Atlas FDA

2012

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

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RecordFirmDate
ETCH-RITE SUPREME (K120213)Pulpdent Corporation2012-03-30
GE ECHOPAC (K120221)GE Healthcare2012-03-30
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S (K120378)Kuraray Medical, Inc.2012-03-30
ATTUNE SLEEP APNEA SYSTEM (K111549)Apnicure, Inc.2012-03-30
ARISURE NEUTRAL VALVE (K120799)Yukon Medical, LLC2012-03-30
RESPIRATORY HUMIDIFER (K110019)Fisher & Paykel Healthcare, Ltd.2012-03-30
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC (K113168)Ciba Vision Corporation2012-03-30
KITTYCAT CATHETER, KITTYCAT 2 CATHETER (K120273)Avinger, Inc.2012-03-30
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT (K120563)Microphage, Inc.2012-03-30
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT (DEN110002)STERIS Corporation2012-03-30
MCOMPASS ANORECTAL MANOMETRY SYSTEM (K120088)Medspira, LLC2012-03-29
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K112538)Alfa Wassermann Diagnostic Technologies, Inc.2012-03-29
TIGER SPINE SYSTEM (K113058)Corelink, LLC2012-03-29
INFRARED EAR THEROMETER (K111703)Fudakang Industrial Co., Ltd.2012-03-29
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K113327)Stryker Corp.2012-03-29
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM (K120738)Ostial Corporation2012-03-29
LOCKING COMPRESSION PLATE SYSTEM (K112798)Shanghai Microport Orthopedics Co., Ltd.2012-03-29
INFANT ARRAY (K113365)Advanced Imaging Research Dba Sree Medical Systems2012-03-29
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS (K112702)Imperial Surgical , Ltd.2012-03-29
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN (K112863)Acta Medical, LLC2012-03-29
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 (K120616)Spacelabs Medical, Inc.2012-03-29
IMAGER II ANGIOGRAPHIC CATHETERS (K120893)Boston Scientific Corp2012-03-29
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206)Medtronic Minimed2012-03-29
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 (K110737)Bionime Corporation2012-03-29
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM (K113233)Shen Wei (Usa), Inc.2012-03-29
ACDS (K120005)Isopure, Corp.2012-03-29
ACCOLADE II HIP STEM (K120578)Howmedica Osteonics2012-03-29
TOSHIBA 1.5T QD HEAD COIL (K120627)Quality Electrodynamics2012-03-29
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM (K120568)Abbott Diabetes Care, Inc.2012-03-29
VPAP ST-A (K113288)Resmed, Ltd.2012-03-29
AQUASHIELD CO2 SYSTEM (K120123)United States Endoscopy Group, Inc.2012-03-28
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES (K112834)Verichem Laboratories, Inc.2012-03-28
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR (K112948)Jiangsu Healthy Way Medical Equipment Co;Ltd2012-03-28
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR (K112950)Jiangsu Healthy Medical Equipment Co;Ltd2012-03-28
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM (K113243)Eps Bio Technology Corp.2012-03-28
SMARTPILOT VIEW MODEL MK04500 (K103035)Draeger Medical GmbH2012-03-28
CRAG LATERAL FLOW ASSAY (LFA) (K112422)Immuno-Mycologics, Inc.2012-03-28
FOTONA XP ND: YAG LASER SYSTEM (K113702)Fotona D.D.2012-03-28
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL (K113547)Apex BioTechnology Corp.2012-03-28
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) (K110587)Bayer Healthcare, LLC2012-03-28
ELLIPSE PRECICE TRAUMA NAIL SYSTEM (K113695)Ellipse Technologies, Inc.2012-03-28
REXIOUS HOOK FIXATION SYSTEMS (K113324)Dio Medical Co., Ltd.2012-03-28
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (K110894)Bayer Healthcare2012-03-28
ZAVATION IBF SYSTEM (K120576)Zavation, LLC2012-03-28
AZUR DETACHABLE 18 (K120630)MicroVention, Inc.2012-03-28
RESIGLASS PASTE (K112307)Shofu Dental Corporation2012-03-28
BD RECYKLEEN SHARPS COLLECTORS (K112774)Becton, Dickinson and Company2012-03-28
ONE PERSONAL LUBRICANT (SILICONE) (K110690)One2012-03-28
VISIA ONCOLOGY (K120484)MeVis Medical Solutions AG2012-03-27
