Atlas FDA

Cardiovascular

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

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RecordFirmDate
HOT DOG PATIENT WARMING SYSTEM (K052392)Augustine Biomedical & Design, LLC2006-05-04
CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR (K060065)Oridion Capnography, Inc.2006-05-04
PM-9000 EXPRESS PATIENT MONITOR (K053234)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-05-04
REPROCESSED BALOON INFLATION DEVICE (K053188)Sterilmed, Inc.2006-05-04
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K060904)Rex Medical, L.P.2006-04-28
PRESEP OLIGON OXIMETRY CATHETERS (K060093)Edwards Lifesciences, LLC2006-04-28
MICRUS GUIDE WIRE, WATUSI 0.014 (K053265)Micrus Endovascular Corporation2006-04-28
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 (K051419)Inditherm Medical2006-04-27
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F (K053491)Penumbra, Inc.2006-04-27
AMPLATZER NOODLEWIRE GUIDEWIRE (K053187)Aga Medical Corp.2006-04-27
COOLGARD 3000 (K060308)Alsius Corp.2006-04-26
ECP HEALTH SYSTEM, MODEL 2005 (K052611)Ecp Health, Inc.2006-04-26
PHYSIOGLOVE ES (K050674)Commwell , Ltd.2006-04-25
THROMCAT THROMBECTOMY CATHETER SYSTEM (K060016)Kensey Nash Corp.2006-04-25
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER (K060660)Edwards Lifesciences, LLC2006-04-25
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 (K053263)Cardionet, Inc.2006-04-25
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM (K060807)Biotronik, Inc.2006-04-24
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 (K060865)Arizant Healthcare, Inc.2006-04-24
HL888SF (K060835)Health & Life Co., Ltd.2006-04-21
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 (K060954)St. Jude Medical, Inc.-Endocardial Solutions2006-04-21
MODIFICATION TO HEALTH BUDDY APPLIANCE (K060843)Health Hero Network, Inc.2006-04-20
VITELCARE C-TURTLE PATIENT MONITORING SYSTEM (K060712)Visual Telecommunications Network, Inc.2006-04-19
ATRIA 3100, ATRIA 6100 (K060167)Cardiac Science Corporation2006-04-19
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER (K060757)Irvine Biomedical, Inc.2006-04-19
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K053356)Ge Medical Systems Information Technologies2006-04-19
PROACT WITH GEL OR PROACT 1 (K052243)Proact, Inc.2006-04-12
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM (K060223)Draeger Medical Systems, Inc.2006-04-12
SYMMETRY BALLOON DILATATION CATHETER (K060959)Boston Scientific Corporation2006-04-12
INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS (K060039)Draeger Medical Systems, Inc.2006-04-12
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER (K060327)Vascular Solutions, Inc.2006-04-12
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER (K060960)Boston Scientific Corporation2006-04-12
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV (K060729)Health & Life Co., Ltd.2006-04-12
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 (K051984)Boston Scientific Corp2006-04-10
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (K060315)Healthstats International Pte. , Ltd.2006-04-07
MACTRODE 3 (K060661)Ge Medical Systems Information Technologies2006-04-07
RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 (K051227)Renu Medical, Inc.2006-04-07
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES (K060309)Arrow Intl., Inc.2006-04-06
TRAM MODULE (K053121)GE Healthcare2006-04-05
SWIRLGRAFT VASCULAR ACCESS GRAFT (K060741)Veryan Medical Limited2006-04-05
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) (K051438)Alliance Medical, Inc.2006-04-04
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 (K052319)Impedimed Pty , Ltd.2006-04-04
MODIFICATION TO INFINITY EXPLORER (K060254)Draeger Medical Systems, Inc.2006-04-04
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K (K060342)Rossmax International , Ltd.2006-04-04
SUPER SHEATH XL INTRODUCER SHEATH (K060190)Togo Medikit Co., Ltd.2006-04-04
SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H (K060655)Biotronik, Inc.2006-04-04
PMP4 BP PRO BLOOD PRESSURE MONITOR (K060703)Card Guard Scientific Survival , Ltd.2006-04-04
ATRIUM FLIXENE GRAFT (K060124)Atrium Medical Corp.2006-03-30
RF TUNNELER WIRE (K051670)Baylis Medical Co., Inc.2006-03-30
PM-50 PULSE OXIMETER (K052693)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-03-30
