Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COMPACT TOUCH (K094038)Quantel S.A.2010-04-22
INSTAFLO BOWEL CATHETER SYSTEM KIT (K100273)Hollister, Inc.2010-04-22
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 (K100334)B. Braun Avitum AG2010-04-22
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING (K093974)Osmetech Molecular Diagnostics2010-04-22
MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM (K094045)Cardo Medical Corp.2010-04-22
TORNIER SURGICAL MESH (K093799)Tornier, Inc.2010-04-22
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526)Kentec Medical, Inc.2010-04-22
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM (K100415)Lumenis2010-04-21
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST (K100789)Evalve, Inc.2010-04-21
SMITH & NEPHEW HIP SYSTEMS WITH HA (K090982)Smith & Nephew, Inc.2010-04-21
GTX 12 GIDEWIRE (K100470)Medtronic, Inc.2010-04-21
ACUPUNCTURE NEEDLES (K092240)Haenglim Seowon Medical Co.2010-04-21
VENTRIO HERNIA PATCH (K100229)C.R. Bard, Inc.2010-04-21
NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X (K100195)Nds Surgical Imaging2010-04-21
VITAPHONE. MODEL 100 BT (K100383)Vitasystems GmbH2010-04-20
CLEARWAY OTW MODEL 85912 (K093431)Atrium Medical Corp.2010-04-20
IMC SURGICAL DRAPE (K100208)International Medsurg Connection2010-04-20
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY (K100618)Orthohelix Surgical Designs, Inc.2010-04-20
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM (K100155)Biomedical Systems Corp.2010-04-20
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM (K100312)Dgimed Ortho, Inc.2010-04-20
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (K092048)Biosite Incorporated2010-04-19
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR (K100159)Smith & Nephew Inc., Endoscopy Div.2010-04-19
AMBU ASCOPE AND MONITOR (K093186)Ambu A/S2010-04-16
AMERICAN DENTAL PRODUCTS SE BONDEASY (K093014)American Dental Products, Inc.2010-04-16
AIRWAYEASE MAS (K090436)Orthoplant Dental Lab2010-04-16
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES (K094018)Biocompatibles UK Limited2010-04-16
GDS-DC12 (K100135)Guided Delivery Systems2010-04-16
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT (K100173)Sainath Intellectual Properties, LLC2010-04-16
ELI 230 ELECTROCARDIOGRAPH (K100127)Mortara Instrument, Inc.2010-04-16
VAPOR-CLEAR, MODEL 100 (K092031)Axon Medical, Inc.2010-04-16
ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT (K093780)Astra Tech, Inc.2010-04-16
SORING MBC200/BCC140 (K093511)Soring GmbH Medizintechnik2010-04-16
PEANUT GROWTH CONTROL PLATING SYSTEM (K093880)Ebi, L.P.2010-04-16
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 (K100241)B.Braun Medical, Inc.2010-04-16
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 (K100663)Boston Scientific Corporation2010-04-16
BD PEN NEEDLE (K100005)Becton, Dickinson and Co.2010-04-15
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS (K093991)Smith & Nephew, Inc.2010-04-15
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM (K100745)Hoana Medical, Inc.2010-04-15
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT (K092472)Ascend Eagle, Inc.2010-04-15
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (K100191)Lanx, Inc.2010-04-15
CLARO (K090744)Clrs Technology Corporation2010-04-15
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; (K093611)Ortho-Clinical Diagnostics, Inc.2010-04-15
INOMAX DS (K093922)Ino Therapeutics2010-04-15
CORMET CEMENTLESS RESURFACING FEMORAL HEAD (K092198)Corin USA2010-04-15
ELECSYS TSH CALCHECK 5 (K093836)Roche Diagnostics2010-04-15
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A (K100394)Shanghai 3f Electronics Co, Ltd.2010-04-15
LASERTOUCHONE (OTC) (K100116)Laser Health Technologies, LLC2010-04-15
INTELLIVUE CLINICAL INFORMATION PORTFOLIO (K100272)Philips Medical Systems2010-04-14
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM (K093746)Smith & Nephew, Inc.2010-04-14
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (K093904)Glenveigh Surgical, LLC2010-04-14
