Atlas FDA

2012

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

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RecordFirmDate
MICROFRANCE(R) WORMALD VASCULAR CLAMP (K112662)Medtronic Xomed, Inc.2012-01-20
LEXUS ANTERIOR CERVICAL PLATE SYSTEM (K113509)L&K BIOMED Co., Ltd.2012-01-20
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS (K113302)North American Science Assoc., Inc.2012-01-20
SPECTRA OPTIA APHERESIS SYSTEM (K113480)Caridianbct, Inc..2012-01-20
RELIANCE SPINAL SCREW SYSTEM (K110896)Reliance Medical Systems, LLC2012-01-20
REGENEROSS ALLOGRAFT PLUS MINERLIZED (K113645)Biomet Interpore Cross2012-01-20
DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. (K112161)Radiometer Medical Aps2012-01-20
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE (K113709)Biolitec Medical Devices, Inc.2012-01-20
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR (K113294)Smith & Nephew, Inc.2012-01-20
OPTICAGE INTERBODY FUSION DEVICE (K113527)Interventional Spine, Inc.2012-01-20
TORQTECH (K103697)J. Morita USA, Inc.2012-01-20
CELLTRACKS AUTOPREP SYSTEM (K110406)Veridex, LLC2012-01-20
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (K112343)Siemens Healthcare Diagnostics, Inc.2012-01-20
GPSCATH BALLON DILATATION CATHETER (K113769)Hotspur Technologies2012-01-20
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (K111157)Carl Zeiss Meditec, Inc.2012-01-19
OASYS SPINAL SYSTEM (K111719)Stryker Spine2012-01-19
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR (K113083)Truly Instrument Co., Ltd.2012-01-19
NANOVIS SPINAL SYSTEM (K113173)Nanovis, LLC2012-01-19
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) (K120010)Shenzhen Med-Link Electronics Tech Co., Ltd.2012-01-19
RS-4I MUSCLE STIMULATOR (K112348)Rs Medical2012-01-19
HISTOBRUSH (K111681)Puritan Medical Products Company, LLC2012-01-19
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE (K113792)Biolitec Medical Devices, Inc.2012-01-19
KIMGUARD SMART-FOLD* STERILIZATION WRAP (K112300)Kimberly-Clark Corp.2012-01-19
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX (K112868)Dreamgard, Inc.2012-01-19
HANDHELD PULSE OXIMETER (K111494)Beijing Choice Electronic Technololgy Co., Ltd.2012-01-18
MISSION U500 URINE ANALYZER (K111221)ACON Laboratories, Inc.2012-01-18
AVITA ARM TYPE BLOOD PRESSURE MONITOR (K112825)Avita Corporation2012-01-18
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (K111407)Advanced Surgical Concepts2012-01-18
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (K112612)Top Calibre Sdn Bhd2012-01-18
AG-608N BLOOD GLUCOSE MONITORING SYSTEM (K110017)Andon Medical Co., Ltd.2012-01-18
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL (K113773)St Jude Medical2012-01-18
QUASAR CALYPSO (K111286)Silver Bay, LLC2012-01-18
CUFFINK (K112814)Cayenne Medical, Inc.2012-01-17
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS (K113730)Parcus Medical, LLC2012-01-17
K2M, PYRENEES CERVICAL PLATE SYSTEM (K113329)K2m, Inc.2012-01-17
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM (K113366)Phygen, LLC2012-01-17
PEEK PREVAIL CERVICAL INTERBODY DEVICE (K113252)Medtronic Sofamor Danek2012-01-17
AERODR SYSTEM WITH P-21 (K113248)Konica Minolta Medical & Graphic, Inc.2012-01-17
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM (K112441)Daesung Maref Co., Ltd.2012-01-17
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III (K113098)Apex BioTechnology Corp.2012-01-17
OSTEON II (K112716)Genoss Co., Ltd.2012-01-17
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL (K113101)Boston Scientific Corporation2012-01-17
HYPERION (K113497)Cefla S.C. Cefla Dental Group2012-01-17
VANTAGE TITAN 3T (K113093)Toshibamedical Systems Corporation2012-01-13
ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION (K112730)Biomet 3i2012-01-13
HEISENBERG EFFECT SHADES (K120011)3M Espe AG2012-01-13
THERMO PAL INFRARED EAR THERMOMETER (K112189)Digio2 International Co., Ltd.2012-01-13
