Atlas FDA

2014

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

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RecordFirmDate
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER (K132810)Boston Scientific Corp2014-02-28
LERADO, POWER WHEELCHAIR (K130982)Lerado Global (Macao Commercial Offshore) Limited2014-02-28
FIXOS SCREW SYSTEM (K133451)Stryker Trauma AG2014-02-28
PRESTO BREAST BIOPSY DEVICE (K133702)Sontina Medical, LLC2014-02-28
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM (K131896)Suzhou Anke Medical System Co., Ltd.2014-02-28
TENSYN BAND (K133858)Dallen Medical, Inc.2014-02-28
OSTEOMED EXTREMIFUSE SYSTEM (K140283)Osteomed2014-02-28
OXICARE FINGERTIP PULSE OXIMETER (K133090)Delbio Incorporation2014-02-28
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (K131334)Gold Standard Diagnostics2014-02-28
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (K131727)Ceragem Medisys, Inc.2014-02-28
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE (K132580)ETHICON, Inc.2014-02-28
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS (K130255)Abbott Laboratories2014-02-28
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133999)Cardiovascular Systems, Inc.2014-02-28
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (K131605)Roche Diagnostics2014-02-28
ND: YAG LASER SYSTEM (K133158)Beijing Toplaser Technology Co., Ltd.2014-02-28
BIOMARC FIDUCIAL MARKER (K132064)Carbon Medical Technologies, Inc.2014-02-28
SCENIUM (K133654)Siemens Medical Solutions USA, Inc.2014-02-28
THE DOME S6C (K133609)Nds Surgical Imaging2014-02-28
HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM (K131777)Hyper Technology, Inc.2014-02-28
ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K140178)Ellipse Technologies, Inc.2014-02-27
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA (K132811)Terumo Cardiovascular Systems Corporation2014-02-27
ARTHREX IBALANCE TKA SYSTEM (K133854)Arthrex, Inc.2014-02-27
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM (K133647)Eps Bio Technology Corp.2014-02-27
COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK (K133115)Abbott Medical Optics, Inc.2014-02-27
MADSEN ACCUSCREEN TYPE 1077 (K132957)Gn Otometrics2014-02-27
M SERIES PATIENT MONITOR (K131876)Mid-Link Consulting Co, Ltd.2014-02-27
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM (K133773)Thermo Fisher Scientific2014-02-27
U&U STERILE PISTON SYRINGE WITHOUT NEEDLE (K132553)U&U Medical Technology Co, Ltd.2014-02-27
TARGET3D FUSION (K140033)Convergent Life Sciences, Inc.2014-02-27
TRINIAS (K123508)Shimadzu Corporation2014-02-26
LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE (K133385)Broncus Medical, Inc.2014-02-26
EXCELERON BACTERIAL FILTERS (K131626)Exceleron Medical2014-02-26
NEMUS 2 SYSTEM (K133517)Eb Neuro S.P.A.2014-02-26
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) (K132889)Nucletron B.V.2014-02-26
EMERGE MEDICAL BONE PLATE SYSTEM (K133536)Emerge Medical2014-02-26
ARTHROSURFACE TOEMOTION (K132496)Arthrosurface, Inc.2014-02-26
STATUS DS OXY (K130650)Princeton BioMeditech Corp.2014-02-26
OSI Q SYSTEM ARTHROSCOPES (K133018)Orthopedic Sciences, Inc.2014-02-26
U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL (K123162)U&U Medical Technology Co, Ltd.2014-02-26
PRESSURE CONNECTING TUBE (K131770)Shenzhen Ant Hi-Tech Industrial Co., Ltd.2014-02-26
IFA 40: HEP-20-10 (K131791)Euroimmun US2014-02-26
EZONO 4000 (K140254)Ezono AG2014-02-26
SUREFIRE GUIDING CATHETER (K140034)Surefire Medical, Inc.2014-02-26
ANAL RECTAL OVERTUBE (K131598)United States Endoscopy Group, Inc.2014-02-26
ST SENSE NV 8 ARRAY COIL (K140282)Resonance Innovations, LLC2014-02-26
SYNGO.VIA MI WORKFLOWS (K133644)Siemens Medical Solutions USA, Inc.2014-02-25
CISNAP CLOSED INCISION SYSTEM (K133137)Spiracur, Inc.2014-02-25
EZ TRANSPORT CHAIR (K130517)Harris Medical, LLC2014-02-25
WONDFO MULTI-DRUG URINE TEST CUP, PANEL (K133968)Guangzhou Wondfo Biotech Co., Ltd.2014-02-25
UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM (K132690)Qisda Corporation2014-02-25
