Atlas FDA

2014

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

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RecordFirmDate
VARIAX DISTAL RADIUS PLATING SYSTEM (K133974)Stryker Leibinger GmbH2014-03-24
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW (K130550)Encore Medical L.P.2014-03-24
WITHINGS BLOOD PRESURE MONITOR (K133125)Withings2014-03-24
T:SLIM INSULIN DELIVERY SYSTEM (K133593)Tandem Diabetes Care, Inc.2014-03-24
PRODENSE BONE GRAFT SUBSTITUTE (K132656)Wrightmedicaltechnologyinc2014-03-24
QB TEST (K133382)Qbtech AB2014-03-24
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES (K133232)Kci USA, Inc. (Kinetic Concepts, Inc.)2014-03-24
IOVERA (K133453)Myoscience, Inc.2014-03-24
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (K133735)Yung Sheng Optical Co., Ltd.2014-03-21
XTRA (K131553)Sorin Group Deutschland GmbH2014-03-21
TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM (K140524)Teratech Corp.2014-03-21
KERATOR (K132144)LK Consulting Group USA, Inc.2014-03-21
NOVA FA DR SYSTEM (K133782)Sedecal., Sa.2014-03-21
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM (K133944)K2m, Inc.2014-03-21
SIMPLEXA HSV 1&2 DIRECT (DEN130049)Focus Diagnostics2014-03-21
ELIBRA SOFT-TISSUE FORCE SENSOR (K132104)Kamm & Associates2014-03-21
SAVE II, SAVE II BASIC (K131877)Automedx, Inc.2014-03-21
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131652)Lin-Zhi International, Inc.2014-03-21
DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID (K133786)Dornoch Medical Systems, Inc.2014-03-21
DISCOVERY PET/CT 710 (K133657)Ge Medical Systems, LLC2014-03-21
NS 2500 HOLMIUM LASER SYSTEM (K132607)New Star Lasers, Inc.2014-03-21
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET (K132011)Aea Srl2014-03-21
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (K132031)Axis-Shield Poc AS2014-03-21
ZIRTOUGH (K133211)Kuraray Noritake Dental, Inc.2014-03-20
VARIOGUIDE DRILL KIT (K132436)Mri Interventions, Inc.2014-03-20
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 (K133319)Lumenis, Ltd.2014-03-20
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE (K140253)Siemens Medical Solutions USA, Inc.2014-03-20
TRC-PEX, RADIC-SEALER (K132123)Km Corporation2014-03-20
DIGORA OPTIME (K133231)Instrumentarium Dental, Palodex Group OY2014-03-20
INTRA-LOCK DENTAL IMPLANTS (K133613)Intra-Lock International, Inc.2014-03-20
IM60/IM70 PATIENT MONITOR (K131971)Edan Instruments, Inc.2014-03-20
CAMBER SPINE DIAGON OBLIQUE CAGE (K134038)Camber Spine2014-03-20
CAMBER SPINE COVERIS CERVICAL CAGE (K133529)Camber Spine2014-03-20
TYBER MEDICAL TRAUMA SCREW (K133842)Tyber Medical, LLC2014-03-20
CAIR DRIVE, NEUTRACLEAR (K133073)Cair Lgl2014-03-20
STRYKER PEDIATRIC MANDIBLE DISTRACTOR (K133398)Stryker2014-03-20
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465)Ventana Medical Systems, Inc.2014-03-20
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 (K133958)Maquet Critical Care AB2014-03-20
CIRRUS PHOTO (K133217)Carl Zeiss Meditec, AG2014-03-19
SPEED XL (K133780)Biomedical Ent., Inc.2014-03-19
IVUE 500 (K133892)Optovue, Inc.2014-03-19
EMBOL-X INTRODUCER SHEATH (K140398)Edwards Lifesciences, LLC2014-03-19
SRS ENDOSCOPIC STAPLING SYSTEM (K132151)Medigus , Ltd.2014-03-19
MELYS ATRIAL FIBRILLATION SCREENING MONITOR (K132206)Advanced Fluidics, LLC2014-03-19
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (K133144)Crossbay Medical, Inc.2014-03-19
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM (K133374)Pioneer Surgical Technology, Inc. (Rti Surgical, I2014-03-19
SEAL SINGLE-USE BIOPSY VALVE (K133734)Endochoice, Inc.2014-03-19
METALLIC INTRAMEDULLARY NAIL SYSTEM (K132078)Tianjin Walkman Biomaterial Co., Ltd.2014-03-19
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII (K140105)The Binding Site2014-03-18