THE VENOUS ASSIST SYSTEM (K112677)Daesung Maref Co., Ltd.2012-01-13
V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE (K110083)Respironics California, Inc.2012-01-13
ACQA (K113086)Texas Medical Imaging Consultants2012-01-13
ENDOEYE HD II (K111788)Olympus America, Inc.2012-01-13
BABI PLUS NEONATAL RESUSCITATION BAG (K112852)A Plus Medical2012-01-13
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER (K112013)Biolitec, Inc.2012-01-13
PDE PHOTODYNAMIC EYE (K110480)Hamamatsu Photonics K.K.2012-01-13
MEDI-SIS SYRINGE INFUSION SYSTEM (K111381)Acacia, Inc.2012-01-13
OPTIMA MR450W (K113490)Ge Medical Systems, LLC2012-01-13
SCEPTER XC OCCLUSION BALLOON CATHETER (K113698)MicroVention, Inc.2012-01-13
SLIM ONEBODY SYSTEM (K111162)Dentium Co., Ltd.2012-01-13
VARIOUS (K112417)Depuy Mitek, A Johnson & Johnson Company2012-01-13
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL (K112727)Medical Facets2012-01-13
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT (K113410)Straumann USA2012-01-13
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 (K112114)Maquet Critical Care AB2012-01-13
CRY-ACTRACKERCAM (K110305)Brymill Cryogenic Cystems2012-01-13
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM (K112707)Ortho Technology, Inc.2012-01-13
ABSOLUTE WHITE LIGHT (K110888)Dr. Fresh, Inc.2012-01-12
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL (K113683)Hospira, Inc.2012-01-12
FUNNEL GUIDE CATHETER MODEL G1020608 (K102439)Lazarus Effect, Inc.2012-01-12
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM (K113123)The Orthopaedic Implant Company2012-01-12
CASPIAN (K113654)K2m, Inc.2012-01-12
LUCEA LED SURGICAL LIGHT SYSTEM (K113679)Maquet S.A.S.2012-01-12
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION (K100437)Bestgen Biotech Corp.2012-01-12
CABLECAP (K113330)Sensormed2012-01-12
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED (K113699)The Procter & Gamble Company2012-01-12
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM (K113318)Acute Innovations, LLC2012-01-12
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR (K113085)Truly Instrument Co., Ltd.2012-01-12
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING (K113667)Edwards Lifesciences, LLC2012-01-12
CUROS PORT PROTECTOR (K111992)Ivera Medical, Inc.2012-01-12
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY (K113069)Biomet Manufacturing Corp2012-01-11
SYNERGY TISSUE MATRIX (K113460)Synovis Orthopedic & Woundcare2012-01-11
GLADIATOR PTA BALLOON DILATION CATHETER (K113681)Boston Scientific2012-01-11
STERIS STEAM PI (K112256)STERIS Corporation2012-01-11
SANICLAVE 200 (K112811)Alternative Pioneering Research and Development2012-01-11
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K113651)Boston Scientific Corporation2012-01-11
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM (K113405)Suspension Orthopaedic Solutions, LLC2012-01-11
REPROCESSED HARMONIC SCALPEL (K111794)Sterilmed, Inc.2012-01-11
CORTRAK ENTERAL ACCESS DEVICE (K113351)Corpak Medsystems2012-01-10
PREPEX SYSTEM (K103695)Circ Medtech2012-01-10
PROPATCH SOFT TISSUE REPAIR MATRIX (K110581)Cryolife, Inc.2012-01-10
NEO TITANIUM MESH, CTI-MEM (K111761)Neobiotech Co., Ltd.2012-01-10
FINE JECT INSULIN PEN NEEDLE (K112332)Twobiens Co., Ltd.2012-01-10
DSS STABILIZATION SYSTEM (K113625)Paradigm Spine, LLC2012-01-10
TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT (K110971)Navotek Medical, Ltd.2012-01-10
ALEUTIAN SYSTEM (K113138)K2m, Inc.2012-01-10
VOLUSON E6/E8/E8EXPERT/E10 (K113758)GE Healthcare2012-01-10
I-ENDO DUAL (K111623)Satelec - Acteon Group2012-01-10
APNEA RISK EVALUATION SYSTEM (ARES) (K112514)Advanced Brain Monitoring, Inc.2012-01-09
NEUROTECH PLUS (K112258)Bio-Medical Research, Ltd.2012-01-09
SYNTHECEL DURA REPLACEMENT DEVICES (K113071)Synthes2012-01-09
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE (K112960)Cayenne Medical, Inc.2012-01-09
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