Atlas FDA

2009

3,008 FDA 510(k) clearances · Clearance year

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RecordFirmDate
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK (K092034)Pt. Smartglove Indonesia2009-10-19
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 (K090487)Coeur, Inc.2009-10-19
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K092895)Sorin Group Italia S.R.L.2009-10-19
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 (K091846)Beckman Coulter, Inc.2009-10-16
CYPHER DICOM PRINT SOLUTION (K092280)Virtual Imaging, Inc.2009-10-16
ABX PENTRA TPU CAL, MODEL A11A01898 (K092570)HORIBA ABX SAS2009-10-16
GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. (K091833)Gemore Technology Co, Ltd.2009-10-16
GUIDED MEASUREMENT CATHETER (GMC) (K091780)Mediguide, Ltd.2009-10-16
THAI NIPPON MALE LATEX CONDOM (K081265)Thai Nippon Rubber Industry Co., Ltd.2009-10-16
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR (K091516)Well Lead Medical Co., Ltd.2009-10-16
NOBEL/PROCERA IMPLANT BRIDGE (K091848)Nobel Biocare AB2009-10-16
SJM ATTUNE ANNULOPLASTY RING (K092876)St Jude Medical2009-10-16
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER (K092879)Valleylab2009-10-16
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (K092913)Ep Medsystems2009-10-16
GUIDED MEDICAL POSITIONING SYSTEM (GMPS) (K091781)Mediguide, Ltd.2009-10-16
IDENTEVENT, VERSION 1.0G (K092039)Optima Neuroscience, Inc.2009-10-16
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260)Roche Diagnostics2009-10-16
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (K092337)Baylis Medical Co., Inc.2009-10-16
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 (K091065)J. Morita USA, Inc.2009-10-16
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 (K091458)Ev3 Neurovascular2009-10-15
MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 (K092177)Invatec S.P.A.2009-10-15
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 (K092838)Masimo Corporation2009-10-15
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL (K091471)Cartagloves S.A.2009-10-15
BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION (K092035)Bicon, LLC2009-10-15
LIFEBRIDGE B2T, MODEL 7001 (K090006)Lifebridge Medizintechnik AG2009-10-15
C-THRU SPINAL SYSTEM (K092336)Ebi, L.P.2009-10-15
STENT GRAFT BALLOON CATHETER (K091624)Via Biomedical, Inc.2009-10-15
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K092691)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009-10-15
TANDA RESTORE, MODEL PTSCS (K090008)Pharos Life Corporation2009-10-15
RHYTHM OF LIFE, MODEL R0901-05 (K092408)Rapid Response Solutions, LLC2009-10-14
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 (K091420)Solta Medical, Inc.2009-10-14
GRIND GUARD (K090472)Archtek, Inc.2009-10-14
SONICFILL 2010 (K091091)Sybron Dental Specialties, Inc.2009-10-14
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 (K091703)Concentric Medical, Inc.2009-10-14
CAD 12, COLONOSCOPY ASSIST DEVICE (K092156)Softscope Medical Technologies, Inc.2009-10-14
ELECTROFLUIDGRAPH (K091369)Akern USA, LLC2009-10-14
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO (K091140)Vidacare Corporation2009-10-14
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC (K091709)Edwards Lifesciences, LLC2009-10-13
DISPOSAL ECG ELECTRODES, MODEL EASYRODE (K092389)Suzuken Co., Ltd.2009-10-13
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES (K090017)Biosense Webster, Inc.2009-10-13
DISPOSABLE TPE INFUSION SET (K090459)Shan Dong Wei Gao Group Medical Polymer Products2009-10-13
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM (K090190)Nuclemed S.A.2009-10-09
PATLOG 2.0 (K092939)Oncolog Medical QA AB2009-10-09
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) (K092103)VATECH Co., Ltd.2009-10-09
RAINBOW BLOCK (K092513)Genoss Co., Ltd.2009-10-09
HEARTWAY POWER MOBILITY SCOOTER, S12 (K092650)Heartway Medical Products Co., Ltd.2009-10-09
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (K092757)Thera-Test Laboratories, Inc.2009-10-09
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL (K092747)Philips Medical Systems (Cleveland), Inc.2009-10-09
RADIANALYZER XPRESS (K092105)Radi Medical Systems AB2009-10-09
