Atlas FDA

2013

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

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RecordFirmDate
PATIENT MONITOR (K130056)Ld Technology, LLC2013-04-11
EXTREMITY MEDICAL IP FUSION SYSTEM (K130120)Extremity Medical, LLC2013-04-11
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (K122812)Wuxi Jiajian Medical Instrument Co., Ltd.2013-04-11
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K123700)Cas Medical Systems, Inc.2013-04-11
INCITE ANCHORED CERVICAL INTERBODY DEVICE (K130306)Incite Innovation, LLC2013-04-11
ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 (K122996)Xhale2013-04-10
STRAUMANN DENTAL IMPLANT SYSTEM (K123784)Straumann USA, LLC2013-04-10
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) (K123703)Healgen Scientific,, LLC2013-04-10
JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM (K130637)Medrad, Inc.2013-04-10
CD HORIZON SPINAL SYSTEM (K130646)Medtronic Sofamor Danek USA, Inc.2013-04-10
PENTAX EPK-I5010 VIDEO PROCESSOR (K122470)Pentax Medical2013-04-10
SPINE COIL (K123708)Usa Paramed Medical Systems, Inc.2013-04-10
GORE ACUSEAL VASCULAR GRAFT (K130215)W. L. Gore & Associates, Inc.2013-04-09
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL (K130665)Guangzhou Wondfo Biotech Co., Ltd.2013-04-09
WARMING JELLY PERSONAL LUBRICANT (K123770)Wisconsin Pharmacal Co., LLC2013-04-09
DEVON CIRONA 6100 DVT (K130571)Devon Medical, Inc.2013-04-09
CLEARFIL MAJESTY ES FLOW (K130371)Kuraray Noritake Dental, Inc.2013-04-09
EUROIMMUN ANTI-ENA POOL ELISA (IGG) (K112996)Euroimmun US2013-04-09
PSA SERIES (K123916)Osypka Medical, Inc.2013-04-09
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT (K123153)Medtronic, Ireland2013-04-09
CAPSTONE L SPINAL SYSTEM (K123978)Medtronic Sofamor Danek USA2013-04-09
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM (K122112)Bio Compression Systems, Inc.2013-04-09
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF (K123996)Ge Medical Systems Information Technologies, Inc.2013-04-09
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM (K123786)Stryker2013-04-09
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321)Diasorin2013-04-09
SYNAPSE 3D CARDIAC TOOLS (K130383)Fujifilm Medical System U.S.A., Inc.2013-04-09
INCORIS ZI (K123664)Sirona Dental Systems GmbH2013-04-08
XP200 (K122966)Btl Industries, Ltd.2013-04-08
OTOMAG BONE CONDUCTION HEARING SYSTEM (K123962)Sophono, Inc.2013-04-08
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 (K130469)DiaSorin, Inc.2013-04-05
MONSTER SCREW SYSTEM (K124027)Apogee Orthosolutions2013-04-05
FIBROSCAN (K123806)Echosens2013-04-05
HEARLAB ACA (K123701)Frye Electronics, Inc.2013-04-05
HEALTHY SLEEP APPLIANCE (K123410)Healthy Sleep Dental Laboratory2013-04-05
6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM (K122198)Oco Biomedical2013-04-05
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS (K130006)Cook Biotech Incorporated2013-04-05
ISOLATOR LINEAR PEN (K130521)AtriCure, Inc.2013-04-05
ARTHREX FRACTURE PLATES (K123241)Arthrex, Inc.2013-04-05
OLYMPUS ENERGY POWER SYSTEM (EPS) (K123429)Gyrus Acmi, Inc.2013-04-05
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) (K130698)Siemens Healthcare Diagnostics2013-04-05
ACCUMESH DEPLOYMENT SYSTEM (K130782)Covidien, LLC2013-04-05
NEURO OMEGA SYSTEM (K123796)Alpha Omega Engineering , Ltd.2013-04-05
PONTIC PAINT (K130237)Reliance Orthodontic Products, Inc.2013-04-05
MERIT HYDROPHILIC GUIDE WIRE (K130588)Merit Medical Systems, Inc.2013-04-05
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM (K130308)Hitachi Aloka Medical, Ltd.2013-04-05
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP (K121478)Mapa GmbH2013-04-05
CIQ CONTROLLER, CIQ WANDS (K123353)ArthroCare Corporation2013-04-05
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM (K122307)Biocare Corporation2013-04-05
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 (K123089)Abbott Laboratories2013-04-05
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER (K130744)Covidien2013-04-05
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY (K122453)Industrial Clothings, Ltd.2013-04-05
