEM II (K031438)Acumed, LLC2003-07-17
TAGA VELOCITY HUMIDIFIER (K031179)Taga Medical Technologies, Inc.2003-07-17
GALT MEDICAL GUIDEWIRE (K031916)Galt Medical Corp.2003-07-17
NATURALASE LP ND:YAG LASER (K031828)Focus Medical, LLC2003-07-17
MENTOR OBTAPE TRANS-OBTURATOR TAPE (K031767)Mentor Corp.2003-07-17
OMNILUX RED (K030426)Photo Therapeutics Limited2003-07-17
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM (K031893)Howmedica Osteonics Corp.2003-07-17
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM (K031247)Medtronic Vascular2003-07-17
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Every clearance here is in the API, with alerts when new ones post.