Atlas FDA

2004

3,373 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE (K030739)Infusion Dynamics, Inc.2004-01-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K033560)Becton, Dickinson & CO2004-01-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE (K033557)Becton, Dickinson & CO2004-01-14
MODIFICATION TO V-CATH POLY PICC (K033853)Hdc Corp.2004-01-14
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) (K031908)Med2000 S.R.L.2004-01-14
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 (K032245)Arthrex, Inc.2004-01-14
NASAL-AIR CRITICAL CARE (K031896)Innomed Technologies2004-01-14
BARD ELIMINATOR PET BALLOON DILATORS (K033936)C.R. Bard, Inc.2004-01-14
MED-LOGICS, MODEL ML7090 (K033293)Med-Logics, Inc.2004-01-13
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING (K033323)Dideco S.P.A.2004-01-13
IBL C3D-CIC EIA TEST (K032796)Ibl GmbH2004-01-13
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM (K033556)Synthes (Usa)2004-01-13
THE ANSWER SCREW SUPPLEMENTATION SYSTEM (K032966)Simplicity Orthopedic Solutions, LLC2004-01-13
FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH (K033569)Flowmedica, Inc.2004-01-13
SURGICAL MEDICAL DEVICE CAUTERY (K023506)Modern Medical Equipment Mfg., Ltd.2004-01-13
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM (K033312)Ebi, L.P.2004-01-13
MODIFICATION TO JET-X HA COATED HALF PINS (K033289)Smith & Nephew, Inc.2004-01-13
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE (K033850)Medtronic Neurosurgery2004-01-13
ENDOPURE ROOT CANAL CLEANSER (K032361)Dentsply Intl.2004-01-12
BOSTON SCIENTIFIC V-18 CONTROL WIRE (K033742)Boston Scientific Corp2004-01-12
ROCHE ONLINE TDM LIDOCAINE (K032334)Roche Diagnostics Corp.2004-01-12
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 (K033525)Dade Behring, Inc.2004-01-12
ROCHE ONLINE TDM QUINIDINE (K032332)Roche Diagnostics Corp.2004-01-12
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM (K033286)Orthopedic Designs, Inc. (Odi)2004-01-12
BIOCENTREX CARDIAC PANEL (K033155)Biocentrex2004-01-12
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K033929)Intra Luminal Therapeutics, Inc.2004-01-12
ACL TOP MODEL, TOP (K033414)Instrumentation Laboratory CO2004-01-12
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (K031147)Ethicon Endo-Surgery, Inc.2004-01-12
MEDICAL MAGGOTS (K033391)Ronald A. Sherman2004-01-12
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS (K033372)Micro Therapeutics, Inc.2004-01-09
SPIRIT 5000 CARDIAC COIL (K033490)Usa Instruments, Inc.2004-01-09
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT (K032710)Apogee Medical, Inc.2004-01-09
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 (K033830)Opticon Medical, Inc.2004-01-09
DIAMOND SETUP 2000 (K032886)K&S Assoc., Inc.2004-01-09
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P (K032051)Access Battery, Inc.2004-01-09
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L (K033377)Fujifilm Medical System U.S.A., Inc.2004-01-09
PREPAIR (K033215)Danville Materials, Inc.2004-01-09
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM (K032585)Ron-Tech Medical , Ltd.2004-01-09
ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357)Philips Medical Systems (Cleveland), Inc.2004-01-09
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR (K033683)Smart Glove Corp. Sdn Bhd2004-01-08
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 (K032822)Asap Endoscopic Products GmbH2004-01-08
ARIOL HER-2/NEU IHC (K031715)Applied Imaging Corp.2004-01-08
PROMOS SHOULDER (K032126)Plus Orthopedics2004-01-08
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2 (K033817)Microlife Intellectual Property GmbH2004-01-08
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS (K031962)Implex Corp.2004-01-08
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR (K033539)Shen Wei (Usa), Inc.2004-01-08
PRECISION XCEED DIABETES MONITORING SYSTEM (K033845)Abbott Laboratories2004-01-08
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290 (K033818)Microlife Intellectual Property GmbH2004-01-08
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (K034003)Philips Ultrasound, Inc.2004-01-08
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (K034013)Corgenix, Inc.2004-01-08
CO2 CALIBRATOR/DILUENT (K033643)Bayer Healthcare, Diagnostics Division2004-01-08
PINNACLE REVISION SYSTEM (K033338)DePuy Orthopaedics, Inc.2004-01-08
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM (K033837)Howmedica Osteonics Corp.2004-01-08
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS (K033987)Dideco S.P.A.2004-01-08
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM (K033922)Institut Straumann AG2004-01-07
SEA-BAND (K033268)Sea-Band UK , Ltd.2004-01-07
LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES (K033535)Lumend, Inc.2004-01-07
STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (K033660)Rudolf Storz GmbH2004-01-07
ELECSYS PRECICONTROL MULTIANALYTE (K033937)Roche Diagnostics Corp.2004-01-07
PREMIER PLUS (K032003)American Imex2004-01-07
GENESIS VERTICAL PLATFORM LIFT (K033469)Garaventa Accessibility2004-01-07
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES (K033449)Professional Dental Technologies Therapeutics, Inc.2004-01-07
OSTEOMED ORTHODONTIC SCREW SYSTEM (K031936)Osteomed LP2004-01-07
SPINEASSIST DEVICE (K033413)Mazor Surgical Technologies , Ltd.2004-01-07
VNUS VESSEL AND TISSUE COAGULATION SYSTEM (K033547)Vnus Medical Technologies, Inc.2004-01-07
COMPREHENSIVE NEUROMUSCULAR PROFILER (K031995)Medical Technologies Unlimited, Inc.2004-01-07
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES (K033475)Nihon Kohden America, Inc.2004-01-07
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K032031)Intra Luminal Therapeutics, Inc.2004-01-07
CODA CX1 MOTION ANALYSIS SYSTEM (K033514)Charnwood Dynamics , Ltd.2004-01-06
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK (K033659)Varian, Inc.2004-01-06
OMNILINK .018 BILIARY STENT SYSTEM (K033834)Guidant Corp.2004-01-02
NOVA GLUCOSE CONTROL SOLUTIONS (K033433)Nova Biomedical Corp.2004-01-02
HEMOSIL LIQUID ANTITHROMBIN XL (K033775)Instrumentation Laboratory CO2004-01-02
← Previous

Track 2004 automatically

Every clearance here is in the API, with alerts when new ones post.