Atlas FDA

2014

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

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RecordFirmDate
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION (K141756)Draeger Medical Systems, Inc.2014-12-12
Bovie Ultimate High Frequency Electrosurgical Generator (K142975)Bovie Medical Corporation2014-12-12
POOL NORM (K142132)Diagnostics Stago S.A.S.2014-12-12
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (K142384)Qualimed Srl2014-12-12
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM (K140091)Megagen Implant Co., Ltd.2014-12-12
SAPPHIRE INFUSION PUMP (K141389)Q Core Medical , Ltd.2014-12-11
iTotal Posterior Stabilized (PS) Knee Replacement System (K142404)Conformis, Inc.2014-12-11
Varian Head Frame (K142560)Varian Medical Systems, Inc.2014-12-11
Bi-Portal Bone Graft Delivery Device (K142661)Spinal Surgical Strategies, LLC2014-12-11
IBIS PEDICLE SCREW SYSTEM (K142146)Ortho Development Corp.2014-12-11
AngioVac Circuit (K142607)Angiodynamics2014-12-11
G7 OSSEOTI ACETUBLAR SHELLS (K140669)Biomet, Inc.2014-12-11
OVINE TISSUE MATRIX(OTM) (K141053)TELA Bio, Inc.2014-12-11
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (K142800)Co-Innovation Biotech Co., Ltd.2014-12-11
MD210C3 21.3 Diagnostic Imaging LCD Monitor (K142951)Nec Display Solutions , Ltd.2014-12-10
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) (K142343)Tangshan Hongyun Plastic Products Co., Ltd.2014-12-10
AmpliVue Bordetella Assay (K143206)Quidel Corporation2014-12-10
Crystal ®; Mosaic ®; Vertu ® (K133218)Spinal Elements, Inc.2014-12-10
LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS (K141463)DiaSorin, Inc.2014-12-10
eSie Apps Suite (K143254)Siemens Medical Solutions USA, Inc.2014-12-10
AMERIWATER OZONE DISINFECTION SYSTEM (K141213)Ameriwater2014-12-10
DISTAL ACCESS TORQUE DEVICE (K141054)Distal Access, LLC2014-12-10
HICURA HAND INSTRUMENTS (K140624)Olympus Winter & Ibe GmbH2014-12-10
Orthofix True Lok Hexapod System VI.3 (K143125)Orthofix Srl2014-12-10
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810)Becton, Dickinson and Company2014-12-10
12 mm Endoscopes and Accessories (K142683)Intuitive Surgical, Inc.2014-12-10
EP NAVIGATOR REL. 5.0 (K142126)Philips Medical Systems Nederland B.V.2014-12-09
TOTAL PROTEIN URINE/CSF GEN.3 (K141925)Roche Diagnostics Operations (Rdo)2014-12-09
H60 V2.00 Diagnostic Ultrasound System (K143264)Samsung Medison Co., Ltd.2014-12-09
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm (K142547)Covidien2014-12-09
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit (K143208)C.R. Bard, Inc.2014-12-09
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) (K140224)Euroimmun US2014-12-09
TWO SKIN TREATMENT SYSTEM (K141507)Syneron Medical, Ltd.2014-12-08
ORTHOFIX GALAXY WRIST (K141760)Orthofix Srl2014-12-08
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (K141795)R & D Batteries, Inc.2014-12-08
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR (K141557)Gallini Medical Devices, Srl2014-12-08
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (K140971)Randox Laboratories Limited2014-12-08
GenPrime Snap-Top Split Key Cup (K140665)Genprime, Inc.2014-12-08
Valeo C Spacer System, Valeo II C IBF Device (K142264)Amedica Corp.2014-12-08
Hospira Extension Set (K142433)Hospira, Inc.2014-12-08
Neo Total Knee System (K142388)New Era Orthopedics, LLC2014-12-05
Passeo-35 PTA Catheter (K142379)Biotronik, Inc.2014-12-05
XN CHECK (K141964)Streck2014-12-05
CARDIOSPY ECG HOLTER SYSTEMS (K140847)Labtech Kft.2014-12-05
XN CAL (K141962)Streck2014-12-05
SYSMEX XN SERIES (K141681)Sysmex America, Inc.2014-12-05
PESSARY (K132313)Eis Corporation2014-12-05
IGROW II HAIR GROWTH SYSTEM (K140931)Apira Science, Inc.2014-12-05
Discovery MR750 3.0T (K142361)Ge Medical Systems, LLC2014-12-05
LYTHOS DIGITAL IMPRESSION SYSTEM (K141611)Ormco Corp.2014-12-05