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM (K090653)Arkray Factory USA, Inc.2009-10-09
SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES (K091574)Supplidores Unidos Internacionales, S.A.2009-10-09
CAROTID COIL 5000004901 (K092962)Shanghai Chenguang Medical Technologies Co, Ltd.2009-10-09
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092109)Zhangjiangang All Fine Rubber-Plastic Products Co.2009-10-09
SIMPLYGO HANDS FREE BREAST PUMP (K092770)Evenflo Company, Inc.2009-10-09
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) (K090563)Instrumentation Laboratory CO2009-10-09
AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) (K092432)Jawon Medical Co., Ltd.2009-10-09
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (K091787)Ivy Biomedical Systems, Inc.2009-10-09
MAXMORESPINE TOM STICK (K083552)Hoogland Spine Products, GmbH2009-10-09
VOYAGER COMPACT IMAGING SYSTEM (K092182)Ardent Sound, Inc.2009-10-09
EP-WORKMATE SYSTEM, VERSION 4.2 (K092810)St Jude Medical2009-10-09
3 WAY SILICONE FOLEY BALLOON CATHETER (K091767)Cook Urological, Inc.2009-10-09
ELETONE CREAM (K092297)Ferndale Pharma Group, Inc.2009-10-09
APLIO MX SSA-780A, VERSION 1.0 (K092948)Toshiba America Medical Systems, In.C2009-10-09
LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L (K091440)Bovie Medical2009-10-09
BD SPINAL NEEDLE 27G (K091758)Becton Dickson & Co.2009-10-09
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT (K090705)Ortho Development Corp.2009-10-09
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO (K090991)E-Woo Technology2009-10-09
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT (K092049)Sainath Intellectual Properties, LLC2009-10-09
AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 (K092806)K-Jump Health Co., Ltd.2009-10-09
AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR (K092225)Amylior, Inc.2009-10-09
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS (K090650)Spsmedical Supply Corp.2009-10-09
LAMINOPLASTY FIXATION SYSTEM (K091623)Nuvasive, Inc.2009-10-09
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE (K091584)Merit Medical Systems, Inc.2009-10-09
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 (K091216)Siemens Healthcare Diagnostics2009-10-09
BUSSE SURGICAL DRAPES III (K092212)Busse Hospital Disposables, Inc.2009-10-09
SMARTTRACK SYSTEM (K091803)Nexus6, Ltd.2009-10-09
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) (K092566)Nanosphere, Inc.2009-10-09
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 (K090051)Levitronix, LLC2009-10-08
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D (K092763)Well-Life Healthcare Limited2009-10-08
ENGAGE/ENGAGE TR (K092575)St Jude Medical2009-10-08
REMOTE INFRARED THERMOMETER, MODEL RC002 (K090361)Rycom Electron Technology Limited2009-10-08
MICROSELECTRON HDR V2, MODEL 105.999 (K092804)Nucletron Corp.2009-10-08
MAXIFLO, TAPERFLO (K092863)Vascutek, Ltd.2009-10-08
MODIFICATION TO FMRI HARDWARE SYSTEM (K092253)Nordicneurolab2009-10-08
PMD VIEWER (K092204)Spencer Technologies2009-10-08
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (K092014)Onset Medical Corporation2009-10-08
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE (K092509)Edwards Lifesciences, LLC2009-10-08
MTD 4000 (K091540)Mettler Electronics Corp.2009-10-08
HOFFMAN XPRESS LINE EXTENSION (K092834)Howmedica Osteonics Corp.2009-10-08
BODY COMPOSITION ANALYZER, MODEL: IOI 353 (K092431)Jawon Medical Co., Ltd.2009-10-08
IMAGEGRID RADIOLOGY VIEWER SYSTEM (K092949)Candelis, Inc.2009-10-08
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092516)Zi BO Yuxiang Gloves Co., Ltd.2009-10-07
G-PROX ENDOSCOPIC GRASPER, MODEL 205333 (K093018)Usgi Medical2009-10-07
TAKE 1 (K091613)Kerr Corp.2009-10-07
ISPIRA RESUSCITATION UNIT (K092085)Neoforce Group, Inc.2009-10-07
OR-LIGHT (K090724)Yperion Technology2009-10-07
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO (K091918)Genoray Co., Ltd.2009-10-07
NOBELPROCERA IMPLANT BRIDGE ZIRCONIA (K091907)Nobel Biocare AB2009-10-06
PHOTEX30 DIODE LASER SERIES: 980, 810, 940 (K092197)Biotex, Inc.2009-10-06
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM (K092287)Nuvasive, Inc.2009-10-06
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