Atlas FDA

2013

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

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RecordFirmDate
MECTACER BIOLOX OPTION HEADS (K131518)Medacta International2013-11-04
WOLF LONG BONE PLATE SYSTEM (K131834)Toby Orthopaedics2013-11-04
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES (K131700)Boston Scientific Corp2013-11-04
X-PORTE ULTRASOUND SYSTEM (K133134)FUJIFILM Sonosite, Inc.2013-11-04
ARIX HAND SYSTEM (K131566)Jeil Medical Corporation2013-11-04
PETITE BASIC SYSTEM 701 ELT (K131420)Mego Afek AC , Ltd.2013-11-01
SCANNING LASERLINK (K130195)Lumenis, Inc.2013-11-01
ENAMELAST (K132109)Ultradent Products Inc. / Oratech, LLC2013-11-01
PERIMETER INTERBODY FUSION DEVICE (K131669)Medtronic Sofamor Danek USA, Inc.2013-11-01
SILK ROAD ACCESS CATHETER (K130649)Silk Road Medical, Inc.2013-11-01
RAYSCAN A-EXPERT 3D (K131695)Ray Co., Ltd.2013-11-01
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND (K132450)Kuraray Noritake Dental, Inc.2013-11-01
KLARITY VACUUM BAG, KLARITY MOLD CUSHION (K132124)Klarity Medical Products, LLC2013-11-01
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW (K130845)Ambu A/S2013-11-01
RAYSCAN A-EXPERT (K131693)Ray Co., Ltd.2013-11-01
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) (K132883)Hemodia Sas2013-11-01
QUIET/SILENT SCANNING SUITE (K132831)Siemens Medical Solutions USA, Inc.2013-11-01
CLEARPATH ALIGNER (K123514)Qserve America, Inc.2013-11-01
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924)Medtronic, Inc.2013-10-31
OSSEOFUSE DENTAL IMPLANT SYSTEM (K131748)Osseofuse, Inc.2013-10-31
IPS E.MAX CAD ABUTMENT SOLUTIONS (K132209)Ivoclar Vivadent, AG2013-10-31
PAXERAPACS (K132586)Paxeramed2013-10-31
INVOTEC LARYNGEAL ELECTRODE (K122040)Invotec International, Inc.2013-10-31
AMPCARE ESP THERAPY SYSTEM (K131222)Ampcare, LLC2013-10-31
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K131894)Nidek Co., Ltd.2013-10-31
ALTUS SPINE PEDICLE SCREW SYSTEM (K132280)Altus Partners2013-10-31
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO (K132995)Medtronic, Inc.2013-10-31
UNIQUE (K132705)Varian Medical Systems, Inc.2013-10-31
OFFROAD RE-ENTRY CATHETER SYSTEM (K131914)Boston Scientific Corp2013-10-31
GSB GLOBAL SPINAL BALANCE SYSTEM (K132014)Nuvasive, Inc.2013-10-31
FIRMAP CATHETER (K130827)Topera, Inc.2013-10-31
LUNA DENTAL IMPLANT SYSTEM (K123155)Shinhung Mst Co., Ltd.2013-10-31
SPIROTEL (K130784)Mir Medical Intl. Research Srl2013-10-30
MESO BILAYER SURGICAL MESH (K132025)Kensey Nash Corporation Dba Dsm Biomedical2013-10-30
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT (K132166)Maquet Cardiopulmonary, AG2013-10-30
STENTBOOST REL. 4 (K132305)Philips Medical Systems Nederland B.V.2013-10-30
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (K131893)Ajw Technology Consultants, Inc.2013-10-30
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (K131719)Medical Devices (Pvt) , Ltd.2013-10-30
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER (K131116)United Orthopedic Corporation2013-10-30
IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) (K133122)Siemens Healthcare Diagnostics, Inc.2013-10-30
MULTIVIEW (K132316)Hologic, Inc.2013-10-30
ARTHREX UNIVERS II CA HEADS (K130675)Arthrex, Inc.2013-10-30
SUNTOUCH EYE SPEAR (K132796)Huizhou Foryou Medical Devices Co., Ltd.2013-10-30
FLOWER BONE SCREW SET (K132248)Flower Orthopedics Corporation2013-10-30
SMITH & NEPHEW ULTRATAPE (K132357)Smith & Nephew, Inc.2013-10-30
DIPLOMAT (K130534)Diplomat Dental S.R.O.2013-10-30
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (K122783)Aesculap Implant System, Inc.2013-10-30
MYPATCH (K131190)Dms-Service, LLC2013-10-29
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM (K130274)Elite Surgical Supplies (Pty), Ltd.2013-10-29
2.5MM INLINE FUSION PLATE (K131867)Biomet, Inc.2013-10-29
REVERSE SHOULDER PROSTHESIS MONOBLOCK (K130048)Encore Medical L.P.2013-10-29