SFI-BAR IMPLANT ABUTMENTS (K132814)Sterngold Dental, LLC2014-02-25
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA (K133162)Materialise NV2014-02-25
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED (K132389)Daniel & Daniel Consulting2014-02-25
CD HORIZON SPINAL SYSTEM GROWTH ROD SET (K133904)Medtronic Sofamor Danek USA2014-02-25
MODIFIED HD GUIDE CATHETER (K133177)Concentric Medical, Inc.2014-02-25
PRESSON SPINAL FIXATION SYSTEM (K133287)Nexus Spine, LLC2014-02-25
SMILEBOND SYSTEM (K132599)Millennium Company, LLC2014-02-25
E-Z CHECK OZONE TEST STRIPS (K132344)Reprocessing Products Corporation (Rpc)2014-02-25
INSULIN PEN NEEDLE (K133058)Wenzhou Wuzhou Import & Export Co., Ltd.2014-02-25
RETRACTION PASTE (K130580)Dmg USA, Inc.2014-02-25
LEADLINER CS LEAD DELIVERY SYSTEM (K133501)Vascular Solutions, Inc.2014-02-25
INTONEMV (K134020)Incontrol Medical, LLC2014-02-25
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE (K140118)Cardica, Inc.2014-02-25
INSULIN PEN NEEDLE (K133059)Wenzhou Beipu Science & Technology Co., Ltd.2014-02-25
SE-601 SERIES ELECTROCARDIOGRAPH (K131503)Edan Instruments, Inc.2014-02-25
SICAT FUNCTION (K133320)Sicat GmbH & Co. KG2014-02-25
NEODENT IMPLANT SYSTEM (K133696)Jjgc Industria E Comercio DE Materiais Dentarios S2014-02-25
EXTRIMILOCK ANKLE PLATING SYSTEM (K133691)Osteomed LP2014-02-24
NEODENT IMPLANT SYSTEM (K133510)Jj Industria E Comercio DE Materiais Dentarios SA2014-02-24
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (K133447)Celonova Biosciences, Inc.2014-02-24
MATRICEL DENTAL BARRIER MEMBRANE (K123697)Matricel GmbH2014-02-24
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER (K133615)Well Lead Medical Co., Ltd.2014-02-24
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH (K133404)Phadia AB2014-02-24
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM (K131252)Covidien2014-02-24
AIR-FLOW HANDY 3.0 PERIO (K132480)E.M.S Electro Medical Systems S.A2014-02-24
DALTON LIFT CHAIR (K131909)Dalton Instrument Corp.2014-02-24
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & (K133625)Codman & Shurtleff, Inc.2014-02-24
MONITOR B40 (K133576)Ge Medical Systems China Co., Ltd.2014-02-21
FLAATZ 600 SERIES (FLAATZ 600/601) (K132842)Drtech Corp.2014-02-21
ADVIA CENTAUR TESTOSTERONE (TSTO) (K133491)Siemens Healthcare Diagnostics, Inc.2014-02-21
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, (K132219)Straumann USA, LLC2014-02-21
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (K133710)Lin-Zhi International, Inc.2014-02-21
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (K132039)Jedmed Instrument Co.2014-02-21
NOVOHIP TOTAL HIP SYSTEM (K132158)Novosource, Inc.2014-02-21
EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO (K133509)Biotest Medical Corp.2014-02-21
FREEDOM PCK COMPONENTS (K131481)Maxx Orthopedics, Inc.2014-02-21
AXIOM REG (K131066)Anthogyr Sas2014-02-21
OMNI PATENT MONITORS (K132229)Infinium Medical2014-02-21
OXYGEN GENERATOR LIQUEFIER - (OGL) (K131990)Essex Cryogenics of Missouri, Inc.2014-02-21
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA (K133409)Rayence Co., Ltd.2014-02-21
SHERPA PAK CARDIAC TRANSPORT SYSTEM (K133432)Paragonix Technologies, Inc.2014-02-21
LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM (K132874)Nucletron B.V.2014-02-21
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM (K132402)Nonin Medical, Inc.2014-02-21
POLAROID CONTACTSPOD (K131783)Viopti, Ltd.2014-02-21
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME (K132935)Siemens Medical Solutions USA, Inc.2014-02-21
T-TYPE D-KAT, R-TYPE D-KAT (K133234)Keeler Limited2014-02-21
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT (K133948)Bard Peripheral Vascular, Inc.2014-02-21
FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER (K132457)Biocare Asia Corporation , Ltd.2014-02-21
MEDLINE BIOPSY VALVE (K131426)Medline Industries, Inc.2014-02-21
PELLEFIRM (K132949)Ellman International, Inc.2014-02-20
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Every clearance here is in the API, with alerts when new ones post.