Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P (K121399)Luminex Corp.2013-01-09
TRANSTEK GLASS BODY FAT ANALYZER (K123781)Zhongshan Transtek Electronics Co., Ltd.2013-01-09
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE (K122914)Medtronic, Inc.2013-01-09
LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123798)Bio-Rad Laboratories2013-01-09
MERITS MODEL P322FWD POWERED WHEELCHAIR (K122357)Merits Health Products Co., Ltd.2013-01-09
BEST LOCALIZATION NEEDLE WITH I-125 SEED (K122704)Best Medical Intl.2013-01-09
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM (K122336)Eleven Blade Solutions, Inc.2013-01-09
STRYKER CROSSFLOW ARTHROSCOPY PUMP (K123441)Stryker Endoscopy2013-01-09
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (K122062)Gen-Probe, Inc.2013-01-09
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS (K123863)Ucp Biosciences, Inc.2013-01-09
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE (K123213)Becton, Dickinson & CO2013-01-09
ASAP MUITISCOPE (K121261)Asap Endoscopic Products GmbH2013-01-08
AEQUALIS ASCEND FLEX SHOULDER SYSTEM (K122698)Tornier S.A.S.2013-01-08
MEGA 5.5 SPINE SYSTEM (K123476)Lsk Biopartners, Inc.2013-01-08
MALLEABLE TIP ENDOSCOPIC APPLICATOR (K123847)Micromedics, Inc.2013-01-08
COLLAGEN TENDON SHEET-D (K122048)Rotation Medical, Inc.2013-01-08
FALCON SPACER (K123180)Synthes (USA) Products, LLC2013-01-08
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET (K123868)Baxter Healthcare Corp2013-01-08
ALIGNRT PLUS (K123371)Vision RT Limited2013-01-08
SOLOCEM (K121621)Coltene/Whaledent AG2013-01-08
VANTAGE MODEL V5000, V5100, V5000C, V5100C (K122643)Midmark Corp.2013-01-07
ENTEROCOCCUS QUICKFISH BC (K121991)Advandx, Inc.2013-01-07
BRAINSWAY DEEP TMS SYSTEM (K122288)Brainsway , Ltd.2013-01-07
TS IMPLANT SYSTEM (K121585)Osstem Implant Co., Ltd.2013-01-07
AVIE TOTAL HB TEST SYSTEM (K121752)Mec Dynamics Corp2013-01-07
THERASOM-CAST (K113516)Family Dental Services, P.C.2013-01-04
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER (K122854)Arrow International (Subsidiary of Teleflex Inc.)2013-01-04
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY (K123731)Glaxosmithkline Consumer Healthcare (Gskch)2013-01-04
INSTINCT JAVA SYSTEM (K122592)Zimmer Spine2013-01-04
K7C SPACER (K123388)K7, LLC2013-01-04
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K113787)Defibtech, LLC2013-01-04
OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE (K122818)Olympus Keymed (Medical & Industrial Equipment) LT2013-01-04
BODY FAT SCALE MODEL SF-371 (K122976)Shenzhen Belter Health Measurement and Analysis TE2013-01-04
JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 (K123194)North American Rescue Products, Inc.2013-01-03
PEARL DIABETES MANAGEMENT SYSTEM (K122483)Asante Solutions, Inc.2013-01-03
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (K122943)Moor Instruments, Ltd.2013-01-03
NEO ERCP GUIDEWIRE (K123439)Neometrics, Inc.2013-01-03
CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K123759)Arrow International, Inc. (Subsidiary of Teleflex2013-01-03
SUPER STAPLE(TM) CLASSIC (K123363)Metric Medical Devices, Inc.2013-01-03
COLLADENTAL BARRIER (K100695)Collamatrix, Inc.2013-01-03
RETRACTA DETACHABLE EMBOLIZATION COIL (K123712)Cook Incorporated2013-01-03
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER (K121975)Fisher & Paykel Healthcare, Ltd.2013-01-03
BIOPHOTAS LIFELIGHT (K122237)Biophotas, Inc.2013-01-03
TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM (K123452)Stryker2013-01-03
DOPPLEX ABILITY (K121108)Huntleigh Healthcare2013-01-03
SOVEREIGN MINI (K123102)Aesculap, Inc.2013-01-03
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS (K122457)GE Healthcare2013-01-02
INTERVENTIONAL WORKSPOT (K121296)Philips Medical Systems Nederland B.V.2013-01-02
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K123877)Surgical Specialties Corp. Dba Angiotech2013-01-02
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS (K122273)Menicon Co, Ltd.2013-01-02
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT (K121944)DiaSorin, Inc.2013-01-01
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA (K122919)Rayence Co., Ltd.2013-01-01
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Every clearance here is in the API, with alerts when new ones post.