Atlas FDA

Cardiovascular

19,134 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
GORE PRECLUDE VESSEL GUARD (K061727)W. L. Gore & Associates, Inc.2006-08-07
NAUTIFLUX (K060010)Sedat2006-08-04
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS (K061450)Hospira, Inc.2006-08-04
12 RL ALGORITHM (K060307)Ge Medical Systems Information Technologies2006-08-04
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 (K061963)Micrus Endovascular Corporation2006-08-04
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER (K061015)St Jude Medical2006-08-03
VISION VXC CENTRAL STATION, MODEL 4300 (K061675)Invivo Corporation2006-08-02
PEPER (K060297)Medical Monitors, Ltd.2006-08-02
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 (K061822)Omron Healthcare, Inc.2006-08-02
LANGSTON DUAL LUMEN CATHETER (K061565)Vascular Solutions, Inc.2006-08-02
MEDCOMP VASCU-SHEATH II (K053092)Medcomp2006-08-01
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR (K061857)Bio Compression Systems, Inc.2006-08-01
VENTURE WIRE CONTROL CATHETER, MODEL WCC (K061843)St Jude Medical2006-08-01
12SL ECG ANALYSIS PROGRAM (K060833)Ge Medical Systems Information Technologies2006-08-01
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET (K061513)Smiths Medical Asd, Inc.2006-08-01
MASIMO SET RADICAL 7 PULSE CO-OXIMETER (K061204)Masimo Corporation2006-07-27
PULSION PICCO PLUS, MODEL 8100 (K060898)Pulsion Medical Systems AG2006-07-25
SURGI-CUF REUSABLE, RS SERIES (K061962)Ethox International2006-07-25
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 (K061743)Maquet Cardiopulmonary, AG2006-07-21
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES (K061977)Pinmed, Inc.2006-07-21
ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS (K060675)Envitec-Wismar GmbH2006-07-17
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS (K061710)St Jude Medical2006-07-14
TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM (K061452)Tung FU Electric Co., Ltd.2006-07-12
INSPECTRA STO2 TISSUE OXYGENATION MONITOR (K061619)Hutchinson Technology, Inc.2006-07-12
QL LOCKING SYRINGE (K060643)Atrion Medical Products, Inc.2006-07-12
AGILIS NXT STEERABLE INTRODUCER (K061363)St Jude Medical2006-07-12
GALAXY (K061816)Larsen & Toubro Limited2006-07-12
TRIACTIV FX EMBOLIC PROTECTION SYSTEM (K061772)Kensey Nash Corp.2006-07-11
BIOTRONIK ENDOCARDIAL PACING LEADS (K061212)Biotronik, Inc.2006-07-10
STARCLOSE INTRODUCER SET MODEL- 1002 (K060902)Abbott Vascular, Inc.2006-07-07
INFINITY MASIMO SET SP02 POD (K061329)Draeger Medical Systems, Inc.2006-07-07
LBI CATHETER SYSTEM (K053372)Lumen Biomedical, Inc.2006-06-30
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U (K061558)Microlife Intellectual Property GmbH2006-06-29
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) (K051278)Rg Ent., Inc.2006-06-29
CAROTID ACCESS KIT (K060666)Terumo Medical Corp.2006-06-29
Y-CLICK CONNECTOR (K060759)Elcam Medical Acal2006-06-29
GERATHERM SOS-RESCUE BAG (K051336)R.G. Enterprises, Inc.2006-06-29
NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 (K060616)PHD Medical2006-06-29
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING (K061527)Sorin Group Italia S.R.L.2006-06-27
BOD POD (K060848)Life Measurement, Inc.2006-06-27
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (K061159)Hospira, Inc.2006-06-26
BLOOD PRESSURE METER, MODEL CH-311B (K061161)Citizen Watch Co., Ltd.2006-06-26
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 (K052908)Infraredx, Inc.2006-06-23
AFIBALERT ATRIAL FIBRILLATION DETECTOR (K052767)Lechnologies Research, Inc.2006-06-23
SPIDERX EMBOLIC PROTECTION DEVICE (K053195)Ev3, Inc.2006-06-23
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 (K061254)Medtronic Perfusion Systems2006-06-23
VS-800 VITAL SIGNS MONITOR (K060281)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-06-23
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY (K060745)Asahi Intecc Co., Ltd.2006-06-23
HI-TORQUE WHISPER VIEW GUIDE WIRE (K061453)Guidant Corp.2006-06-22
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR (K061456)A&D Engineering, Inc.2006-06-21
DEFIBRILLATOR CABLE TESTER, MODEL DT2200 (K061606)Medical Devices/Padpro, Inc.2006-06-21