TINNITUS SOUNDSUPPORT (K133308)Oticon A/S2014-03-18
SPHINX JR (K132975)Allmed Systems, Inc.2014-03-18
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (K133894)Terumo Europe N.V.2014-03-18
ELECTRONIC THERMOMETER (K131210)Shenzhen Pump Medical System Co., Ltd.2014-03-18
ASAHI GAIA FIRST, SECOND, THIRD (K133865)Asahi Intecc Co., Ltd.2014-03-18
SATURN DENTAL IMPLANT (K131258)Cortex Dental Implants Industries , Ltd.2014-03-17
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (K134054)Bovie Medical Corporation2014-03-17
FORESEE (4C) IMAGING SYSTEM (K133209)Diagnostic Photonics, Inc.2014-03-17
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (K132944)Ge Hungary Kft2014-03-14
CERCOM II CEMENT (K132393)Denali Corporation2014-03-14
BG MORSELS (K132805)Prosidyan, Inc.2014-03-14
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) (K140345)C.R. Bard, Inc.2014-03-14
MANUKA FILL WOUND DRESSING (K131796)Links Medical Products, Inc.2014-03-14
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET (K133410)Diazyme Laboratories2014-03-14
RADIANCE 330 PROTON THERAPY SYSTEM (K134052)Protom International, Inc.2014-03-14
FREND TSH (REAGENT CARTRIDGE) (K131928)Nanoentek USA, Inc.2014-03-14
EZ-OX PLUS GENERATION II (K131386)Air Liquide Healthcare America2014-03-14
FASTOUCH FIXATION SYSTEM (K132698)Via Surgical , Ltd.2014-03-14
STERISPINE LC CAGE (K133893)Safe Orthopaedics2014-03-14
HEALTHINTERLINK BEACON (K133252)Healthinterlink, LLC2014-03-14
LUMENIS PULSE 120H (K140388)Lumenis, Ltd.2014-03-14
TRINIA (K133608)Bicon, LLC2014-03-14
CS 8100 3D (K133406)Trophy2014-03-14
CERASMART (K133824)GC America, Inc.2014-03-14
SW-THERM (K131899)Shenzhen Dongdixin Technology Co., Ltd.2014-03-14
VOLCANO IFR MODALITY (K133323)Volcano Corporation2014-03-14
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING (K133227)Varian Medical Systems, Inc.2014-03-14
OMNI ARC MONOBLOCK HIP STEM (K133381)Omnilife Science2014-03-13
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (K133015)Summit Medical, Inc.2014-03-13
ULTRACONGRUENT INSERT (K132752)United Orthopedic Corporation2014-03-13
E-Z LINK (K133097)Duoject Medical Systems, Inc.2014-03-13
MALLEABLE SUCTION INSTRUMENTS (K133665)Medtronic Navigation, Inc.2014-03-13
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (K133005)Instrumentation Laboratory CO2014-03-13
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM (K133205)Medtronic Sofamor Danek USA, Inc.2014-03-13
INTENSIF (K130501)Endymed Medical, Ltd.2014-03-13
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS (K133832)Total Joint Orthopedics, Inc.2014-03-13
ARSENAL SPINAL FIXATION SYSTEM (K133221)Alphatec Spine, Inc.2014-03-13
EMERGE MEDICAL DISTAL RADIUS SET (K140107)Emerge Medical2014-03-13
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL (K133764)Avery Dennison Belgie Bvba2014-03-13
CD HORIZON SPINAL SYSTEM (K140276)Medtronic Sofamor Danek2014-03-13
STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486)Bausch & Lomb2014-03-12
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM (K140119)Emerge Medical2014-03-12
TORRENT IRRIGATION SYSTEM (K140405)United States Endoscopy Group, Inc.2014-03-12
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM (K130981)Cordis Corp.2014-03-12
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM (K140098)Emerge Medical2014-03-12
BODIHEALTH SYSTEM (K131675)Eprt Technologies, Inc.2014-03-12
SURGISLEEVE WOUND PROTECTOR (K140064)Covidien2014-03-12
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER (K140318)Biosense Webster2014-03-12
SNAP WOUND CARE SYSTEM (K132080)Spiracur, Inc.2014-03-12
POLARIS SPINAL SYSTEM (K133746)Biomet Spine (Aka Ebi, LLC)2014-03-12
BONE SUPPRESSION SOFTWARE (K133442)Carestream Health, Inc.2014-03-11
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