Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 (K023264)Alaris Medical Systems, Inc.2002-12-19
VIABIL BILIARY ENDOPROSTHESIS (K014215)W. L. Gore & Associates, Inc.2002-12-19
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (K023280)Olympus Optical Co., Ltd.2002-12-19
ECHO SOUNDER, ES-102EX (K023143)Koven Technology, Inc.2002-12-19
STEELEX STERNUM SET (K023411)Aesculap, Inc.2002-12-19
TRANSITIONAL IMPLANTS (K021915)Intra-Lock International2002-12-19
ACELL UBM LYOPHILIZED WOUND DRESSING (K021637)Acell, Inc.2002-12-19
ALOKA SSD-3500 ULTRASOUND SYSTEM (K023996)Aloka Co., Ltd.2002-12-18
JEWEL CAST PLUS (K023502)Pentron Laboratory Technologies2002-12-18
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B (K023119)Arthrex, Inc.2002-12-18
ANTI-SNORING DEVICE OR ASD (K011723)Pi Medical2002-12-18
COALESCENT U-CLIP- AND ACCESSORIES (K023125)Coalescent Surgical2002-12-18
OCCLUFAST ROCK (K024034)Zhermack S.P.A.2002-12-18
BURETTE-IN LINE (150 ML) (K023595)Tuta Healthcare Pty Limited2002-12-18
GOLD CORE 35 (K023501)Pentron Laboratory Technologies2002-12-18
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA (K022945)Hycor Biomedical, Inc.2002-12-18
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA (K022944)Hycor Biomedical, Inc.2002-12-18
ST AIA-PACK CEA ENZYME IMMUNOASSAY (K023893)Tosoh Medics, Inc.2002-12-18
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR (K024025)Kossan Latex Industries(M)Sdn Bhd2002-12-18
TERUMO SYRINGE WITH/WITHOUT NEEDLE (K023271)Terumo Medical Corp.2002-12-18
GROSHONG NXT DUAL LUMEN PICC CATHETERS (K023374)C.R. Bard, Inc.2002-12-18
DFA RESPIRATORY VIRUS SCREENING & ID KIT (K022713)Diagnostic Hybrids, Inc.2002-12-18
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE (K023225)Puritan Bennett Corp.2002-12-18
LAPARETTE, MODEL LAP J L S H N (K022979)Instruments Medicaux G.B., Inc.2002-12-18
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE (K023702)Ningbo Tianshun Rubber Products Co., Ltd.2002-12-18
ANDREWS INTRODUCER, MODEL ASI01 (K023173)Andrews Surgical Innovations, Ltd.2002-12-18
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K024026)Shanghai PM Plastics Enterise Co., Ltd.2002-12-18
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K024102)Allegiance Healthcare Corp.2002-12-18
ACE VERSANAIL (K023115)DePuy Orthopaedics, Inc.2002-12-18
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM (K024108)Siemens Medical Solutions USA, Inc.2002-12-18
ZETAPLUS SOFT (K024041)Zhermack S.P.A.2002-12-18
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER (K023907)Cordis Corp.2002-12-18
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (K022028)Vascular One, Inc.2002-12-17
IMMULITE 2000 ALLERGEN-SPECIFIC IGE (K023152)Diagnostic Products Corp.2002-12-17
JOSTRA MECC SYSTEM (K023132)Jostra AG2002-12-17
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 (K020683)Ati Medical, Inc.2002-12-17
UNIVERSAL CMF SYSTEM (K022185)Stryker Instruments2002-12-17
ST AIA-PACK TESTOSTERONE ASSAY (K023091)Tosoh Medics, Inc.2002-12-17
ST AIA-PACK AFP ENZYME IMMUNOASSAY (K023894)Tosoh Medics, Inc.2002-12-17
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 (K023867)Medical Analysis Systems, Inc.2002-12-17
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022177)Bayer Diagnostics Corp.2002-12-17
IRIDIS OPHTHALMIC PHOTOCOAGULATOR (K023094)Quantel Medical2002-12-17
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 (K023185)Sulzer Carbomedics, Inc.2002-12-17
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED (K023560)Shanghai Palomar Mountain Industries, Inc.2002-12-17
PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 (K023112)Problem Solving Concepts, Inc.2002-12-17
ARTHREX OPES ELECTRODES AND ACCESSORIES (K023986)Arthrex, Inc.2002-12-17
STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW (K023539)Valumed2002-12-17
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022288)Bayer Corp.2002-12-17
AMEDICA DRUG SCREEN METHAPHETAMINE TEST (K023101)Amedica Biotech, Inc.2002-12-16
AUTOLENS CLEANING AND DISINFECTING UNIT (K021699)Autolens, Inc.2002-12-16
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) (K023087)Howmedica Osteonics Corp.2002-12-16