SMDIE DEVICE INTERFACING SYSTEM (K061590)Siemens Medical Solutions Health Services Corporat2006-06-21
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 (K061546)Maquet Cardiopulmonary, AG2006-06-20
ACUMEN SINGLE-LUMEN DELIVERY SHEATH (K053400)Acumen Medical, Inc.2006-06-19
CARTO RMT EP NAVIGATION SYSTEM V8 (K060047)Biosense Webster, Inc.2006-06-19
LNCS AND SPO2.COM SENSORS (K060143)Masimo Corporation2006-06-16
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE (K053381)Welch Allyn, Inc.2006-06-15
DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES (K060524)Dolphin Medical, Inc.2006-06-15
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U (K061403)Microlife Intellectual Property GmbH2006-06-14
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 (K060766)Omron Healthcare, Inc.2006-06-09
SENTRY OTC MONITOR (K061088)Honeywell Hommed, LLC2006-06-09
GENESIS OTC MONITOR (K061087)Honeywell Hommed, LLC2006-06-09
AS101, BLOOD PRESSURE CUFF (K060871)Wenzhou Longwan Medical Instrument Company2006-06-09
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC (K060686)Microlife Intellectual Property GmbH2006-06-09
CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 (K060820)Suntech Medical, Inc.2006-06-07
BRIVANT GUIDEWIRE (K060551)Brivant Limited2006-06-07
DUTECK BODY COMPOSITION ANALYZER (K060642)Duteck Industrial Co., Ltd.2006-06-07
STOCKERT HEATER-COOLER SYSTEM 3T (K052601)Sorin Group Deutschland GmbH2006-06-06
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250 (K061073)Taidoc Technology Corporation2006-06-02
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX (K061171)Biosphere Medical, Inc.2006-06-02
STOCKERT S5 SYSTEM (K060053)Sorin Group Deutschland GmbH2006-06-02
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W (K061031)Sorin Group Italia S.R.L.2006-06-02
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE (K060449)Guidant Corporation2006-05-30
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (K061052)Philips Medical Systems North America, Inc.2006-05-26
MODIFIED MERCI RETRIEVER, MODEL 90092 (K061059)Concentric Medical, Inc.2006-05-25
BC100 BODY COMPOSITION ANALYSIS SYSTEM (K060552)Athletic Iq, Inc.2006-05-24
CARDIOFAX CE, MODEL ECG-1500 A (K052511)Nihon Kohden America, Inc.2006-05-24
DVTCARE CA5 (K061125)Doctors Orders2006-05-23
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 (K061072)Maquet Cardiopulmonary, AG2006-05-23
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R (K061127)Medtronic Vascular2006-05-23
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M (K061112)Conmed Corporation2006-05-22
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 (K061191)Measurement Specialties, Inc.2006-05-22
ARGUS, MODEL LCM (K053207)Schiller AG2006-05-19
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 (K061063)Foxhollow Technologies, Inc.2006-05-18
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS (K053193)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-05-18
ENPATH MEDICAL STEERABLE SHEATH (K061119)Enpath Medical, Inc.2006-05-18
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES (K052691)Suretek Medical2006-05-17
MODIFICATION TO POWERHEART ECD (K060934)Cardiac Science Corporation2006-05-15
MORTARA SURVEYOR TELEMETRY CENTRAL STATION (K060135)Mortara Instrument, Inc.2006-05-15
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (K060321)American Diagnostic Corp.2006-05-15
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE (K061185)GE Healthcare2006-05-15
IVENA VASCULAR PATCH (K060396)Atrium Medical Corp.2006-05-12
MICRUS COURIER MICROCATHETERS (K060116)Micrus Endovascular Corporation2006-05-12
KONICA MINOLTA PULSOX-300, 300I (K053419)Konica Minolta Sensing, Inc.2006-05-11
ESTECH AORTIC EASY FLOW CANNULA (K060101)Endoscopic Technologies, Inc.2006-05-10
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 (K061000)Cook Vascular, Inc.2006-05-10
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 (K060925)ACON Laboratories, Inc.2006-05-09
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 (K051760)Stereotaxis, Inc.2006-05-05
HOMMED CENTRAL STATION, VERSION 3.5 (K053453)Honeywell Hommed, LLC2006-05-05
INTRODUCER ASSEMBLY WITH ROTATOR LOCK (K060519)Teleflex Medical2006-05-05
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