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
PULSTAR LOGIX PUMP (K141609)Albahealth, LLC2014-07-15
HEARTWAY POWER WHEELCHAIR (K132856)Heartway Medical Products Co., Ltd.2014-07-15
LINSCAN 808, LINSCAN 980 (K141063)Gme (German Medical Engineering) GmbH2014-07-15
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM (K140753)Medivators2014-07-15
AESCULAP OPTILENE NONABSORBABLE SUTURE (K133890)Aesculap, Inc.2014-07-15
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE (K141532)Guangzhou Wondfo Biotech Co., Ltd.2014-07-14
PFX SPINOUS PROCESS FIXATION SYSTEM (K132765)Innovasis, Inc.2014-07-14
CONSENSUS VITALITE TIBIAL INSERT (K133919)Consensus Orthopedics, Inc.2014-07-14
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT (K140829)Beckman Coulter, Inc.2014-07-14
CD HORIZON SPINAL SYSTEM (K141605)Medtronic Sofamor Danek USA, Inc.2014-07-14
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM (K141301)Orthohelix Surgical Designs, Inc.2014-07-11
CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (K141582)Welch Allyn2014-07-11
SYSTEM CALIBRATER (K141388)Beckman Coulter Ireland, Inc.2014-07-11
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY (K131513)Ritm Okb Zao2014-07-11
ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM (K140459)Conmed Corporation2014-07-11
ESIE APPS SUITE (K141554)Siemens Medical Solutions USA, Inc.2014-07-11
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE (K132806)Fotona D.D.2014-07-11
ABX PENTRA MICRO ALB CONTROL L/H (K133676)HORIBA ABX SAS2014-07-11
NEUROPACE BURR HOLE COVER (K141368)NeuroPace, Inc.2014-07-11
INSTAFIX SHAPE MEMORY FIXATION SYSTEM (K141550)Ot Medical2014-07-11
MYLABSIX ULTRASOUND SYSTEM (K141486)Esaote Europe B.V.2014-07-11
REUSABLE GUIDE (K141334)Koelis2014-07-11
VIMOVE (K131094)Dorsa VI Pty., Ltd.2014-07-11
EXPRT REVISION KNEE (K140830)Encore Medical L.P.2014-07-11
EXAMINATION GLOVES (K140316)Hl Rubber Industries Sdn Bhd2014-07-11
THE STORK OTC (K140186)Rinovum Women'S Health, Inc.2014-07-11
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL (K140998)Quality Electrodynamics, LLC2014-07-11
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) (K140451)Keeler Limited2014-07-11
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE (K141558)Surgical Specialties Corp2014-07-11
RANGE/MESA/DENALI SPINAL SYSTEM (K140765)K2m, Inc.2014-07-10
VERADIUS (K133819)Philips Medical Systems Nederland B.V.2014-07-10
GANTRY BEAM LINE (K132919)Ion Beam Applications S.A.2014-07-10
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP (K141027)Implantech Associates, Inc.2014-07-10
MELUNA CLASSIC/SPORT MENSTRUAL CUP (K140626)Meluna2014-07-10
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS (K140101)Ab Medica Sas2014-07-10
BLOSSOM SALINE DELIVERY ASSIST DEVICE (K131692)Marz Medical, Inc.2014-07-10
MARATHON NO STING LIQUID SKIN PROTECTANT (K133443)Advanced Medical Solutions (Plymouth), Ltd.2014-07-10
ENADEN FLOW (K140976)Km Corporation2014-07-10
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES (K140658)Conmed Corporation2014-07-10
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K134005)Intromedic Co., Ltd.2014-07-09
ETEX MIXING AND DELIVERY SYSTEM (K141245)Etex Corporation2014-07-09
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW (K141417)Wrightmedicaltechnologyinc2014-07-09
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM (K140417)Medtronic Sofamor Danek, Inc.2014-07-09
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL (K141444)Siemens Healthcare Diagnostics, Inc.2014-07-09
MERIT SAFETY INTRODUCER NEEDLE (K140513)Merit Medical Systems, Inc.2014-07-09
FLENTS PLASTIC EYE WASH CUP (K140409)Apothecary Products, Inc.2014-07-09
INTRODUCER, MODEL ADELANTE MAGNUM (K140917)Oscor, Inc.2014-07-09
BIOFOAM BONE WEDGE (K140531)Wrightmedicaltechnologyinc2014-07-09
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY (K140643)Depuy Mitek, A Johnson and Johnson Company2014-07-08
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE (K141102)Hospira, Inc.2014-07-08
WIRELESS THERMOMETER (K132761)Raiing Medical Company2014-07-08
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW (K141228)Advanced Orthopaedic Solutions, Inc.2014-07-08
