Atlas FDA

2013

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

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RecordFirmDate
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD (K123738)Nidek Medical Products, Inc.2013-02-28
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS (K120592)Dana Products, Inc.2013-02-27
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 (K130197)Becton, Dickinson and Company2013-02-27
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS (K123501)Biomet, Inc.2013-02-27
VITAL 5 RELEAF CATHETER (K122661)Vital 52013-02-27
INMODE HAIR REMOVAL (HR) DEVICE (K123682)Inmode MD , Ltd.2013-02-27
XOFT AXXENT CERVICAL APPLICATORS (K123442)Icad, Inc.2013-02-27
DIGITAL ELECTROCARDIOGRAPHS (K123816)Shenzhen Biocare Electronics Co., Ltd.2013-02-27
VITAL SYNC SYSTEM (K123002)Covidien, Formerly Nellcor Puritan Bennett, Inc.2013-02-27
PICCOLO COMPOSITE PLATE SYSTEM (K130061)CarboFix Orthopedics , Ltd.2013-02-27
BIODESIGN ENT REPAIR GRAFT (K121360)Cook Biotech Incorprated2013-02-27
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM (K123361)Fiab Spa2013-02-27
QUATTRO AIR (K123979)Resmed, Ltd.2013-02-27
SIMMETRY SACROILIAC JOINT FUSION SYSTEM (K130092)Zyga Technology, Inc.2013-02-27
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR (K130196)Arthrocare Corp.2013-02-27
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) (K123672)Inion OY2013-02-27
OSTAVI HYDROPHILIC GUIDEWIRE (K124052)Lake Region Medical2013-02-26
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM (K123529)Siemens Medical Solutions USA, Inc.2013-02-26
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (K120817)Inova Diagnostics, Inc.2013-02-26
ORTHOCORD (K123668)Depuy Mitek, Inc., A Johnson and Johnson Company2013-02-26
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (K123433)Cedars-Sinai Medical Center2013-02-26
BRIDGE EXTRACELLULAR COLLEGEN MATRIX (K122502)Harbor Medtech, Inc.2013-02-26
HEINE OMEGA 500 (K123316)Heine Optotechnik GmbH & Co. KG2013-02-26
ACHILLES (K123238)Ge Medical Systems China Co., Ltd.2013-02-25
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (K123549)Biomet Spine (Aka Ebi, LLC)2013-02-25
THE ARTAS SYSTEM (K123548)Restoration Robotics, Inc.2013-02-25
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K123656)Medtronic Sofamor Danek USA, Inc.2013-02-25
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING (K122578)Vital Images, Inc.2013-02-25
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE (K122015)Howmedica Osteonics Corp.2013-02-22
VPULSE (K122640)Cothera, LLC2013-02-22
MYVISIONTRACK(TM) (K121738)Vital Art and Science Incorporated2013-02-22
INCLUSIVE TAPERED IMPLANT SYSTEM (K121406)Prismatik Dentalcraft, Inc.2013-02-22
LIFESTYLES WARM LOVIN PERSONAL LUBRICANT (K122720)Ansell Healthcare Products, LLC2013-02-22
MAMMOMAL INSPIRATION (K122286)Siemens Medical Solutions USA, Inc.2013-02-22
MRI PATIENT MONITORING SYSTEM (MODEL 865214) (K124061)Invivo Corporation2013-02-22
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA (K123187)Edwards Lifesciences, LLC2013-02-22
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL (K123681)Wipro GE Healthcare Private, Ltd.2013-02-22
ZI BLOWER (K121374)Deshum Medical2013-02-22
PERSONA NATURAL TIBIA BASEPLATES (K130143)Zimmer, Inc.2013-02-22
OPTOS OCT/SLO MICROPERIMETER (K121043)Optos Plc.2013-02-22
IRIS - HIGH STRENGTH GLASS CERAMIC (K123615)Dentsply Intl.2013-02-22
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM (K123459)Zimmer, Inc.2013-02-22
EOS (K123740)Eos Imaging2013-02-22
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (K121795)Cytophil, Inc.2013-02-22
T:CONNECT DATA MANAGEMENT SYSTEM (K122361)Tandem Diabetes Care, Inc.2013-02-22
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE (K122727)Northstar Healthcare Holdings2013-02-22
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 (K130058)Olympus Medical Systems Corp.2013-02-22
U-MOTION II ACETABULAR SYSTEM (K122185)United Orthopedic Corp.2013-02-22
EMORY CARDIAC TOOLBOX 4.0 (K123646)Syntermed, Inc.2013-02-22
CD HORIZON SPINAL SYSTEM (K123809)Medtronic Sofamor Danek USA, Inc.2013-02-22
