Atlas FDA

2003

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

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RecordFirmDate
LITTLE COACH (K030759)Wheelchair & Scooter Express2003-05-01
PASCO MIC AND MIC/ID PANELS (K030933)Pasco Laboratories, Inc.2003-05-01
SMALL VOLUME NEBULIZER (K023602)Allegiance Healthcare Corporation2003-05-01
SUNPEX TECHNOLOGIES MODEL PW (K024175)Sunpex Technology Co., Ltd.2003-05-01
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA (K030741)Hycor Biomedical , Ltd.2003-05-01
MEDIPALM-20 (K031202)Braebon Medical Corp.2003-05-01
NIOX ARTICLE NO: 02-1000 (DEN030001)Aerocrine AB2003-04-30
'RAPIDTEC'-5M-MULTIPLE DIP TEST (K023869)American Bio Medica Corp.2003-04-30
AQUASENS FLUID MONITORING SYSTEM (K031213)Davol, Inc.2003-04-30
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS (K030690)Codonics, Inc.2003-04-30
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE (K031185)Abbott Laboratories2003-04-30
HEMO-STREAM HEMODIALYSIS CATHETER SET (K023847)Rex Medical2003-04-30
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT (K030415)AngioDynamics, Inc.2003-04-30
ATHENA PELVIC MUSCLE TRAINER (K023905)Athena Feminine Technologies, Inc.2003-04-30
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE (K030451)Carbon Medical Technologies, Inc.2003-04-30
DEROYAL DRAPES, STERILE, NON-STERILE (K030365)Deroyal Industries, Inc.2003-04-29
X O ODONTOSURGE 4 (K023672)Xo Care A/S2003-04-29
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K020418)P.T. Greenleaf2003-04-29
SYNCHRON SYSTEMS OPIATE REAGENT (K031002)Beckman Coulter, Inc.2003-04-29
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR (K021174)Imagyn Surgical2003-04-29
CARBODISSECTING ENDOSCOPE (K020925)Endo Surgical Devices, Inc.2003-04-29
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K020421)Hennig Enterprises Europe Srl2003-04-29
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE (K030303)Cryocath Technologies, Inc.2003-04-29
SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE (K030133)Dentalez Group2003-04-29
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (K030405)Seradyn2003-04-28
MICROALBUMIN REAGENT SET AND CALIBRATORS (K023860)Pointe Scientific, Inc.,2003-04-28
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (K030942)Medical Analysis Systems, Inc.2003-04-28
COZART EIA COCAINE ORAL FLIUD KIT (K030234)Cozart Bioscience , Ltd.2003-04-28
ROCHE ONLINE TDM PHENYTOIN (K030428)Roche Diagnostics Corp.2003-04-28
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM (K031009)Bio-Logic Systems Corp.2003-04-28
ORTHOPEDIC WIRE (K031127)Howmedica Osteonics Corp.2003-04-28
SCULPTING RESIN (K030585)Bisco, Inc.2003-04-28
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K031028)Bioplate, Inc.2003-04-28
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (K023991)Precision Biologic2003-04-28
FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 (K030297)Enraf-Nonius, B.V.2003-04-28
DEROYAL GOWNS, STERILE, NON-STERILE (K030364)Deroyal Industries, Inc.2003-04-28
FLAT PANEL DISPLAY, ME183L (K030272)Totoku Electric Co., Ltd.2003-04-25
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS (K030353)Eagle Vision, Inc.2003-04-25
FLAT PANEL DISPLAYS, CDL SERIES (K030276)Totoku Electric Co., Ltd.2003-04-25
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 (K030974)Baxter Healthcare Corp2003-04-25
MEDICAL FLAT PANEL DISPLAY, ME315L (K030274)Totoku Electric Co., Ltd.2003-04-25
APNEACHECK (K022294)Im Systems2003-04-25
TRAVELSOME STANDARD (K030233)Sim Italia S.R.L.2003-04-25
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY (K030983)Deltec, Inc.2003-04-25
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 (K030959)Laser Peripherals, LLC2003-04-25
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 (K030975)Baxter Healthcare Corp2003-04-25
MODIFICATION TO MODULAR PLUS REVISION STEM (K030971)Plus Orthopedics2003-04-24
QUANTA PLEX ENA PROFILE 5 (K030681)Inova Diagnostics, Inc.2003-04-24