RESTORIS POROUS PARTIAL KNEE SYSTEM (K133811)Mako Surgical Corp.2014-07-08
ARTHREX FRACTURE PLATES AND SCREWS (K141478)Arthrex, Inc.2014-07-08
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K140816)Better Care Plastic Technology Co., Ltd.2014-07-08
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE (K141273)Welldoc, Inc.2014-07-08
BENDA WEDGE (K140144)Centrix, Inc.2014-07-08
CT MIDLINE (K141151)Medcomp (Medical Components, Inc.)2014-07-08
EZ-IO INTRAOSSEOUS INFUSION SYSTEM (K141117)Vidacare, LLC2014-07-08
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS (K141618)Arrow International, Inc (Subsidiary of Teleflex I2014-07-08
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE (K132214)Hager& Meisinger GmbH2014-07-07
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH (K141432)Maquet Cardiopulmonary, AG2014-07-07
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY (K133299)Fresenius Medical Care, North America - Renal Ther2014-07-07
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU (K141051)Arrow International, Inc.2014-07-07
PULSE OXIMETER (K140785)Nonin Medical, Inc.2014-07-07
VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION (K133784)Zimmer Trabecular Metal Technology2014-07-07
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL (K140324)Depuy Mitek, A Johnson and Johnson Company2014-07-07
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE (K131601)Qubyx Limited2014-07-07
SYNGO, CT DUAL ENERGY (K133648)Siemens Medical Solutions USA, Inc.2014-07-07
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL (K132778)Praxair Healthcare Services2014-07-07
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS (K131923)Techlink International2014-07-03
DCAS I (K140869)Gp&P Co., Ltd.2014-07-03
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK (K133689)Pt. Medisafe Technologies2014-07-03
MICROPUNCTURE INTRODUCER SET (K133114)Cook Incorporated2014-07-03
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG (K140902)Biomet, Inc.2014-07-03
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (K140141)Ceragem Medisys, Inc.2014-07-03
NORMED VARIO SUBTALAR SCREW (K140962)Normed Nedizin Technik GmbH2014-07-03
EDWARDS TRANSFEMORAL BALLOON CATHETER (K140241)Edwards Lifesciences, LLC2014-07-03
H&H EMERGENCY CRICOTHYROTOMY KIT (K133528)H & H Medical Corporation2014-07-03
POROUS COATED COMPREHENSIVE FRACTURE STEMS (K140652)Biomet Manufacturing Corp2014-07-03
ASCEND (K140333)Neurometrix, Inc.2014-07-03
COBRA FUNDUS CAMERA (K132987)C.S.O. S.R.L.2014-07-03
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM (K133835)Arthrosurface, Inc.2014-07-03
INFANT INCUBATOR (K132543)Bistos Co., Ltd.2014-07-03
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA (K140641)Boston Scientific Corporation2014-07-03
POD SYSTEM (K141134)Penumbra, Inc.2014-07-03
Z5C (K132881)Z-Systems AG2014-07-03
NAVIO (K140596)Blue Belt Technologies, Inc.2014-07-02
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM (K133110)Boston Scientific Corporation2014-07-02
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K140572)Microlife Intellectual Property GmbH, Switzerland2014-07-02
RS80A DIAGNOSTIC ULTRASOUND SYSTEM (K141620)Samsung Medison Co., Ltd.2014-07-02
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K140121)Andon Health Co, Ltd.2014-07-02
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE (K140055)Titan Spine, LLC2014-07-02
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE (K140512)Juno Dentistry LP2014-07-02
ARROW GPSCATH BALLOON DILATATION CATHETER (K140351)Hotspur Technologies,Inc Subsidiary of Teleflex ME2014-07-02
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER (K140129)Icu Medical, Inc.2014-07-02
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE (K141485)Galil Medical , Ltd.2014-07-02
MCKESSON RADIOLOGY (K140909)Mckesson Medical Imaging Company2014-07-02
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA (K132384)Endosec Corporation2014-07-02
X-REPAIRSL (K141499)Synthasome, Inc.2014-07-02
← Previous Next →

Track 2014 automatically

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