Atlas FDA

2014

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

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RecordFirmDate
CP RELIEF WAND (K133779)Mid-America Medical Innovations, LLC2014-05-30
ULTRAPRO COMFORT PLUG (K133198)ETHICON, Inc.2014-05-30
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE (K132730)Medtronic, Inc.2014-05-30
TERASON USMART3300 ULTRASOUND SYSTEM (K140773)Teratech Corp.2014-05-30
WATCH-PAT200U (WP200U) (K133859)Itamar Medical , Ltd.2014-05-30
FAMILY HEALTHWARE (K132173)Sanitas, Inc.2014-05-30
EUROIMMUN ANTI-PLA2R IFA (DEN140002)Euroimmun US2014-05-29
KOALA TOCO (K140163)Clinical Innovations, LLC2014-05-29
MOVES SLC (K140049)Thornhill Research, Inc.2014-05-29
DRIVE RAIL SYSTEM (K140822)Devise Ortho, Inc.2014-05-29
JOURNEY II BCS CONSTRAINED INSERTS (K140555)Smith & Nephew, Inc.2014-05-29
SENTIO MMG (K131304)Innovative Surgical Solutions, LLC ("Iss")2014-05-29
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (K131600)Teco Diagnostics2014-05-29
XGEO GF50 (K140326)Samsung Electronics Co., Ltd.2014-05-29
MEDI PEN NEEDLE (K131954)Shanghai Carelife International Trading Co. , Ltd.2014-05-29
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY (K132506)Michael D Williams Dds PA2014-05-29
VARIAX 2 COMPRESSION PLATING SYSTEM (K140565)Stryker Trauma AG2014-05-29
PEEK CAGE FOR THE VERTEBRAL SPINE (K132852)Neoortho Produtos Ortopedicos S/A2014-05-29
S.E.A.L. FRACTURE FUSION TUBE (K140158)Dne, LLC2014-05-29
NIGHT SHIFT (K140190)Advanced Brain Monitoring, Inc.2014-05-29
CLEARVIEW TOTAL (K131781)Clinical Innovations, LLC2014-05-28
REHASTIM 2, ERIGOPRO (FES) (K132416)Hasomed GmbH2014-05-28
A-DEC/W&H ELECTRIC HANDPIECE MOTOR (K133776)A-Dec, Inc.2014-05-28
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY (K132801)Siemens Healthcare Diagnostics, Inc.2014-05-28
VALENTINE STEEL WHEELCHAIR (K130017)Valentine Intl. , Ltd.2014-05-28
RAYSERT PLUS INJECTOR (K141091)Rayner Intraocular Lenses , Ltd.2014-05-28
ELASTIC IMPRESSION MATERIAL (K133071)Rizhao Huge Dental Industry Co., Ltd.2014-05-28
CLEARVIEWHD (K140139)Clearview Diagnostics, Inc.2014-05-28
LIFEBORNE INFANT RESUSCITATOR (K140707)International Biomedical2014-05-28
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE (K140509)Biomet Manufacturing, LLC2014-05-28
XGEO GU60A (K140332)Samsung Electronics Co., Ltd.2014-05-28
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) (K133316)Epimed International, Inc.2014-05-28
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481)St. Jude Medical, Inc.2014-05-28
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (K140127)Pontis Orthopaedics, LLC2014-05-28
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M (K133953)Hartalega Sdn Bhd2014-05-28
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN (K133956)Hartalega Sdn Bhd2014-05-28
XGEO GC80 (K140334)Samsung Electronics Co., Ltd.2014-05-28
SKYHAWK INTERBODY FUSION SYSTEM (K140709)Orthofix, Inc.2014-05-27
ACESSA GUIDANCE SYSTEM (K132744)Halt Medical, Inc.2014-05-27
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K140423)Conformis, Inc.2014-05-27
DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM (K140038)Curexo Technology Corporation2014-05-27
Best-AV2 Pro-Sport(tm) (K123099)Avazzia, Inc.2014-05-23
VIBRALUNG ACOUSTICAL PERCUSSOR (K133057)Westmed, Inc.2014-05-23
MINNIE (K133405)Elettronica Valseriana Srl2014-05-23
FMWAND HANDPIECE SE (K140384)Domain Surgical, Inc.2014-05-23
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) (K132684)Medecom Sarl2014-05-23
TIGHTRAIL MINI (K141131)Spectranetics, Inc.2014-05-23
MYSPINE PEDICLE SCREW PLACEMENT GUIDES (K132788)Medacta International2014-05-23
SHERPA PAK TRANSPORTER (K133694)Paragonix Technologies, Inc.2014-05-23
CORCAM HEART MONITOR (K140548)Corcam Technologia, SA2014-05-23
APLIO ARTIDA, V3.2 (K140729)Toshiba America Medical Systems, In.C2014-05-23
WALLFLEX BILIARY RX STENT SYSTEM (K140630)Boston Scientific2014-05-23
