Atlas FDA

2014

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K141305)Shijiazhuang Richful Plastic Co., Ltd.2014-08-27
GENESIS REUSABLE RIGID CONTAINER SYSTEM (K140850)Carefusion 2200, Inc.2014-08-27
CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) (K140338)Creganna-Tactx Medical2014-08-27
PREVANTICS DEVICE SWAB (K132380)Professional Disposables International, Inc.2014-08-27
ALL-CERAMIC ZIRCONIA BLOCK (K141162)Rizhao Huge Dental Industry Co., Ltd.2014-08-27
VixWin Platinum (K141451)Imaging Sciences International (Dba Gendex, LLC)2014-08-26
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR (K141021)Hl Rubber Industries Sdn Bhd2014-08-26
CAYA CONTOURED DIAPHRAGM (K140305)Kessel Medintim GmbH2014-08-26
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) (K141497)Osstem Implant Co., Ltd.2014-08-26
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS (K141095)Stryker Corporation2014-08-26
CONFIRM BIOACTIVE (K133678)Globus Medical, Inc.2014-08-26
BASAL DIGITAL THERMOMETER (K141505)K-Jump Health Co., Ltd.2014-08-26
VERITRACT ENTERAL FEEDING TUBE SYSTEM (K133334)Veritract, Inc.2014-08-26
DIOTECH LASER FIBER (K140458)Diotech CO2014-08-26
TENS (K133979)Sunmas (H.K.) Trading Limited2014-08-26
SLIT LAMP SL-D701 (K133667)Topcon Corp.2014-08-26
VERTIFORM POSTERIOR FIXATION SYSTEM (K141291)Next Orthosurgical2014-08-26
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS (K141294)Kimberly-Clark Corp.2014-08-25
MEDELA THOPAZ+ (K141553)Medela AG2014-08-25
ORTHOHUB EXTERNAL FIXATOR SOFTWARE (K140550)Orthohub, Inc.2014-08-25
3B RESMART BPAP 25A, BMC RESMART BPAP 25A (K133769)3B Medical, Inc.2014-08-25
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K133322)Steritec Products Mfg Co, Inc.2014-08-25
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS (K142036)B.Braun Medical, Inc.2014-08-25
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (K142044)Guangzhou Wondfo Biotech Co., Ltd.2014-08-25
COMPACTCATH INTERMITTENT URINARY CATHETER (K140945)Compactcath, Inc.2014-08-22
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 (K140210)Bionime Corporation2014-08-22
LUBRIGYN CREAM (K132772)Uniderm Farmaceutici Srl2014-08-22
EPX-4440HD DIGITAL VIDEO PROCESSOR (K140149)Fujifilm Medical Systems U.S.A, Inc.2014-08-22
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP (K140944)Atheromed, Inc.2014-08-22
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE (K140946)Novabone Products, LLC2014-08-22
IKNEE DISTAL FEMORAL CUTTING GUIDE (K140689)Evergreen Orthopedic Research Lab2014-08-22
CONSTELLATION VISION SYSTEM (K141065)Alcon Research, Ltd.2014-08-22
VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE (K141288)Applied Medical Resources2014-08-22
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, (K141446)Natus Medical Incorporated2014-08-22
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR (K141083)Microlife Intellectual Property GmbH2014-08-22
PRECEPTIS TYMPANOSTOMY TUBE INSERTER (K133921)Preceptis Medical2014-08-22
PERSONAL KINETIGRAPH (PKG) SYSTEM (K140086)Gkc Manufacturing Pty, Ltd.2014-08-22
MERCURY SPINAL SYSTEM (K141372)Spinal Elements, Inc.2014-08-22
VAPRO INTERMITTENT CATHETER (K141642)Hollister Incorporated2014-08-22
VYNTUS/ SENTRYSUITE PRODUCT LINE (K133925)Carefusion Germany 234 GmbH2014-08-22
X-PORTE ULTRASOUND SYSTEM (K142017)FUJIFILM Sonosite, Inc.2014-08-22
CVI42 (K141480)Circle Cardiovascular Imaging, Inc.2014-08-22
BREAST SPEEDER CX, GRID HOLDER CX (K142002)Quality Electrodynamics, LLC2014-08-22
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS (K141509)Medos Sarl2014-08-22
MUSTANG BALLOON DIALATION CATHETER (K141597)Boston Scientific Corporation2014-08-22
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM (K133592)Neodent USA, Inc.2014-08-22
Medtronic DUET External Drainage and Monitoring System (DEN120017)Medtronic Neurosurgery2014-08-22
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML (K141930)Osseon, LLC2014-08-21
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER (K140028)Galt Medical Corp.2014-08-21
