Atlas FDA

2012

3,135 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SONY LMD-2451MT LCD MONITOR (K113203)Sony Electronics, Inc.2012-02-24
Q. FREEZE (MOTION VUE2) (K113408)Ge Medical Systems, LLC2012-02-24
LINEAR HIP STEM, SIZE 5 (K120241)Encore Medical L.P.2012-02-24
14 WIRE STANDARD, 14 WIRE LS (K113454)Micro Therapeutics, Inc.2012-02-24
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) (K113587)Shantou Wealy Medical Instrument Co.,Ltd2012-02-24
ENVOY DISTAL ACCESS GUIDING CATHETER (K120229)Codman & Shurtleff, Inc.2012-02-24
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (K120314)Welldoc, Inc.2012-02-24
Q50 PLUS STENT GRAFT BALLOON CATHETER (K120381)Qxmedical, LLC2012-02-24
CONNEX WORKSTATION (K120343)Welch Allyn, Inc.2012-02-24
SITESCRUB IPA DEVICE (K112791)C. R. Bard2012-02-24
SOL-M EXCHANGEABLE NEEDLES (K112777)Sol-Milennium Medical, Inc.2012-02-24
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM (K112861)Sintea Plustek, LLC2012-02-24
MEDIGUIDE TECHNOLOGY (K120301)St. Jude Medical, Mediguide Navigation Systems2012-02-24
BLUESHINE'S GOLD SERIES (K110375)Blueshine Srl2012-02-23
UPSTREAM SUPPORT CATHETER (K112886)Upstream Peripheral Technologies2012-02-23
PROULTRA PIEZO ULTRASONIC (K113430)Satelec - Acteon Group2012-02-23
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE (K113222)Nakamura Dental Handpiece Mfg. Co., Ltd.2012-02-23
PILAIRO NASAL PILLOWS MASK (K120027)Fisher & Paykel Healthcare Limited2012-02-23
COLLAGEN RIBBON (K120019)Wrightmedicaltechnologyinc2012-02-23
SUREFIRE GUIDE SHEATH (K113737)Surefire Medical, Inc.2012-02-23
FIXATE TISSUE BAND (K113805)Anulex Technologies, Inc.2012-02-23
KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 (K112758)Kat Implants, LLC2012-02-23
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (K111970)Tornier2012-02-23
INVENDO C20 COLONOSCOPY SYSTEM (K100624)Invendo Medical Gbmh2012-02-23
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP (K113570)Integra Burlington Ma, Inc.2012-02-22
ASPIRE MAX ASPIRATION CATHETER (K113757)Control Medical Technology, LLC2012-02-22
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM (K112679)Materialise Dental NV2012-02-22
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K111755)Ventana Medical Systems, Inc.2012-02-22
SMARTHEART (K113514)Shl Telemedicine International , Ltd.2012-02-22
RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS (K113065)Bella Elevator, LLC2012-02-22
LEFORTE NEURO SYSTEM BONE PLATE (K112812)Jeil Medical Corporation2012-02-22
SPECTRA LASER SYSTEM (K113588)Lutronic Corporation2012-02-22
BONETRAP (K120189)Berni Farns Incorporated2012-02-22
INCONTROL (K110179)Incontrol Medical, LLC2012-02-22
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K113520)STERIS Corporation2012-02-21
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR (K111141)Wenzhou Bokang Instruments Co., Ltd.2012-02-21
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM (K120321)Philips Health Care2012-02-17
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM (K120163)Acute Innovations, LLC2012-02-17
VALEO VT-601 SERIES IR THERMOMETER (K111463)Valeo Corp.2012-02-17
SIRONA DENTAL CAD/CAM SYSTEM (K111421)Sirona Dental Systems GmbH2012-02-17
ACE STAPLER AND CARTRIDGE (K120147)Barosense, Inc.2012-02-17
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY (K113627)Orthocon2012-02-17
EQUIVITAL (K113054)Hidalgo Limited2012-02-17
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER (K113505)Greiner Bio-One North America, Inc.2012-02-17
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET (K120272)Kentec Medical, Inc.2012-02-17
CLOSER TO NATURE ELECTRIC BREAST PUMP (K113664)Mayborn Group Limited2012-02-17
GEODESIC EEG MOBILE 100 (GEM 100) (K112353)Electrical Geodesics, Inc.2012-02-17
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT (K111935)Nt-Trading GmbH and CO KG2012-02-17
NANOBLUTM 500 (K113206)Draeger Medical Systems, Inc.2012-02-17
POWDERFREE POLYISOPRENE SURGICAL GLOVES (K112654)Pt. Medisafe Technologies2012-02-17