VIVID T8/VIVID T8 PRO (K141067)GE Healthcare2014-05-23
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET (K133173)Teleflexmedical, Inc.2014-05-23
NUTRA LIGHT BLUE (K132838)Nutra Luxe MD, LLC2014-05-23
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL (K140522)Randox Laboratories Limited2014-05-22
CARPENTIER BI-CAVAL FEMORAL CANNULA (K140192)Medtronic, Inc.2014-05-22
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM (K133790)Andon Health Co, Ltd.2014-05-22
NEXUS NIS-6P LUER ACTIVATED DEVICE (K133351)Nexus Medical, LLC2014-05-22
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT (K133121)Sam Medical Products2014-05-22
EV1000 CLINICAL PLATFORM (K131892)Edwards Lifesciences, LLC2014-05-22
CAPTIA MEASLES IGM (K140455)Trinity Biotech USA2014-05-22
EVEREST SPINAL SYSTEM (K140529)K2m, LLC2014-05-22
SYNERGY (K123876)Odontit S.A.2014-05-22
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE (K132681)Sol-Millennium Medical, Inc.2014-05-22
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS (K140454)Medtronic Sofamor Danek USA, Inc.2014-05-22
ANS1 SOFTWARE (K140412)Ld Technology, LLC2014-05-22
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER (K140027)Materialise NV2014-05-22
SALVATION 3DI PLATING SYSTEM (K140792)Wrightmedicaltechnologyinc2014-05-22
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE (K141220)Thermo Fisher Scientific (Life Technologies Holdin2014-05-22
ANTHRACIS REAL-TIME PCR ASSAY (K140426)Centers For Disease Control and Prevention (CDC)2014-05-22
ZOLL X SERIES (K133269)Zoll Medical Corporation, World Wide Headquarters2014-05-22
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR (K131588)Edwards Lifesciences, LLC2014-05-22
ISE INDIRECT NA, K, C1 FOR GEN 2 (K140373)Roche Diagnostics2014-05-22
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT (K140151)Btg International, Inc.2014-05-21
CARDIOHELP SYSTEM (K133598)Maquet Cardiopulmonary, AG2014-05-21
NOVOFINE PLUS 32G 4 MM (K133738)Novo Nordisk, Inc.2014-05-21
TRINICA ANTERIOR LUMBAR PLATE SYSTEM (K140611)Zimmer Spine, Inc.2014-05-21
HYGEDENT ALGINATE IMPRESSION MATERIAL (K140074)Hygedent, Inc.2014-05-21
GALAFLEX MESH (K140533)Tepha, Inc.2014-05-21
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER (K134043)Kaz USA, Inc (A Subsidiaryof Kaz Inc)2014-05-21
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) (K132937)Harvest Dental Products, LLC2014-05-21
MOTEX POWDERED NITRILE SURGICAL GLOVES (K132802)Shanghai Motex Healthcare Co., Ltd.2014-05-21
SPRINGTMS TOTAL MIGRAINE SYSTEM (K140094)Eneura Therapeutics, LLC2014-05-21
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM (K131609)Xiamen Double Engine Medical Material Co., Ltd.2014-05-21
SILC FIXATION SYSTEM (K133482)Globus Medical, Inc.2014-05-21
SOLUM IV BONE VOID FILLER (K132470)Spinesmith Partners, Llp2014-05-21
SKINTACT (K140340)Leonhard Lang GmbH2014-05-21
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM (K140169)Cook Incorporated2014-05-21
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO (K133428)Medikro OY2014-05-21
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K140448)Becton, Dickinson & CO2014-05-20
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE (K140165)Medtronic, Inc.2014-05-20
BD VIPER LT SYSTEM (K140447)Becton, Dickinson and Company2014-05-20
ASAP OTC WOUND DRESSING GEL (K140483)Abl Medical, LLC2014-05-20
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K141023)Ellipse Technologies, Inc.2014-05-20
GENERAL AND PLASTIC SURGERY (K140835)Scion Medical Technologies, LLC2014-05-20
ACUMED SUTURE ANCHOR SYSTEM (K140925)Acumed, LLC2014-05-20
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K140446)Becton, Dickinson & CO2014-05-20
Y WIRE 2 (K140576)Safewire, LLC2014-05-20
NAMSA CHEMICAL PROCESS (K132291)North American Science Assoc., Inc.2014-05-20
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Every clearance here is in the API, with alerts when new ones post.