GEKO (K133638)Firstkind Limited2014-08-21
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM (K141567)Apira Science, Inc.2014-08-21
IONSIL GEL (K132326)Virchow Biotech Pvt, Ltd.2014-08-21
TENSYN BAND, TENSYN FRACTURE PLATES (K141264)Dallen Medical, Inc.2014-08-21
SB ANCHOR (K140600)Osstem Implant Co., Ltd.2014-08-21
ROMEO 2 PAD POSTERIOR AXIAL DEVICE (K141508)Spineart2014-08-21
VALOR HINDFOOT FUSION NAIL SYSTEM (K142121)Wrightmedicaltechnologyinc2014-08-21
MEDLINE ANTI-EMBOLISM STOCKING (K141127)Medline Industries, Inc.2014-08-21
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER (K141521)Boston Scientific Corporation2014-08-21
ALARIS SYSTEM WITH GUARDRAILS SUITE MX (K133532)Carefusion 303, Inc.2014-08-21
SMITH & NEPHEW DISPOSABLE FIN PUNCH (K141585)Smith & Nephew, Inc.2014-08-21
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM (K133706)Zl Microdent-Attachment GmbH & Co. KG2014-08-21
BELTER INFRA-RED EAR THERMOMETER (K140681)Shenzhen Belter Health Measurement and Analysis TE2014-08-21
SYMBIA 6.0 (K142006)Siemens Medical Solutions USA, Inc.2014-08-21
ORTHOHELIX STAPLE SYSTEM (K142148)Orthohelix Surgical Designs, Inc.2014-08-21
BARRX FLEX RFA ENERGY GENERATOR (K141357)Covidien Iic2014-08-21
SURGISEAL TWIST TOPICAL SKIN ADHESIVE (K141215)Adhezion Biomedical, LLC2014-08-21
INTRAOSSEOUS FIXATION SYSTEM (K141004)Orthohelix Surgical Designs, Inc.2014-08-21
NEXUS MIDLINE CT CATHETER (K140270)Health Line International Corporation2014-08-20
OBSIDIAN MILLING BLOCKS (K141788)Prismatik Dentalcraft, Inc.2014-08-20
TENURE4G (K140537)Den-Mat Holdings, LLC2014-08-20
MULTIPIEZO PRO, MULTIPIEZO (K140965)Mectron S.P.A.2014-08-20
ANKYLOS C/X IMPLANT SYSTEM (K140347)Dentsply Intl., Inc.2014-08-20
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD (K140748)Co-Innovation Biotech Co., Ltd.2014-08-20
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT (DEN140001)Kronus Market Development Associates, Inc.2014-08-20
STRAUMANN BONE LEVEL TAPERED IMPLANT (K140878)Straumann USA, LLC2014-08-20
HIOSSEN PROSTHETIC SYSTEM (K140507)Osstem Implant Co., Ltd.2014-08-20
NUTRA LIGHT RED (K141308)Nutra Luxe MD, LLC2014-08-20
LEICA FL800 (K141136)Leica Biosystems Richmond2014-08-19
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (K133952)bioMerieux, Inc.2014-08-19
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979)Philips Medical Systems Netherland BV2014-08-19
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE (DEN140016)Dexcom, Inc.2014-08-19
M.U.S.T PEDICLE SCREW SYSTEM (K141988)Medacta International2014-08-19
SONOSENTRY (K131285)Isonea, Ltd.2014-08-19
NOMAD MD 75K V HANDHELD X-RAY SYSTEM (K140723)Aribex, Inc.2014-08-19
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL (K141772)Siemens Healthcare Diagnostics, Inc.2014-08-19
OPA 30 SOLUTION (K140703)Ciden Technologies, LLC2014-08-19
SOLUTION SET/EXTENSION SET (K142011)Baxter Healthcare Corporation2014-08-18
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM (K140585)Curexo Technology Corporation2014-08-18
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER (K141769)Lightlab Imaging, Inc.2014-08-18
3M STERI-DRAPE FABRIC SURGICAL DRAPES (K140330)3M Healthcare2014-08-18
M.U.S.T. EXTENSION (K141044)Medacta International2014-08-18
BIOLOX DELTA CERAMIC OPTION HEADS (K141653)Biomet, Inc.2014-08-18
PHYSIOGLOVE ET SYSTEM (K133703)Commwell R&D , Ltd.2014-08-18
ENDOCYN ROOT CANAL IRRIGATION SOLUTION (K141352)Oculus Innovative Sciences2014-08-18
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE (K132518)Wellquest Intl., Inc.2014-08-17
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE (K141951)Medtronic, Inc.2014-08-15
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER (K141090)Medtronic, Inc.2014-08-15
HEMOSIL D-DIMER HS 500 CONTROL (K133582)Instrumentation Laboratory2014-08-15
CORMATRIX PROTECT ECM ENVELOPE (K140306)Cormatrix Cardiovascular, Inc.2014-08-15
RESPICONNECT ADAPTER (K140919)Trudell Medical Int'L2014-08-15
← Previous Next →

Track 2014 automatically

Every clearance here is in the API, with alerts when new ones post.