Atlas FDA

2014

3,202 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW (K141452)Jeil Medical Corporation2014-07-02
SPHYGMOMANOMETER (K141392)Suzhou JJ Meter Co., Ltd.2014-07-02
AVREO INTERWORKS SYSTEM (K141556)Avreo, Inc.2014-07-02
AP EXPANDABLE XLIF SYSTEM (K140162)Nuvasive, Inc.2014-07-02
SKYHAWK LATERAL PLATE SYSTEM (K140260)Orthofix, Inc.2014-07-02
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM (K141369)Philips Ultrasound, Inc.2014-07-02
FLOW-NAIL (K140601)Flow-Fx, LLC2014-07-02
ISOSEED (K140849)Eckert & Ziegler Bebig GmbH2014-07-02
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM (K140685)Sybron Endo2014-07-02
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM (K133861)Ostial Corporation2014-07-02
ODISSEY TISSUE OXIMETER (K141234)Vioptix, Inc.2014-07-01
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS (K141406)Immunalysis Corporation2014-07-01
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET (K141148)Cook Vascular, Inc.2014-07-01
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS (K140400)Stryker Corporation2014-07-01
ALTERA SPACER (K140411)Globus Medical, Inc.2014-07-01
DRE VENTURA (K132903)Dre Medical, Inc.2014-07-01
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS (K133693)Canon, Inc.2014-07-01
DESARA BLUE OV, DESARA BLUE SS (K140843)Caldera Medical2014-07-01
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 (K133916)Biosense Webster, Inc.2014-07-01
CASPIAN OCT SPINAL SYSTEM (K133288)K2m, Inc.2014-07-01
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) (K132036)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014-07-01
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (K141458)Focus Diagnostics2014-07-01
MEGA BIG BOY CONDOM (K140379)Okamoto USA, Inc.2014-07-01
EXACTECH TAPERED WEDGE FEMORAL STEM (K140674)Exactech, Inc.2014-06-30
DELTA TT ACETABULAR SYSTEM (K141395)Lima Corporate S.P.A.2014-06-30
MUELLER HINTON AGAR (K132491)Edge Biologicals, Inc.2014-06-30
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K140751)Intromedic Co., Ltd.2014-06-30
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM (K140833)Conformis, Inc.2014-06-30
BICARBONATE CALIBRATOR (K141374)Beckman Coulter Ireland, Inc.2014-06-30
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM (K124021)Arkray Factory, Inc.2014-06-30
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE (K132354)Advanced Health Products, Lot 60 & 612014-06-30
DUAL SHOT ALPHA 7 (K133189)Nemoto Kyorindo Co., Ltd.2014-06-30
MBD PLATE SYSTEM (K141045)Mbd Medical, LLC2014-06-30
SHUNTONG (K140243)Shuntong Glove Co., Ltd.2014-06-30
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM (K133575)Spinevision S.A.2014-06-30
ZF 720 (K132551)Umbel Corporation2014-06-30
PRECICE TRAUMA NAIL SYSTEM (K141447)Ellipse Technologies, Inc.2014-06-30
HICUT HIGHSPEED INSTRUMENT (K130755)Adeor Medical AG2014-06-27
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER (K140542)Rhinosystems, Inc.2014-06-27
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM (K133260)Tianjin Empecs Medical Device Co., Ltd.2014-06-27
CRC PC WITH SMART CHAMBER (K141413)Capintec, Inc.2014-06-27
SURGICAL NAVIGATION ADVANCED PLATFORM (K140819)Surgical Theater, LLC2014-06-27
EUROIMMUN ANTI-PLA2R ELISA (IGG) (K132195)Euroimmun Us, Inc.2014-06-27
P-STIM (K140788)Biegler GmbH2014-06-27
PERICAN ULTRA (K133632)B.Braun Medical, Inc.2014-06-27
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG (K140701)Novosource, Inc.2014-06-27
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER (K140823)Varian Medical Systems, Inc.2014-06-27
BIODENTINE (K140132)Septodont2014-06-27
DEVON CIRONA 6200 DVT (K141578)Devon Medical2014-06-27
HIVOX ELECTRIC STIMULATOR OTC TENS (K140650)Hivox Biotek, Inc.2014-06-27
PARI-PATH SURGICAL NAVIGATION SYSTEM (K133901)Paritic, Inc.2014-06-27
MDMC-12133 (K141428)Barco N.V.2014-06-27