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 (K130069)GE Healthcare2013-04-05
SENTREX BIOSPONGE MPD (K123961)Bionova Medical, Inc.2013-04-05
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM (K122049)Kinamed, Inc.2013-04-05
MERETEC CS, CORTICAL SCREWS (K130400)Merete Medical GmbH2013-04-05
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) (K123122)Cleveland Clinic2013-04-05
SIMPLI SIMPLER IMPLANT SYSTEM (K121281)Simpler Implant Solutions2013-04-05
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM (K130044)Wrightmedicaltechnologyinc2013-04-05
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY (K123243)Orthocon, Inc.2013-04-05
LOCKING BONE PLATES AND SCREWS (K130340)Weigao Orthopaedic Device Co., Ltd.2013-04-05
MEPILEX TRANSFER AG (K123892)Molnlycke Health Care2013-04-05
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE (K122194)Everyway Medical Instruments Co.,Ltd2013-04-04
KCI NPWT GAUZE DRESSING (K123507)Kci USA, Inc.2013-04-04
HYSTEROSCOPY PUMP HM6 (K123732)W.O.M. World of Medicine AG2013-04-04
IMMULITE 2000 ANTI-CCP IGG ASSAY (K121576)Siemens Healthcare Diagnostics, Inc.2013-04-04
AGILITY (K123808)Elekta , Ltd.2013-04-04
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II (K130765)Elitechgroup2013-04-04
PHANTOM FIBER BIOFIBER SUTURE (K130422)Tornier, Inc.2013-04-04
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (K122688)Nova Biomedical Corporation2013-04-04
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS (K123263)Eckert & Ziegler Bebig GmbH2013-04-04
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 (K121951)DiaSorin, Inc.2013-04-04
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK (K123829)Portable Therapeutix, LLC2013-04-03
STRYKER IVAS BALLOON CATHETER (K123942)Stryker Corporation2013-04-03
SPEQRT ULTRASOUND SYSTEM (K130659)Signostics Pty, Ltd.2013-04-03
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR (K130023)Np Medical, Inc.2013-04-03
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS (K130285)The Lagado Corp.2013-04-03
ACCULIF XL CAGE (K130194)Coalign Innovations, Inc.2013-04-03
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (K130423)Richard Wolf Medical Instruments Corp.2013-04-03
INTUITION (K121916)Terarecon,Inc.2013-04-02
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT (K130470)Geneohm Sciences Canada, Inc. (Bd Diagnostics)2013-04-02
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS (K130576)B. Braun Interventional Systems, Inc.2013-04-02
THERMOFINDER; THERMOCARE (K130361)Hubdic Co., Ltd.2013-04-02
TANDA MINI SKINCARE SYSTEM (K124042)Syneron Beauty2013-04-02
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER (K123943)Ameco Medical Industries2013-04-02
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS (K123820)Bossong Hosiery Mills, Inc.2013-04-02
SYNGO.CT NEURO PERFUSION (K123541)Siemens Medical Systems, Inc.2013-04-02
INMODE SR IPL DEVICE (K123860)Inmode MD , Ltd.2013-04-02
EXCELSIOR (K130453)Eyekor, LLC2013-04-02
INFINITY TOTAL ANKLE SYSTEM (K123954)Wrightmedicaltechnologyinc2013-04-01
NEUROBLATE SYSTEM (K120561)Monteris Medical, Inc.2013-04-01
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM (K123906)Medtronic Sofamor Danek USA, Inc.2013-04-01
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER (K120056)The Binding Site Group , Ltd.2013-04-01
TRANS1LATERAL INTERBODY FUSION SYSTEM (K123997)Trans1, Inc.2013-04-01
IFUSE IMPLANT SYSTEM (K123850)SI-BONE, Inc.2013-04-01
WALKAIDE SYSTEM (K123972)Innovative Neurotronics, Inc.2013-04-01
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE (K130402)Sintea Plustek, LLC2013-04-01
STREAMLINE MIS SPINAL FIXATION SYSTEM (K130286)Pioneer Surgical Technology, Inc.2013-04-01
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM (K123733)Medtronic, Inc.2013-04-01
NMI COAXIAL MICROINTRODUCER SET (K123445)Navilyst Medical, Inc.2013-04-01
D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION (K130497)Linvatec Corporation D/B/A Conmed Linvatec2013-03-29
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Every clearance here is in the API, with alerts when new ones post.