Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT (K093831)Health & Life Co., Ltd.2010-03-25
MULTIPLE PRIVATE LABEL (K100162)Biogreen Yields Sdn.Bhd2010-03-24
INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE (K093808)Incite Innovation, LLC2010-03-24
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100326)Tangshan Hongda Plastci Products Co, Ltd.2010-03-24
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO (K100317)VATECH Co., Ltd.2010-03-24
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY (K092046)Berkeley Advanced Biomaterials, Inc.2010-03-24
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM (K100186)Medison Co., Ltd.2010-03-24
BONASTENT BILIARY (K093003)Endochoice, Inc.2010-03-24
GYNCARE MORCELLEX TISSUE MORCELLATOR (K100280)ETHICON, Inc.2010-03-24
XRES BLOOD COLLECTION RESERVOIR (K100507)Sorin Group Italia S.R.L.2010-03-24
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT (K091890)Healthpoint, Ltd.2010-03-24
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 (K093984)Time Medical Limited2010-03-24
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP (K100385)Luv N' Care, Ltd.2010-03-24
EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE (K090364)Angioslide, Ltd.2010-03-23
OPAL BOND MV (K094006)Ultradent Products, Inc.2010-03-23
SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT (K094044)Tayside Flow Technologies Limited2010-03-23
ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K083842)Pentapharm GmbH2010-03-23
D-STORM 810NM, D-STORM 980NM (K093048)Light Instruments2010-03-23
HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 (K093946)Hoveround Corp.2010-03-22
18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR (K094047)Modern Rehabilitation Solutions Co., Ltd.2010-03-22
HEARTWAY POWER CHAIR, P23 (K100327)Heartway Medical Products Co., Ltd.2010-03-22
GORE DRYSEAL SHEATH (K093791)W. L. Gore & Associates, Inc.2010-03-22
BELRAY II (K093240)Takara Belmont Corp.2010-03-22
SYSTEMS INTEGRATION MODEL: ENDOALPHA (K100345)Olympus Medical Systems Corporation2010-03-22
VPAP III ST-A (K093731)Resmed, Ltd.2010-03-22
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT (K100350)Hoveround Corp.2010-03-22
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100339)Tangshan Changrong Glove Co., Ltd.2010-03-22
KNEEALIGN SYSTEM WITH REFERENCE SENSOR (K093998)Orthalign, Inc.2010-03-22
LAPORT (K092584)Mgb Endoskopische Gerate GmbH (Berlin)2010-03-22
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY (K100303)Angioscore, Inc.2010-03-22
AUTOLOG AUTOTRANSFUSION SYSTEM (K093535)Medtronic, Inc.2010-03-22
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 (K093732)Siemens Healthcare Diagnostics2010-03-22
ELECSYS TROPONIN T CALCHECK 5 (K092848)Roche Diagnostics Corp.2010-03-19
REPROCESSED TROCARS, MODEL B5LT AND CB5LT (K100080)Ascent Healthcare Solutions2010-03-19
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 (K093115)Kimberly-Clark Corp.2010-03-19
NBM-200MP PULSE OXIMETRY DEVICE (K091564)Orsense, Ltd.2010-03-19
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 (K100293)Siemens Heatlhcare Diagnostics, Inc.2010-03-19
OPUS SPEEDSCREW SYSTEM (K100457)Arthrocare Corp.2010-03-19
SMPLE PLATE AND SCREWS (K093983)Biomet Trauma (Aka Ebi, Lp)2010-03-19
MEDPOR CONTAIN IMPLANT (K091120)Porex Surgical, Inc.2010-03-19
SLIT LAMP BO 900, BQ 900, BP900 (K100202)Haag-Streit AG2010-03-19
ESTHETICA (K100083)Kerr Corporation2010-03-19
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR (K093492)Diamond Diagnostics, Inc.2010-03-19
ARTHREX TIBIAL GRAFTBOLT (K093912)Arthrex, Inc.2010-03-18
TINA-QUANT CERULOPLASMIN (K091741)Roche Diagnostics2010-03-18
IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS (K093419)Stryker Instruments, Instruments Div.2010-03-18
COAGUCHEK XS PRO SYSTEM (K093460)Roche Diagnostics2010-03-18
MODIFICATION TO: OASYS SYSTEM (K093670)Stryker Spine2010-03-18
BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 (K092149)Bovie Medical2010-03-18
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H) (K100226)Rio Flexon Technology Co., Ltd.2010-03-18