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS (K120081)Cincinnati Sub-Zero Products, Inc.2012-02-17
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN (K111976)bioMerieux, Inc.2012-02-17
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM (K113452)Ascendx Spine, Inc.2012-02-17
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) (K112781)Luminex Molecular Diagnostics, Inc.2012-02-17
WAGNER CONE PROSTHESIS SYSTEM (K113556)Zimmer GmbH2012-02-17
ARTHREX KNOTLESS SUTURETAK ANCHOR (K120155)Arthrex, Inc.2012-02-17
ICON (TM) MODULAR PEDICLE SCREW SYSTEM (K111448)Orthofix, Inc.2012-02-16
EVIS EXERA III VIDEO SYSTEM (K112680)Olympus Medical Systems Corporation2012-02-16
SURFACE BEACON TRANSPONDERS (K112841)Calypso Medical Technologies, Inc.2012-02-16
PLEURX PLEURAL CATHETER SYSTEMS (K112831)Care Fusion2012-02-16
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM (K113526)Medos International SARL2012-02-16
CS IMAGING (K113419)Trophy2012-02-16
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K113518)Spinefrontier, Inc.2012-02-16
3DI (K113442)Shina Systems , Ltd.2012-02-16
I-PORT ADVANCE INJECTION PORT (K120337)Unomedical A/S2012-02-16
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES (K110825)Philips Medical Systems2012-02-16
KOWA VX-20 (K112330)Kowa Co. , Ltd.2012-02-16
EAUM TOTAL KNEE SYSTEM (K110404)Corentec Co., Ltd.2012-02-16
CHROMOPHARE F 628 AND F 528 (K120392)Berchtold GmbH & Co. KG2012-02-16
BD MAX GBS ASSAY, BD MAX INSTRUMENT (K111860)Becton, Dickinson & CO2012-02-16
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL (K120143)Apollo Spine2012-02-16
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE (K120121)Biomet, Inc.2012-02-16
STLASE (K111689)Dental Photonics, Inc.2012-02-16
3B WILLOW (K112271)3B Products, LLC2012-02-16
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR (K111473)Impact Instrumentation, Inc.2012-02-16
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS (K111874)Abbott Laboratories2012-02-16
WAVES (K111521)Waters Medical Systems, LLC2012-02-16
VISIA NEURO (K113701)MeVis Medical Solutions AG2012-02-16
OLYMPUS INSTRUMENT TRAY (K110748)Olympus Winter & Ibe GmbH2012-02-15
TEPHAFLEX LIGHT MESH (K113721)Tepha, Inc.2012-02-15
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL (K113409)Howmedica Osteonics Corp.2012-02-15
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 (K110278)Nakanishi, Inc.2012-02-15
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K113378)Conformis, Inc.2012-02-15
ELECTROPULSE-COSMETIC (K113724)Pain Relief Technologies2012-02-15
FOCUS SPINAL SYSTEM (K120140)L&K BIOMED Co., Ltd.2012-02-15
TEPHAFLEX MESH (K113723)Tepha, Inc.2012-02-15
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE (DEN120001)Phadia US, Inc.2012-02-15
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... (K111938)Immunodiagnostic Systems , Ltd.2012-02-14
CADENS (TM) COLON (K111758)Dog Microsystems, Inc.2012-02-14
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE (K113634)Cook Ireland, Ltd.2012-02-14
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (K113496)Coloplast A/S2012-02-14
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM (K113403)GE Medical Systems SCS2012-02-14
VICTORY GUIDEWIRE (32 MODELS) (K120137)Brivant, Ltd.2012-02-14
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) (K113390)Meridian AG2012-02-14
ESOPHAGEAL TTS STENT (K113551)Taewoong Medical Co., Ltd.2012-02-14
POLYFUSE - NEUROBONE (K111018)Atpac Medical, LLC2012-02-14
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR (K113710)Full Synergy Medical Products, Inc.2012-02-14
VITAL SIGNS MONITOR (K120144)Edan Instruments, Inc.2012-02-14
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR (K120132)Philips Medical Systems2012-02-14
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR (K113722)Full Synergy Medical Products, Inc.2012-02-14
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Every clearance here is in the API, with alerts when new ones post.