HYBERNITE RAINOUT CONTROL SYSTEM (K100104)Plastiflex Group NV2010-04-14
SYNAPSE OBLIQUUS MIP/MPR/FUSION (K100881)Fujifilm Medical System U.S.A., Inc.2010-04-14
CONTREX PLUS LOW CONTROL SOLUTION (K100747)Apex BioTechnology Corp.2010-04-14
BINAXNOW PBP2A TEST, MODEL 890-000 (K090301)Binax, Inc.2010-04-14
SYNTHES AIR PEN DRIVE (APD) SYSTEM (K093361)Synthes (Usa)2010-04-14
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE (K093907)Welch Allyn, Inc.2010-04-14
AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA (K100108)Amedica Biotech, Inc.2010-04-14
CAMBRIDGE HEART OEM (K100362)Cambridge Heart, Inc.2010-04-14
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100392)Tangshan Jiaxing Plastic Products Co., LT2010-04-13
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE (K093695)Peak Surgical, Inc.2010-04-13
VASHE WOUND THERAPY SOLUTION (K093697)Puricore, Inc.2010-04-13
RETROFLEX DILATOR KIT (K093554)Edwards Lifesciences, LLC2010-04-13
ZUMA-C (K092521)Seaspine, Inc.2010-04-13
A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 (K100145)A&E Bioceramic Co., Ltd.2010-04-13
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX (K100892)Boston Scientific Corp2010-04-12
ENTEROSCOPY OVERTUBE, MODEL 00712140 (K100081)United States Endoscopy Group, Inc.2010-04-12
MULTI FRAME WHEELCHAIR (K100084)R82 A/S2010-04-12
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM (K100737)Stryker Spine2010-04-12
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT (K091022)STERIS Corporation2010-04-12
DEROYAL NON-LOCKING BONE FIXATION SYSTEM (K090975)Deroyal Industries, Inc.2010-04-12
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM (K100111)Zimmer, Inc.2010-04-12
PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE (K092066)Andrew Technologies, LLC2010-04-12
FIBERLASE C02 LASER WAVEGUIDE (K100384)Lumenis, Ltd.2010-04-12
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 (K100264)Bionix Development Corp.2010-04-09
SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM (K091720)Sklar Corp.2010-04-09
PEAK EXPIRATORY FLOW METER, KN-9710 (K092335)K-Jump Health Co., Ltd.2010-04-09
NEUROLINK IP MODEL: PK1117 (K100683)Natus Medical Incorporated2010-04-09
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH (K093932)Ethicon GmbH2010-04-09
LIQUIBAND ULTIMA, LUT 003 (K100284)Medlogic Global Limited2010-04-09
MASTER-VU A-SCAN, MV4500 (K100252)Sonomed, Inc.2010-04-09
ULTRAVIEW DM3 MONITOR (K093802)Zoe Medical, Inc.2010-04-09
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL (K100676)Synthes (Usa)2010-04-08
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 (K100701)Biotest Medical Corp.2010-04-08
XCERAM (K100250)Xceramusa2010-04-08
DIAZYME CYSTATIN C ASSAY (K093680)Diazyme Laboratories2010-04-08
POWDER-FREE VINYL EXAM GLOVES (K091772)Shijiazhuang Huijingyuan Plastic Co, Ltd.2010-04-08
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C (K093394)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-04-08
MYKNEE CUTTING BLOCKS (K093806)Medacta International S.A.2010-04-08
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION (K093288)Cardionet, Inc.2010-04-08
CATHETER CONNECTIONS DUALCAP (K093229)Catheter Connections, Inc.2010-04-08
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS (K092351)Polyremedy, Inc.2010-04-08
UNICEM (K094007)3M Espe AG Dental Products2010-04-08
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS (K092348)Polyremedy, Inc.2010-04-08
XKNIFE 5 (K100417)Integra Radionics, Inc.2010-04-08
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 (K100046)Guangdong Biolight Meditech Co., Ltd.2010-04-08
ORS VISUAL (K100335)Object Research Systems, Inc.2010-04-08
APEX ARC HIP STEM (K090845)Omni Life Science, Inc.2010-04-07
ALPHA ORTHOPAEDICS AT3 SYSTEM (K094041)Alpha Orthopaedics2010-04-07
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (K093441)Siemens Healthcare Diagnostics2010-04-07
NAVIX ACCESS DEVICE (K093279)Xlumena2010-04-07
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Every clearance here is in the API, with alerts when new ones post.