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (K140289)Summit Medical, Inc.2014-06-27
A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR (K141179)A & D Co., Ltd.2014-06-27
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER (K133843)Cordis Corporation2014-06-27
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD (K141454)Sony Electronics, Inc.2014-06-26
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (K141346)Sony Electronics, Inc.2014-06-26
REWALK (DEN130034)Argo Medical Technologies, Inc.2014-06-26
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K141002)Visionsense, Ltd.2014-06-26
KANGLI PEDICLE SCREW SPINAL SYSTEM (K140053)Suzhou Kangli Orthopaedics Instrument Co., Ltd.2014-06-26
CONSURE STOOL MANAGEMENT SYSTEM (K133465)Consure Medical Pvt , Ltd.2014-06-26
DIAMOND RATTLESNAKE SYSTEM (K133194)Eminent Spine2014-06-26
SURESIGNS VS3, SURESIGNS VS4 (K133961)Philips Medical Systems2014-06-26
LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM (K140803)Nucletron B.V.2014-06-26
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS (K133579)Pontis Orthopaedics, LLC2014-06-26
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (K140588)Stryker Corporation2014-06-26
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS (K141376)Nexxt Spine, LLC2014-06-26
COROENT THORACOLUMBAR IMPLANTS (K140659)Nu Vasive, Incorporated2014-06-26
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM (K141397)Precision Spine, Inc.2014-06-26
MEDLEY GOLD (K140435)American Dental Sleep Medicine, Ip, LLC2014-06-26
MASIMO ROOT MONITORING SYSTEM (K140188)Masimo Corporation2014-06-25
OPTIMUS FUSION: SLT, YAG AND YAG/SLT (K140336)Quantel Medical2014-06-25
BONDILOXS TOPICAL HEMOSTATIC DRESSING (K132333)Medtrade Products , Ltd.2014-06-25
VENUS SWAN(MP)2 (K140629)Venus Concept , Ltd.2014-06-25
TRUKLEAR BRACKET (K141104)Ajw Technology Consultants, Inc.2014-06-25
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM (K132180)Ideal Life, Inc.2014-06-25
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM (K140801)Bio-Rad Laboratories, Inc.2014-06-25
ABSOLUTE DENTIN 2 (K132115)Parkell, Inc.2014-06-25
SATURNO(TM) OVERDENTURE IMPLANT SYSTEM (K133327)Zest Anchors, LLC2014-06-25
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK (K133848)Heartvista, Inc.2014-06-25
BREEZE NEBULIZER (NBR-10X) (K133105)Digio2 International Co., Ltd.2014-06-24
MOBIUS3D (K140660)Mobius Medical Systems, LP2014-06-24
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL (K133816)Siemens Healthcare Diagnostics, Inc.2014-06-24
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET (K133083)Diazyme Laboratories2014-06-24
APTUS ULNA SHORTENING 2.5 (K141232)Medartis AG2014-06-23
CONTOUR NEXT EZ BLOOD GLUCOSE METER (K130265)Bayer Healthcare, LLC2014-06-23
LIQUICHEK TUMOR MARKER CONTROL (K141073)Bio-Rad Laboratories2014-06-23
SUPOLENE (K141072)Resorba Medical GmbH2014-06-23
NOVOPRESS (K131416)Milka, LLC2014-06-23
CLIQ DV-300 ASPIRATOR (K140809)Ding Hwa Co., Ltd.2014-06-23
RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K133193)Riverstone Resources Sdn Bhd2014-06-23
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, (K140711)Paragon Bioteck, Inc.2014-06-20
DISCOVERY SYSTEM (K133062)Innovative Visual Systems2014-06-20
PERSEUS A500 (K133886)Draeger Medical GmbH2014-06-20
SERVO-I VENTILATOR SYSTEM (K123149)Maquet Critical Care AB2014-06-20
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) (K140610)Hartalega NGC Sdn. Bhd.2014-06-20
VITEK 2 AST GP CEFTAROLINE (K141149)bioMerieux, Inc.2014-06-20
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (K140083)Nanosphere, Inc.2014-06-20
ECHO TIP ULTRA FIDUCIAL NEEDLE (K141356)Wilson-Cook Medical, Inc.2014-06-20
SUREFLEX LITHOTRIPSY LASER FIBERS (K140679)American Medical Systems2014-06-20
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Every clearance here is in the API, with alerts when new ones post.