Atlas FDA

2014

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

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RecordFirmDate
AVACEN 100 (K133981)Avacen, Inc.2014-08-15
MASTERSURG / EXPERTSURG (K140308)Kaltenbach & Voigt GmbH2014-08-15
ALIVECOR HEART MONITOR (K140933)AliveCor, Inc.2014-08-15
EXACTECH CERVICAL SPACER SYSTEM (K141129)Exactech, Inc.2014-08-15
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS (K132049)Choicespine2014-08-15
ARTHREX ANKLE FUSION PLATING SYSTEM (K141735)Arthrex, Inc.2014-08-15
ENDLESSFIBER REUSABLE SURGICAL LASER FIBER (K140366)Hogue Surgical, LLC2014-08-15
VONFLEX S BITE (K140966)Vericom Co., Ltd.2014-08-15
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM (K130720)Synthes (USA) Products, LLC2014-08-14
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE (K140737)Straumann USA, LLC2014-08-14
LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED (K141153)Covidien2014-08-14
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K141281)Fresenius Medical Care Renal Therapies Group, LLC2014-08-14
WHITNEY MEDICAL SOLUTIONS ESHIELD (K141438)Whitney Medical Solutions2014-08-14
TEMPUS PRO WITH ENHANCED FEATURES (K133973)Remote Diagnostic Technologies , Ltd.2014-08-14
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS (K140508)Zimmer, Inc.2014-08-14
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT (K140232)Siemens Medical Solutions USA, Inc.2014-08-14
KIVA VCF TREATMENT SYSTEM (K141141)Benvenue Medical, Inc.2014-08-14
OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM (K132633)Ok Biotech Co., Ltd.2014-08-14
FINGERTIP PULSE OXIMETER (K141128)Beijing Choice Electronic Technololgy Co., Ltd.2014-08-13
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES (K141517)Zimmer, Inc.2014-08-13
ARTHREX FIBERTAK SUTURE ANCHOR (K140476)Arthrex, Inc.2014-08-13
3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER (K140392)3M Company2014-08-13
0.9% SODIUM CHLORIDE FLUSH SYRINGE (K133685)Am USA2014-08-13
FIBERGRAFT BG MORSELS (K141956)Prosidyan, Inc.2014-08-13
ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR (K140782)Celleration, Inc.2014-08-13
ZIMMER PERIARTICULAR LOCKING SYSTEM (K141734)Zimmer, Inc.2014-08-13
BUZZY (K130631)Mmj Labs, LLC2014-08-13
Elecsys Estradiol III CalSet (K142021)Roche Diagnostics2014-08-12
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) (K134014)Remote Diagnostic Technologies , Ltd.2014-08-12
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K133358)Nidek Co., Ltd.2014-08-12
LLD EZ (K142116)Spectranetics, Inc.2014-08-12
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD (K141225)Olympus Winter & Ibe GmbH2014-08-12
BAHADIR STERILIZATION TRAYS (K131407)Bahadir USA Corp.2014-08-12
DA VINCI FIREFLY IMAGING SYSTEM (K141077)Intuitive Surgical, Inc.2014-08-12
POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) (K140988)Hebei Hongsen Plastics Technology Co, Ltd.2014-08-12
ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS (K133255)Dentalpoint AG2014-08-12
CATARHEX 3 (K133562)Oertli Instrumente AG2014-08-12
CUTERA PICOSECOND LASER SYSTEM (K133945)Cutera, Inc.2014-08-11
NEUROBLATE SYSTEM (K141983)Monteris Medical Corp.2014-08-11
EMBRYOVIEWER SOFTWARE (K133712)Unisense Fertilitech A/S2014-08-08
SAVINA 300 SAVINA 300, COUNTRY VARIANTS (K121886)Draeger Medical GmbH2014-08-08
LITHO (K141101)Quanta System Spa2014-08-08
HYDROCLEANSE WOUND CARE SOLUTION (K141012)Oculus Innovative Sciences2014-08-08
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS (K133751)Diamond Diagnostics, Inc.2014-08-08
SENSILIGHT/ SENSILIGHT PLUS (K140381)El Global Trade, Ltd.2014-08-08
WALKAIDE SYSTEM (K140886)Innovative Neurotronics, Inc.2014-08-08
BLUE NITRILE POWDER FREE EXAM GLOVES (K133325)Shandong Xinshi Medical Products Co., Ltd.2014-08-08
SPORVIEW PLUS BI TEST PACK (K140620)Crosstex International2014-08-07
LATERAL VBR SYSTEM (K140563)Nu Vasive, Incorporated2014-08-07