AMATOMICAL SHOULDER WITH REMOVABLE HEAD (K030259)Centerplus Orthopedics, Inc.2003-04-24
MODIFICATION TO XIA STAINLESS STEEL SYSTEM (K031090)Howmedica Osteonics Corp.2003-04-24
5F MEDTRONIC LAUNCHER GUIDE CATHETER (K030779)Medtronic Vascular2003-04-24
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205)Biotronik, Inc.2003-04-24
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS (K030979)DePuy Orthopaedics, Inc.2003-04-24
SAFFRON NM GUIDING CATHETER (K030715)Neich Medical (Shenzhen) Company Limited2003-04-24
A127 LEAD EXTENSION (K030461)Advanced Neuromodulation Systems2003-04-24
C. DIFFICILE TOX A/B II (K030404)Techlab, Inc.2003-04-24
IMPACT SUTURE ANCHOR. MODEL 433510 (K030388)Bionx Implants, Ltd.2003-04-24
EDWARDS INTRODUCER SHEATH (K031087)Edwards Lifesciences, LLC2003-04-24
BATTERY, RECHARGEABLE (K030261)Access Battery, Inc.2003-04-24
VERITAS COLLAGEN MATRIX (K030879)Synovis Surgical Innovations2003-04-24
RADII (K030568)Southern Dental Industries, Inc.2003-04-24
Z-BOX (K030764)Z-Kat, Inc.2003-04-24
HL888JF (K030541)Health & Life Co., Ltd.2003-04-24
APPLANATION TONOMETER (K023676)Optilasa, S.L.2003-04-24
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM (K030595)Blackstone Medical, Inc.2003-04-24
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT (K030984)Intra Luminal Therapeutics, Inc.2003-04-24
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 (K030243)Imtec Corp.2003-04-23
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO (K023256)Abbott Laboratories2003-04-23
VTI 20 MHZ GATED DOPPLER (K031091)Vascular Technology Incorporated2003-04-23
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES (K023454)Datex-Ohmeda2003-04-23
AXCEL SURGICAL LIGHT (K030906)Alm2003-04-23
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 (K024342)Daito Co., Ltd.2003-04-23
F1 DIODE LASER SYSTEM (K030235)Opus Medical, Inc.2003-04-23
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK (K030937)Arrow International, Inc.2003-04-23
VITALCARE URETHRAL CATHETER (K021938)Vitalcare, Inc.2003-04-22
STEELEX ELECTRODE SET (K030556)Aesculap, Inc.2003-04-22
MODIFICATION TO HIOX (K030943)Sensor Medics Corp.2003-04-22
BABY POD (K030283)Prism Enterprises, Inc.2003-04-22
MASTERGRAFT MATRIX (K023553)Medtronic Sofamor Danek, Inc.2003-04-22
WORRY-REMOVER IRRIGATOR (K030056)Corisen Group, Ltd.2003-04-22
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM (K030310)Synthes (Usa)2003-04-22
VITALCARE FOLEY CATHETER (K021939)Vitalcare, Inc.2003-04-22
INSORB ABSORBABLE STAPLES, MODEL SP-B20 (K024117)Incisive Surgical, Inc.2003-04-22
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (K030129)Endocardial Solutions, Inc.2003-04-22
NOVAVISION, MODEL 2.0 (K023623)Novavision, Inc.2003-04-22
COULTER LH 750 BODY FLUIDS APPLICATION (K030606)Beckman Coulter, Inc.2003-04-21
NICOLET PIONEER TC8080 (K020754)Nicolet Biomedical2003-04-21
HANSON MEDICAL CALF IMPLANT (K030808)Hanson Medical, Inc.2003-04-21
IBD-QUIK CHEK (K030704)Techlab, Inc.2003-04-21
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K030782)W. L. Gore & Associates, Inc.2003-04-21
T-SCIENTIFIC T-PAD (K030334)T-Scientific, Inc.2003-04-21
HANSON MEDICAL GLUTEAL IMPLANT (K030809)Hanson Medical, Inc.2003-04-21
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER (K030203)Long Well Electronics Corp.2003-04-21
RITA STARBURST SDE ELECTROSURGICAL DEVICE (K030967)Rita Medical Systems2003-04-21
MODIFICATION TO STRYKER PAINPUMP2 (K030885)Stryker Instruments2003-04-18
HP-3 HD ELECTRIC WHEELCHAIR (K030427)Imc-Heart Way LLC2003-04-18
MINIPHYSIONIZER 2.0 AND ELECTRODES (K022950)Physion, Inc.2003-04-18
VECTORSONIC, MODEL VU-270 (K030880)Metron Medical Australia, Pty, Ltd.2003-04-18
LEFORTE SYSTEM BONE SCREW (K023365)Jeil Medical Corporation2003-04-18
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON (K030231)Sorin Group Italia S.R.L.2003-04-18
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Every clearance here is in the API, with alerts when new ones post.