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] (K141701)Isoaid, LLC2014-12-05
Schoelly Laparoscope (K143221)Schoelly Fiberoptic GmbH2014-12-05
Vinyl Co-Polymer Powder Free Examination Gloves (K142409)Grand Work Plastic Products Co., Ltd.2014-12-05
XN CAL PF (K141955)Streck2014-12-05
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) (K143194)Siemens Healthcare Diagnostics, Inc.2014-12-05
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT (K142052)Orthofix Srl2014-12-05
WaterProof PROFILER (K142431)Sun Nuclear Corporation2014-12-05
ADVIA Centaur HAV total assay (K142758)Siemens Healthcare Diagnostics, Inc.2014-12-05
QUALITY REPORTS (K142142)Sun Nuclear Corporation2014-12-05
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (K142365)Focus Diagnostics2014-12-05
IV ADMINISTRATION SET WITH HAND PUMP (K140838)B.Braun Medical, Inc.2014-12-05
Siemens 3.0T PROCURE Array Coil (K142676)Resonance Innovations, LLC2014-12-05
ONEFIT HIP PLANNER (K142671)Onefit Medical2014-12-05
Viscoelastic Injector (K143205)Sight Sciences, Inc.2014-12-05
TOTAL COMPRESSION PLATING SYSTEM (K143025)Wrightmedicaltechnologyinc2014-12-05
XN CHECK BF (K141957)Streck2014-12-05
NAVIGABLE BRAIN BIOPSY CANNULA SET (K140705)Izi Medical Products2014-12-05
RADAR VASCULAR COMPRESSION DEVICE (K142122)Advanced Vascular Dynamics2014-12-04
SafeAir Smoke Pencil (K143145)Lina Medical Aps2014-12-04
NATURE'S BOND 600 AND NATURE'S BOND 603 (K142168)Devon Medical Products, Inc.2014-12-04
PULSE OXIMETER (K141105)Hunan Accurate Bio-Medical Technology Co., Ltd.2014-12-04
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM (K141632)Medtronic Sofamor Danek USA, Inc.2014-12-04
VESOFLOW PLUS DVT COMPRESSION DEVICE (K141064)Caremed Supply, Inc.2014-12-04
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES (K141613)Zibo Goldenline Plastic Product Co., Ltd.2014-12-04
CUROS RED PORT PROTECTOR (K140657)Ivera Medical, Inc.2014-12-04
B TRAVELSAVVY SHARPS CONTAINER (K140285)Bellegrove Medical Supply, Inc.2014-12-04
Endovascular Stent Planning Software (K143079)Vital Images, Inc.2014-12-04
ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) (K142728)Medical Compressions System (Dbn) , Ltd.2014-12-04
MARK3 (K141092)Cavex Holland BV2014-12-04
X TWIN SYSTEM (K133496)Roesys GmbH2014-12-03
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR (K141287)Huikang Glove Co., Ltd.2014-12-03
ST AIA-PACK PROG II Calibrator Set (K143144)Tosoh Bioscience, Inc.2014-12-03
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER (K141529)Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S2014-12-03
SURVEYOR S4 MOBILE MONITOR (K141020)Mortara Instrument, Inc.2014-12-03
AliveCor Heart Monitor (K142672)AliveCor, Inc.2014-12-03
SYNGO.CT COLONOGRAPHY (K140920)Siemens Medical Solutions USA, Inc.2014-12-03
CLEARVIEW (K133373)Neusoft Medical Systems Co., Ltd.2014-12-03
ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
12 mm & Stapler Bladeless Obturators (K143217)Intuitive Surgical, Inc.2014-12-03
ENDOLUMINAL OCCLUSION SYSTEM (EOS) (K133924)Artventive Medical Group, Inc.2014-12-03
MAXPOWER RELIEF (K141978)Omron Healthcare, Inc.2014-12-03
M3290B Philips IntelliVue Information Center iX (K143057)Philips Medical Systems2014-12-03
5000Z FIREFLY SYSTEM (K133502)Prizm Medical, Inc.2014-12-03
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141279)Wanghui Glove Co., Ltd.2014-12-03
INMODE WMFACE DEVICE (K140926)Inmode MD , Ltd.2014-12-03
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (K140589)Mesa Laboratories, Inc.2014-12-03
STERILUCENT SELF-SEAL STERILIZATION POUCH (K141412)Gs Medical Packaging, Inc.2014-12-03
MAC 800 Resting ECG Analysis System (K142288)Ge Medical Systems China Co., Ltd.2014-12-03
MEDUSA VASCULAR PLUG, (K140796)Endoshape, Inc.2014-12-02
STOPLOSS JONES TUBE (K140290)Ljt Surgical, Ltd.2014-12-02
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Every clearance here is in the API, with alerts when new ones post.