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (K130117)Network Medical Products, Ltd.2013-10-29
INSPIRATION VENTILATOR SYSTEM 5I/7I (K130178)eVent Medical, Ltd.2013-10-29
GUIDOR BIORESORBABLE MATRIX BARRIER (K132325)Sunstar Americas, Inc.2013-10-29
WOUNDWASH SALINE SPRAY (K123910)Neilmed Pharmaceuticals, Inc.2013-10-29
TX WHEELCHAIR CHASSIS (K131336)Jcm Seating Solutions, Ltd.2013-10-28
NAUTILUS SPINAL SYSTEM (K132866)Life Spine, Inc.2013-10-28
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES (K131446)Integra LifeSciences Corporation2013-10-28
JIAJIAN POINTOSELECT DIGITAL (K123958)Wuxi Jiajian Medical Instrument Co., Ltd.2013-10-28
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 (K132083)MicroVention, Inc.2013-10-28
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE (K132972)Medtronic, Inc.2013-10-28
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (K132126)Spectrum Spine, LLC2013-10-28
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (K132462)Hitachi Chemical Diagnostics, Inc.2013-10-28
ITCLAMP 50 (K132651)Innovative Trauma Care, Inc.2013-10-28
INSTINCT ENDOSCOPIC HEMOCLIP (K132809)Wilson-Cook Medical, Inc.2013-10-25
COVAMESH (K130428)Biomup S.A.2013-10-25
BIPOLAR FORCEPS (K131058)Boston Endo-Surgical Technologies, Inc.2013-10-25
MIRADRY SYSTEM (K131162)Miramar Labs, Inc.2013-10-25
RAUMEDIC-PTO-MONITORING-SYSTEM (K130529)Raumedic AG2013-10-25
BIOLIGHT BIODYNAM (K130866)Biolight AB2013-10-25
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY (K132227)Bio-Rad Laboratories2013-10-25
TRIA FAN SYSTEM (K130459)Tria Beauty, Inc.2013-10-25
OSSEOSPEED PROFILE EV (K130999)Dentsply Implants Manufacturing GmbH2013-10-25
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K132020)Cook, Inc.2013-10-25
DIAGNOSTIC ULTRASOUND SYSTEM (K132059)Advanced Instrumentations, Inc.2013-10-25
IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA (K133124)Siemens Healthcare Diagnostics, Inc.2013-10-25
TRELLIS-8 PERIPHERAL INFUSION SYSTEM (K130904)Covidien2013-10-25
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA (K123713)Immco Diagnostics, Inc.2013-10-25
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM (K132900)Intelligent Implant Systems, LLC2013-10-25
MAMMOGRAPHY VIEWER SMV658 (K132188)Fujifilm Medical System U.S.A., Inc.2013-10-25
MEDUSA VASCULAR PLUG (K123696)Endoshape, Inc.2013-10-25
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT (K131887)Church & Dwight Co., Inc.2013-10-24
ULTRACEM (K132255)Ultradent Products Inc. / Oratech, LLC2013-10-24
LOTUS (K131427)Spinal Elements, Inc.2013-10-24
(QUANTA SYSTEM) SURGICAL LASER FIBERS (K131473)Quanta System Spa2013-10-24
OMBRA TABLE TOP COMPRESSOR (K131881)Trudell Medical Intl.2013-10-24
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER (K131895)Fisher & Paykel Healthcare, Ltd.2013-10-24
MAK OSS FEMORAL KNEE COMPONENTS (K131393)Biomet Orthopedics Corp.2013-10-24
BIOPRO - INFINITY PLATE ANCHOR SYSTEM (K132510)Biopro, Inc.2013-10-24
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS (K122295)Core 3D Protech, S.L.2013-10-24
DA01 BLOOD GLUCOSE MONITORING SYSTEM (K132338)Delbio Incorporation2013-10-24
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132512)Ethicon Endo-Surgery, LLC2013-10-24
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER (K132556)Asahi Intecc Co., Ltd.2013-10-24
RIGHTEST CONTROL SOLUTION (K133003)Bionime Corporation2013-10-24
ACUSON S1000 / S2000 / S3000 (K132804)Siemens Medical Solutions USA, Inc. Ultrasound Gro2013-10-24
MARIGEN WOUND DRESSING (K132343)Kerecis Limited2013-10-23
DYNAMESH -CICAT (K131530)Feg Textiltechnik Forschungs-Und Entwicklungsgesel2013-10-23
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K132627)Honsun (Nantong) Co., Ltd.2013-10-23
WMT IMPLANTABLE K-WIRE (K132895)Wrightmedicaltechnologyinc2013-10-23
CALIX LUMBAR SPINAL IMPLANT SYSTEM (K131350)X-Spine Systems, Inc.2013-10-23
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Every clearance here is in the API, with alerts when new ones post.