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 (K060197)Zargis Medical Corp.2006-03-29
SYVEKEXCEL (K053300)Marine Polymer Technologies, Inc.2006-03-28
IQMARK EZ STRESS (K052898)Brentwood Medical Technology Corp.2006-03-28
TITAN GUIDEWIRE (K060454)Lake Region Mfg., Inc.2006-03-24
THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS (K060541)Philips Medizin Systeme Boblingen GmbH2006-03-24
ISIGHT IMAGING CATHETER, MODEL 38986 (K060175)Boston Scientific Corp2006-03-24
INQUIRY AFOCUS II DIAGNOSTIC CATHETER (K053582)Irvine Biomedical, Inc.2006-03-21
KAVS - CATHETER, MODELS 1107100 & 1107060 (K052844)Richter & Rothe AG2006-03-20
MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS (K053477)Masimo Corporation2006-03-16
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (K053431)Medtronic, Ireland2006-03-16
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER (K051675)Biodynamics Corp.2006-03-16
8F SHERPA NX GUIDE CATHETER (K060418)Medtronic Vascular2006-03-15
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB (K052555)Rand S.R.L.2006-03-15
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K060572)Boston Scientific Corporation2006-03-15
IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001 (K060504)Ideal Life, Inc.2006-03-14
PVS 2000 SYNCHRO2 GUIDEWIRE (K053268)Boston Scientific - Precision Vascular2006-03-13
COMPASS COMPRESSION ASSIST HANDLE (K053398)Semler Technologies, Inc. Dba2006-03-10
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE (K053194)Biosense Webster, Inc.2006-03-09
QUICKCAT EXTRACTION CATHETER (K060092)Kensey Nash Corp.2006-03-09
LYSUS INFUSION SYSTEM (K060422)Ekos Corp.2006-03-09
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS (K053645)Arizant Healthcare, Inc.2006-03-09
DP240 240 HOUR DOPPLER PROBE (K052989)Deltex Medical2006-03-08
ACTIVECARE ++ SYSTEM (K060146)Medical Compression Systems (Dbn) , Ltd.2006-03-08
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 (K053217)St Jude Medical2006-03-08
RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A (K060077)Real Tone Technology Corp.2006-03-08
THEROX INFUSION CATHETER, MODEL INCA-1 (K052637)Therox, Inc.2006-03-08
TECHDEVICE GUIDEWIRE (K053251)Techdevice Corporation2006-03-08
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER (K060224)Cook Incorporated2006-03-06
ACUITY STEERABLE STYLET ACCESSORY (K053019)Guidant Corporation2006-03-03
INNOCOR (K051907)Innovision A/S2006-03-02
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR (K052450)Kodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-02-28
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K053609)Edwards Lifesciences, LLC2006-02-28
TECHDEVICE OCCLUSION BALLOON CATHETER (K051137)Techdevice Corporation2006-02-24
CPS DIRECT SL OUTER CATHETER (K053277)St Jude Medical2006-02-24
GERATHERM SOS-RESCUE BLANKET (K051097)Rg Ent., Inc.2006-02-24
REPROCESSED COMPRESSION SLEEVES (K060049)Alliance Medical Corp.2006-02-24
LOOP RECORDER VITAPHONE, 3100 SERIES (K053378)Tms Telemedizinische Systeme GmbH2006-02-23
INFINITY GAMMA / GAMMAXL, INFINITY VISTA (K053484)Draeger Medical Systems, Inc.2006-02-22
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) (K052828)Hospira, Inc.2006-02-17
SPIDERX EMBOLIC PROTECTION DEVICE (K052659)Ev3, Inc.2006-02-17
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K052057)Medtronic Emergency Response Systems, Inc.2006-02-17
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K052676)Kodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-02-17
TITAN STEERABLE (PTCA) GUIDEWIRE (K052347)Lake Region Mfg., Inc.2006-02-17
THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS (K060221)Philips Medizin Systeme Boeblingen GmbH2006-02-17
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES (K060091)Alliance Medical Corp.2006-02-17
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS (K053575)Hygia Health Services, Inc.2006-02-15
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (K052965)Guidant Corporation2006-02-13
REPROCESSED COMPRESSION SLEEVES (K053316)Alliance Medical Corp.2006-02-13
MARCH HEALTHCARE HEALTH MONITORING KIT (K060194)March Healthcare Corporation2006-02-13
PBS MODEL 701A COMPRESSION THERAPY DEVICE (K060220)Mego Afek2006-02-09
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 (K053618)Hutchinson Technology, Inc.2006-02-08
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