Atlas FDA

2011

3,124 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM (K094035)Stelkast Company2011-03-24
MOBILEECG SYSTEM (K103427)Memtec Corp.2011-03-24
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K102465)Respironics, Inc.2011-03-24
BODYTOM NL 4000 (K102677)Neurologica Corporation2011-03-24
MANUKATEX (K110042)Manuka Medical Limited2011-03-24
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA (K103837)Ortho Development2011-03-24
ARCOMXL ACTIVE ARTICULATION (K110555)Biomet Manufacturing Corp2011-03-24
THERMO SCIENTIFIC MAS R DOA TOTAL (K103656)Microgenics Corporation2011-03-24
ABL835 FLEX ANALYZER WITH PLEURAL PH (K110416)Radiometer Medical Aps2011-03-24
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (K101852)Iris International Inc., A Division of Iris Iris I2011-03-23
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW (K110552)Wrightmedicaltechnologyinc2011-03-23
VENTRALEX ST HERNIA PATCH (K101928)C.R. Bard, Inc.2011-03-23
QUANTA FLASH H-TTG IGG (K101644)Inova Diagnostics, Inc.2011-03-23
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT (K102241)Anthogyr Sas2011-03-23
PIONEER SPINAL PROCESS FUSION PLATE (K110367)Pioneer Surgical Technology, Inc.2011-03-23
CELSTAT (K103245)Baxter Healthcare Corp2011-03-23
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM (K103650)Oon Corp. Resources2011-03-23
FORZA SPACER SYSTEM (K103111)Orthofix, Inc.2011-03-23
LANX LATERAL (K103666)Lanx, Inc.2011-03-23
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE (K103661)Rubbercare Protection Products Sdn Bhd2011-03-23
SIMMETRY SACROILIAC JOINT FUSION SYSTEM (K110512)Zyga Technology, Inc.2011-03-23
VENTRIO ST HERNIA PATCH (K101920)C.R. Bard, Inc.2011-03-23
ROTATING GAMMA SYSTEM INFINI (INFINI) (K102533)Masep Medical Science & Tech.Development (Shenzhen2011-03-22
SOPRO 281 (K103813)Sopro2011-03-22
MUSTANG BALLOON DILATATION CATHETERS (K103751)Boston Scientific2011-03-22
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K101422)Access Scientific, Inc.2011-03-22
JTS EXTENDEABLE IMPLANT (K092138)Stanmore Implants Worldwide , Ltd.2011-03-22
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T (K110151)Philips Health Care2011-03-22
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES (K093046)Synvasive Technology, Inc.2011-03-22
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES (K103696)Erbe USA, Inc.2011-03-22
APOLONIA LASER IMPLANT SYSTEM (K102635)Csm Implant Co., Ltd.2011-03-22
CONFIDENT SURGERY SUITE 300, MODEL CSS300 (K101887)Surgiceye GmbH2011-03-22
LIFEPAK 15 MONITOR/DEFIBRILLATOR (K103567)Physio-Control, Inc.2011-03-22
MIDMARK IQECG (K103640)Brentwood Medical Technology Corp.2011-03-22
IDEAL IQ SOFTWARE OPTION (K103411)GE Medical Systems2011-03-22
ORTHOPHOS XG 3D / CEPH (K103711)Sirona Dental Systems GmbH2011-03-22
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES (K110299)Grandway Technology (Shenzhen) Limited2011-03-21
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS (K100424)Danmedical Limited2011-03-21
HEM-4030 (K110501)Omron Healthcare, Inc.2011-03-21
MPACT ACETABULAR SYSTEM (K103721)Medacta International2011-03-21
LOW PROFILE SCREWS (K103705)Arthrex, Inc.2011-03-18
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE (K103136)Materialise NV2011-03-18
SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE (K110224)Weifang Beihai Color Printing Packagging Co., Ltd.2011-03-18
AXSOS (TM) LOCKING PLATE SYSTEM (K110476)Stryker Corp.2011-03-18
PHILIPS AVALON FETAL MONITOR (K102958)Philips Medizin Systeme Boblingen GmbH2011-03-18
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM (K110064)Snap Diagnostics, LLC2011-03-18
JOULE MULTI-PLATFORM SYSTEM (K101916)Sciton, Inc2011-03-18
EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C (K102779)Siemens Healthcare Diagnostics, Inc.2011-03-18