SILKN BLUE (K121435)Home Skinovations , Ltd.2013-02-22
VITRO FIL LC (K123824)Dfl Industria E Comercio SA2013-02-21
COMFORT COUGH (K113549)Seoil Pacific Corp.2013-02-21
VERIFICATION CONSOLE (K124002)Varian Medical Systems2013-02-21
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE (K130038)Hl Rubber Industries Sdn Bhd2013-02-21
PERCUTANEOUS INTRODUCER KIT (K123974)Teleflex, Inc.2013-02-21
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL (K123994)Ciba Vision Corporation2013-02-21
PEKKTON IVORY (K123638)Cendres & Metaux SA2013-02-21
COPRANCOLOR (K123680)White Peaks Dental Systems GmbH & Co. KG2013-02-21
EMBLETTA MPR (K122516)Embla Systems2013-02-21
CINCHLOCK KNOTLESS SUTURE ANCHOR (K123651)Pivot Medical2013-02-21
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (K123337)Caldera Medical2013-02-21
FIBER DISK AND BLOCK PERMANENT, TRINIA (K121735)Bioloren S.R.L.2013-02-21
LUCENT (K122967)Spinal Elements, Inc.2013-02-21
FIN-S MICROIMPLANT (K120861)Creekside Orthodontics2013-02-21
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (K124060)Medicalgorithmics S.A.2013-02-21
DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 (K123175)Conmed Corporation2013-02-21
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL (K123425)Smith & Nephew, Inc.2013-02-20
SYNSPAR ADVANCED (K123613)Ardent, Inc.2013-02-20
ARIX RAD ACQUISITION CONSOLE (K123650)Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.2013-02-20
MDU5 PLUS STERILE BAG (K123424)Boston Scientific Corp2013-02-20
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT (K122477)Ansell Healthcare Products, LLC2013-02-19
NEXUS RMGI (K123595)Kerr Corporation2013-02-19
COMMUNIFY PACS VIEWER (K120851)Communify Health, LLC2013-02-19
ARTAS SYSTEM FROM RESTORATION ROBOTICS (K123154)Restoration Robotics, Inc.2013-02-19
DESARA SL (K121928)Caldera Medical, Inc.2013-02-19
INTRADERMAL ADAPTER (K123588)West Pharmaceutical Services, Inc.2013-02-19
MAMMOWORKSTATION (K123575)Image Diagnost International GmbH2013-02-19
REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 (K110941)Allmed Systems, Inc.2013-02-19
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE (K123469)Wear Safe (Malaysia) Sdn Bhd - Facility II2013-02-19
GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC (K122894)Geistlich Pharma AG2013-02-15
GRIDLOCK PLATING SYSTEM (K123525)Trilliant Surgical, Ltd.2013-02-15
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE (K122518)Bm Korea Co., Ltd.2013-02-15
CPI RAD VISION (K122726)Communications & Power Industries Canada, Inc.2013-02-15
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL (K122177)Elitechgroup2013-02-15
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC (K122315)Oculus Private Limited2013-02-15
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND (K122710)Shenzhen Delicate Electronics Co., Ltd.2013-02-15
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (K130200)Abaxis, Inc.2013-02-15
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS (K121608)Ortho-Clinical Diagnostics, Inc.2013-02-15
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (K123320)Siemens Healthcare Diagnostics2013-02-15
DIMENSION CHEMISTRY III CALIBRATORY (K123321)Siemens Healthcare Diagnostics2013-02-15
2008 HEMODIALYSIS SORBENT SYSTEM (K123835)Renal Solutions, Inc.2013-02-15
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (K123164)Spinefrontier, Inc.2013-02-15
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (K123851)Bionostics, Inc.2013-02-14
A200 KNEE SYSTEM (K120038)Renovis Surgical Technologies, LLC2013-02-14
LIFESTYLES NATURAL PERSONAL LUBRICANT (K122054)Ansell Healthcare Products, LLC2013-02-14
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES (K120675)Grandway Technology (Shenzhen) Limited2013-02-14
ILLICO MIS POSTERIOR FIXATION SYSTEM (K123623)Alphatec Spine, Inc.2013-02-14
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM (K120181)Huizhou Foryou Medical Devices Co., Ltd.2013-02-14
A5 ANESTHESIA DELIVERY SYSTEM (K123211)Datascope Corp., Patient Monitoring Division2013-02-14
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Every clearance here is in the API, with alerts when new ones post.