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K023316)Lin-Zhi International, Inc.2002-12-16
AMEDICA DRUG SCREEN AMPHETAMINE TEST (K023104)Amedica Biotech, Inc.2002-12-16
ABBOTT ARCHITECT FOLATE (K023397)Abbott Laboratories2002-12-16
PREG-Q EARLY PREGNANCY TEST (K023027)Yd Diagnostics2002-12-16
SAS BLOOD/SERUM/URINE/URINE HCG (K022683)Sa Scientific, Inc.2002-12-16
AMEDICA DRUG SCREEN PHENCYCLIDINE TEST (K023109)Amedica Biotech, Inc.2002-12-16
GELSPHERES EMBOLIC AGENT (K023089)Biocure, Inc.2002-12-16
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) (K023361)Dade Behring, Inc.2002-12-16
TROJAN MINT TINGLE BRAND LATEX CONDOMS (K023405)Armkel, LLC2002-12-16
KERATOME BLADE 200200 & 600600 (K020482)Micro Specialties, Inc.2002-12-16
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 (K022762)Jomed, Inc.2002-12-16
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL (K023084)Medical Advances, Inc.2002-12-16
QUICKTOX MULTIPLE DRUG DIPCARD (K023489)Branan Medical Corp.2002-12-16
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) (K023081)Medical Bio Care Sweden AB2002-12-16
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 (K023938)Hutchinson Technology, Inc.2002-12-13
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 (K023500)Innovatech, Inc.2002-12-13
INFANT/CHILD REDUCED ENERGY ELECTRODES (K022732)Medtronic Physio-Control Corp.2002-12-13
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM (K023233)Ebi, L.P.2002-12-13
TUCKER EMBRYO CATHETER (K023017)Fertility Technology Resources, Inc.2002-12-13
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 (K023261)Taut, Inc.2002-12-13
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM (K023797)Medtronic Sofamor Danek2002-12-13
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D (K020899)Pneupac , Ltd.2002-12-13
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K022773)Barco N.V.2002-12-13
COLUMBUS (CR) TOTAL KNEE SYSTEM (K023788)Aesculap, Inc.2002-12-13
BIOLOY (K023477)Neirynck & Vogt NV2002-12-13
UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) (K023129)Unidus Corp.2002-12-13
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER (K022905)Horizon Medical Products, Inc.2002-12-13
COOPERSURGICAL TRIAL TRANSFER CATHETER (K023384)Cooper Surgical2002-12-13
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM (K023491)Help Technologies2002-12-13
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE (K023229)American Mammographics, Inc.2002-12-13
A1CNOW FOR HOME USE (K022661)Metrika, Inc.2002-12-13
ENHANCE HTF MEDIUM WITH HEPES (K023655)Conception Technologies2002-12-13
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER (K023383)Cooper Surgical2002-12-13
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K023243)Sulzer Intratherapeutics, Inc.2002-12-13
AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS (K023212)Ag Garments2002-12-13
UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) (K023175)Unidus Corp.2002-12-13
K-ASSAY LP(A) CONTROLS (K023853)Kamiya Biomedical Co.2002-12-13
APEX HRI DIGITAL RADIOGRAPHY SYSTEM (K023292)Krugman Technologies, Inc.2002-12-13
PARAGON INFUSION SYSTEM WITH BOLUS (K023827)I-Flow Corp.2002-12-13
SPERMGRAD, MODELS 10022/10063 (K023403)Vitrolife Sweden AB2002-12-13
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) (K023541)Dade Behring, Inc.2002-12-13
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM (K023415)Medtronic Sofamor Danek2002-12-13
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K023832)Lifescan, Inc.2002-12-13
SPERM WASH MEDIUM WITH GENTAMICIN (K023717)Conception Technologies2002-12-13
UNDUS MALE LATEX CONDOM (WITH FLAVORING) (K023176)Unidus Corp.2002-12-13
TULIP ALGINATE IMPRESSION MATERIAL (K023466)Cavex Holland BV2002-12-13
HA ORBITAL IMPLANT (K021643)Laboratoire Villanova2002-12-13
COMPREHENSIVE HUMERAL FRACTURE SYSTEM (K023063)Biomet Orthopedics, Inc.2002-12-13
MILLENNIUM SERIES MANUAL WHEELCHAIRS (K024030)Evermed Corp.2002-12-12
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Every clearance here is in the API, with alerts when new ones post.