Straumann Bone Level NC Angled Screw Retained Abutments (K141871)Straumann USA, LLC2014-08-07
KIMGUARD ONE-STEP STERILIZATION WRAP (K141612)Kimberly-Clark Health Care2014-08-07
SAGITTILT (K141787)Orfit Industries NV2014-08-07
LITHO DK30 (K141403)Quanta System Spa2014-08-07
NASOPORE-FD (K141423)Polyganics B.V.,2014-08-07
TITAN 11 (K133695)Gemss Medical Systems Co., Ltd.2014-08-07
Z-LINK CERVICAL (K141005)Zavation, LLC2014-08-07
PATHASSIST LED LIGHT FIBER (K141916)Entellus Medical, Inc.2014-08-07
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE (K133538)Olympus Corporation of the Americas2014-08-07
PREMVIA (K134037)Biotime, Inc.2014-08-07
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (K131384)Kericure, Inc.2014-08-07
TON-95LH, PAX-I3D ORTHO (K132983)VATECH Co., Ltd.2014-08-07
VARIAX 2 SYSTEM (K141992)Stryker Trauma AG2014-08-07
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM (K141846)Siemens Medical Solutions USA, Inc.2014-08-07
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN (K141365)William A. Cook Australia Pty. , Ltd.2014-08-07
AAP LOQTEC CLAVICLE PLATES 2.7/3.5 (K141823)Aap Implantate AG2014-08-07
BREAST VOLUME NAVIGATOR (K141870)Metritrack, LLC2014-08-07
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES (K141209)Celonova Biosciences, Inc.2014-08-07
HI-TORQUE VERSATURN GUIDE WIRE (K141782)Abbott Vascular2014-08-07
ECLIPSE TREATMENT PLANNING SYSTEM (K141283)Varian Medical Systems, Inc.2014-08-07
LCD MONITOR (K140956)Nordicneurolab2014-08-07
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K133168)Wrp Asia Pacific Sdn. Bhd.2014-08-07
SONICISION CORDLESS ULTRASONIC DISSECTOR (K141371)Covidien, Formerly Valleylab, A Division of Tyco H2014-08-07
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K141236)Boston Scientific Corporation2014-08-07
MAGELLAN ROBOTIC SYSTEM (K141614)Hansen Medical2014-08-07
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM (K141241)Synthes (USA) Products, LLC2014-08-07
MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (K140812)Medical Illumination International, Inc.2014-08-07
MINIMA S SYSTEM (K141327)Lima Corporate S.P.A.2014-08-06
AEQUALIS REVERSED SHOULDER PROSTHESIS (K140478)Tornier S.A.S.2014-08-06
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS (K140686)The Binding Site Group , Ltd.2014-08-06
ASTROGLIDE NATURAL (K141581)Biofilm, Inc.2014-08-06
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS (K141336)Varian Medical Systems, Inc.2014-08-06
SAAD PATIENT MONITOR (SPM) (K133222)Hanin Medical Services Co., Ltd.2014-08-06
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT (K133803)Diazyme Laboratories2014-08-06
IQ TECHNOLOGIES (K131290)Iq Technologies, Inc.2014-08-06
ISY (K133991)Altatec GmbH2014-08-06
CD HORIZON SPINAL SYSTEM (K141494)Medtronic Sofamor Danek USA, Inc.2014-08-06
STARLITE-OM, LIGHT EFFECTS, THIBIANT (K133546)Ps Advanced Engineering2014-08-06
NORAS OR HEAD HOLDER FLEXIBILITY (K133506)Noras Mri Products GmbH2014-08-06
TANDEMHEART VENO-VENOUS CANNULA (K140999)Cardiacassist, Inc.2014-08-06
X-REPAIR (K141394)Synthasome2014-08-06
ORTOMED (K131348)Infomed Servicios Informaticos S.L.2014-08-05
CAPNOSTREAM20P WITH HIFI C02 MONITORING (K123690)Oridion Medical 1987 , Ltd.2014-08-05
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS (K141056)Stryker Orthopaedics2014-08-05
VITEK 2 AST - YEAST FLUCONAZOLE (K133817)bioMerieux, Inc.2014-08-05
INTRAVASCULAR ADMINISTRATION SET (K140175)Delta Med Spa2014-08-05
Terumo Pen Injector Needle 34 (K140516)Kofu Factory of Terumo Corp.2014-08-05
RHYTHMSTAR SYSTEM (K141813)RhythMedix, LLC2014-08-05
FIT BELT (K133108)Hong Qiangxing (Shenzhen) Electronics Limited2014-08-05
TURBO-JECT PICC SETS (K141818)Cook Corporated2014-08-05
CLOSURERFG RADIOFREQUENCY GENERATOR (K141858)Covidien2014-08-05
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Every clearance here is in the API, with alerts when new ones post.