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, (K093957)Fujirebio Diagnostics,Inc.2010-03-18
STORM-BASE 2.0 (K093603)KARL STORZ Endoscopy-America, Inc.2010-03-18
ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW (K091631)Aspyra, Inc.2010-03-18
SEC IBF CAGE (K093669)Innvotec Surgical, Inc.2010-03-18
CP-FIBER (ORTHOFIBER) (K094028)Cp Medical2010-03-18
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (K092699)Neurotronics, Inc.2010-03-18
DIGITAL RETINAL CAMERA CX-1 (K092565)Canon Components, Inc.2010-03-18
SOFTVIEW, MODEL 2.01 (K092363)Riverain Medical Group2010-03-18
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION (K092944)Dana Products, Inc.2010-03-18
LED LIGHT SOURCE (K093792)Sunoptic Technologies, LLC2010-03-18
BIO-OSS COLLAGEN (K092428)Ed. Geistlich Soehne AG Fuer Chemische Industrie2010-03-18
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 (K100532)Depuy Mitek, A Johnson & Johnson Company2010-03-17
VERSACLOSE, MODEL VC-200-01 (K100572)Anulex Technologies, Inc.2010-03-17
HARMONY VLED SURGICAL LIGHTNING SYSTEM (K100395)STERIS Corporation2010-03-17
MODEL VISULAS 532S LASER WITH THE VITE OPTION (K100035)Carl Zeiss Meditec, AG2010-03-17
WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES (K092558)Harvard Medical Devices , Ltd.2010-03-17
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS (K093965)C.R. Bard, Inc.2010-03-17
OMNITECH LARGE, TRIMED COMPRESSION SCREW (K093676)TriMed, Inc.2010-03-17
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER (K100520)Nipro Medical Corporation2010-03-17
GORE HYBRID VASCULAR GRAFT (K093934)W.L. Gore & Associates2010-03-17
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W (K100474)Quicklase Limited2010-03-16
SCUBA BILIARY STENT SYSTEM (K092352)Invatec S.P.A.2010-03-16
LITEPAC, MODEL 682 (K100490)ClearStream Technologies , Ltd.2010-03-16
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) (K092427)Albert Davydov Dds PC Professional2010-03-16
IMPIX MANTA CERVICAL INTERBODY DEVICE (K100484)Medicrea2010-03-16
POLESTAR, MODEL N-30 (K092308)Medtronic Navigation Israel, Ltd.2010-03-16
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 (K093066)Infimed, Inc.2010-03-16
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER (K092825)Spinecraft, Inc.2010-03-16
NEUROSCOUT STEERABLE GUIDEWIRE (K100351)Codman & Shurtleff, Inc.2010-03-16
GYNECARE TVT EXACT CONTINENCE SYSTEM (K100485)ETHICON, Inc.2010-03-16
COOPDECH ENDOBRONCHIAL BLOCKER TUBE (K093888)Daiken Medical Co, Ltd.2010-03-16
OASIS MRI SYSTEM (K093044)Hitachi Medical Systems America, Inc.2010-03-16
VESISCAN (K093485)Life-Tech, Inc.2010-03-16
MBCP+ (K093122)Biomatlante2010-03-15
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER (K093232)Great Batch Medical2010-03-15
MESH GPS - LARGE, SMALL, SM, SM SMALL (K092726)Surgical Structures , Ltd.2010-03-15
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K091555)Taidoc Technology Corporation2010-03-15
COAXIAL APPLICATOR SYSTEM (K091722)Biomet, Inc.2010-03-12
ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 (K093795)Actherm, Inc.2010-03-12
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR (K093881)GE Healthcare Finland Oy2010-03-12
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER (K092922)Sonoscape Company Limited2010-03-12
EZLASE 3 LASER SYSTEM (K093852)Biolase Technology, Inc.2010-03-12
LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 (K093815)Millipore Corporation2010-03-12
ELECSYS RUBELLA IGM IMMUNOASSAY (K092322)Roche Diagnostics2010-03-12
C. ALBICANS/C. GLABRATA PNA FISH (K092784)Advandx, Inc.2010-03-12
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS (K092265)Medacta International S.A.2010-03-12
SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES (K092950)Solaris Medical Technology, Inc.2010-03-12
DIDGET WORLD REPORTS (K093930)Bayer Healthcare, LLC2010-03-12
VCARE DX (K093556)Conmed Corporation2010-03-12
ZR DENTAL BLOCK (K093571)Ams Co., Ltd.2010-03-12
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