S9 VPAP ADAPT WITH H5I (K102586)Resmed, Ltd.2011-03-18
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS (K110482)Teratech Corp.2011-03-18
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS (K103798)Becton, Dickinson & CO2011-03-18
INTRA SKAN DC (K103579)Skanray Technologies2011-03-18
CPR FACE MASK (K102299)Genuine First Aid, LLC2011-03-18
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE (K102588)Medtronic Ablation Frontiers, LLC2011-03-18
SENTINELLA 102 (K110601)General Equipment For Medical Imaging, S.A.2011-03-18
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 (K101792)Linde Gas North America, LLC2011-03-18
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE (K110553)Asahi Intecc USA, Inc.2011-03-18
ACCELL EVO3 (FORMERLY ACCELL A2I) (K103742)Integra Life Sciences2011-03-17
EVEREST SPINAL SYSTEM (K103440)K2m, Inc.2011-03-17
AYCAN WORKSTATION OSIRIX PRO (K103546)Aycan Digitalsysteme GmbH2011-03-17
REVERE SACRAL PLATES (K103072)Globus Medical, Inc.2011-03-17
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY (K110371)Panoramic Corp.2011-03-17
MASIMO RADICAL Y PULSE CO-OXIMETER (K110028)Masimo Corporation2011-03-17
PRIMUS AESTHETIC PLATFORM (K103664)Palomar Medical Technologies, Inc.2011-03-17
FLEXFUSION (TM) FIXATION IMPLANT (K110445)Nextremity Solutions, LLC2011-03-17
HEMOSIL PROTEIN S ACTIVITY ASSAY (K102164)Instrumentation Laboratory CO2011-03-17
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (K103416)Infimed, Inc.2011-03-17
PLANMECA PROMAX 3D MID (K103689)Planmeca Oy2011-03-17
CONCORDE CURVE SYSTEM (K103743)Johnson & Johnson2011-03-17
PEZO INTERBODY CAGES SYSTEM (K103814)Ulrich GmbH & Co. KG2011-03-17
WINSTIM (K102190)Johari Digital Healthcare , Ltd.2011-03-17
PATIENT EXAMINATION GLOVES (K102846)Thai Hua Holding Co., Ltd.2011-03-17
PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL (K103375)Medtek Devices, Inc.2011-03-16
IVD-GE02 (K101947)Sphere Medical , Ltd.2011-03-16
AAXTER A3 POSTERIOR SPINAL SYSTEM (K101374)Aaxter Co., Ltd.2011-03-16
ESCALADE ACETABULAR CUP SYSTEM (K103384)Ortho Development2011-03-16
ZENOFLEX DIMENSION (K103773)Wieland Dental + Technik GmbH & Co. KG2011-03-16
MODALIXX (K110108)Ampronix, Inc.2011-03-16
DOPPLER MONITOR (K110347)Cook Vascular, Inc.2011-03-16
IPLAN RT (K103246)Brainlab AG2011-03-16
BACKSTOP CATHETER (K110491)Pluromed, Inc.2011-03-16
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K103720)Fujifilm Medical Systems U.S.A, Inc.2011-03-16
IDS-ISYS IFG-I CONTROL SET (K110412)Immunodiagnostic Systems , Ltd.2011-03-16
GETINGE 400HC/500HC SERIES STEAM STERILIZER (K103504)Getinge Sourcing, LLC2011-03-16
RELIANCE ENDOSCOPE PROCESSING SYSTEM (K110453)STERIS Corporation2011-03-16
MIRAGE MICRO (K110444)Resmed, Ltd.2011-03-16
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY (K102727)Lensar, Inc.2011-03-16
NHANES WHOLE BODY DXA REFERENCE DATABASE (K103265)Hologic, Inc.2011-03-16
SINGLE CANNULA EXTENDED APPLICATOR (K102563)Micromedics, Inc.2011-03-15
SPIDER STANDARD AND ADVANCED (K102839)Transenterix, Inc.2011-03-15
ALTUM ANTERIOR CERVICAL PLATE (K103505)Spinecraft, LLC2011-03-15
ESSENTIAL MRI PATIENT MONITOR (K103700)Invivo Corporation2011-03-15
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K110018)Andon Health Co, Ltd.2011-03-15
STAR 50 N (K103686)Larsen & Toubro Limited2011-03-15
DEPUY ATTUNE TOTAL KNEE SYSTEM (K103756)DePuy Orthopaedics, Inc.2011-03-15
MEMOMETAL NAVIS BONE PLATING SYSTEM (K101930)Memometal Technologies2011-03-15
ALLERGEAZE R CLEAR (K103409)Smartpractice2011-03-15
BELIMED STEAM STERILIZER MST-V (K103841)Sauter AG2011-03-15
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM (K103404)Zimmer GmbH2011-03-15
UBM PLUS (K103471)Accutome, Inc.2011-03-14
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Every clearance here is in the API, with alerts when new ones post.