ZIMMER PERSONA KNEE SYSTEM (K113369)Zimmer, Inc.2012-03-27
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977)Alcon Research, Ltd.2012-03-27
WOUND PROTECTOR (K120061)Covidien, Formerly US Surgical A Divison of Tyco H2012-03-27
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K113672)VATECH Co., Ltd.2012-03-27
INSULATION TESTER (K120416)Spectrum Surgical Supply Corp.2012-03-27
RESSCAN (K113815)Resmed, Ltd.2012-03-27
ANESTHESIA INJECTION TOOL SET (K113247)Ki Works Co., Ltd.2012-03-27
INDEPENDENCE SPACER (K120101)Globus Medical, Inc.2012-03-27
MULTIFIX P KNOTLESS FIXATION DEVICE (K120096)ArthroCare Corporation2012-03-27
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK (K120504)Bio-Rad Laboratories, Inc.2012-03-27
BRIVO MR355 (K120778)Ge Hangwei Medical Systems Co., Ltd.2012-03-27
SURGICASE GUIDE (K111558)Materialise NV2012-03-27
ABACUS 5 (K112755)Diatron U.S., Inc.2012-03-27
VENUS SPINAL FIXATION SYSTEM (K120270)L&K BIOMED Co., Ltd.2012-03-26
BIOPLEX 2200 TORC IGG (K120572)Bio-Rad Laboratories, Inc.2012-03-26
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION (K110535)Carefusion 303, Inc.2012-03-26
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX (K113866)Brennen Medical, LLC2012-03-23
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K120049)Becton, Dickinson and Company2012-03-23
I-LIPO SYSTEM (K111501)Chromogenex Technologies Limited2012-03-23
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) (K113748)Imris, Inc.2012-03-23
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM (K112469)Sonowand AS2012-03-23
SPECULUM, VAGINAL, NONMETAL (K120743)Welch Allyn, Inc.2012-03-23
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX (K113733)Neoortho Produtos Ortopedicos S/A2012-03-23
PALLS M SPINAL SYSTEM (K120538)Korea Bone Bank Co., Ltd.2012-03-23
RESORB X-G (K112064)KLS-Martin L.P.2012-03-23
BLADDER SCANNER (K113304)MEDA Co., Ltd.2012-03-23
APACERAM BONE GRAFT SUBSTITUTE (K120602)Hoya Corporation2012-03-23
BIOLIS 12I (K110520)Tokyo Boeki Medisys, Inc.2012-03-23
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP (K103704)Zephyr Sleep Technologies, Inc.2012-03-23
MYOSURE CONTROL UNIT (K120593)Hologic, Inc.2012-03-23
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER (K112377)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-03-23
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET (K113798)Draeger Medical Systems, Inc.2012-03-22
SPACELABS ARKON ANESTHESIA WORKSTATION (K113051)Spacelabs Healthcare2012-03-22
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE (K111702)Fenwal, Inc.2012-03-22
PHYSIOLOGICAL MONITOR, PATIENT MONITOR (K113441)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2012-03-22
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K113220)Boston Scientific Corporation2012-03-22
EZSLEEP SLEEP QUALITY RECORDER (K112573)Platinum Team Co., Ltd.2012-03-22
VISI MOBILE MONITORING SYSTEM (K112478)Sotera Wireless, Inc.2012-03-22
GENII GI 4000 ELECTROSUGICAL GENERATOR (K113265)Genii, Inc.2012-03-22
INTELLIVUE PATIENT MONITOR (K113657)Philips Medizin Systeme Boblingen GmbH2012-03-22
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX (K113117)Nihon Kohden America, Inc.2012-03-22
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K112005)Ug Healthcare (Usa), Inc.2012-03-21
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM (K102900)Hei, Inc.2012-03-21
ZOLL X SERIES (K112432)Zoll Medical Corporation, World Wide Headquarters2012-03-21
PULTOL (K113865)Sharp Corporation2012-03-21
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070)Synthes USA2012-03-21
UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR (K112887)Upstream Peripheral Technologies2012-03-21
POSEY BED (K113357)J. T. Posey Co.2012-03-21
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES (K112012)Ug Healthcare (Usa), Inc.2012-03-21
INTRAUTERINE INSEMINATION (IUI) CATHETER (K120154)Catheter Research, Inc.2012-03-21
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (K113818)Pulpdent Corporation2012-03-21
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