Atlas FDA

Cardiovascular

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

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RecordFirmDate
Passeo-35 PTA Catheter (K142379)Biotronik, Inc.2014-12-05
CARDIOSPY ECG HOLTER SYSTEMS (K140847)Labtech Kft.2014-12-05
RADAR VASCULAR COMPRESSION DEVICE (K142122)Advanced Vascular Dynamics2014-12-04
PULSE OXIMETER (K141105)Hunan Accurate Bio-Medical Technology Co., Ltd.2014-12-04
VESOFLOW PLUS DVT COMPRESSION DEVICE (K141064)Caremed Supply, Inc.2014-12-04
ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) (K142728)Medical Compressions System (Dbn) , Ltd.2014-12-04
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER (K141529)Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S2014-12-03
SURVEYOR S4 MOBILE MONITOR (K141020)Mortara Instrument, Inc.2014-12-03
AliveCor Heart Monitor (K142672)AliveCor, Inc.2014-12-03
ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
ENDOLUMINAL OCCLUSION SYSTEM (EOS) (K133924)Artventive Medical Group, Inc.2014-12-03
M3290B Philips IntelliVue Information Center iX (K143057)Philips Medical Systems2014-12-03
MAC 800 Resting ECG Analysis System (K142288)Ge Medical Systems China Co., Ltd.2014-12-03
MEDUSA VASCULAR PLUG, (K140796)Endoshape, Inc.2014-12-02
Skintact, various other tradenames (K142803)Leonhard Lang GmbH2014-12-02
CLEARLUMEN THROMBECTOMY SYSTEM (K140296)Walk Vascular, LLC2014-12-02
SIVR56-T KIT (K133994)Barco N.V.2014-12-01
BP652N (HEM-6300-Z) (K142917)Omron Healthcare, Inc.2014-12-01
HEARTFLOW FFRCT (DEN130045)Heartflow2014-11-26
GENESIS TOUCH SYSTEM (K141792)Honeywell Hommed2014-11-25
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231)Zeller Power Products (Battery Beast, LLC)2014-11-25
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (K133989)Mortara Instrument, Inc.2014-11-25
DR300 HOLTER MONITOR (K142424)North East Monitoring, Inc.2014-11-25
Masimo Root Monitoring System and Accesories (K142394)Masimo Corporation2014-11-25
PREDICATE III GUIDEWIRE (K142393)Lake Region Medical2014-11-25
TURNPIKE CATHETER (K142065)Vascular Solutions, Inc.2014-11-25
TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT (K140768)Lepu Medical Technology (Bejing) Co., Ltd.2014-11-25
VASCU-GUARD Peripheral Vascular Patch (K142461)Synovis Life Technologies, Inc.2014-11-25
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K141682)Infraredx, Inc.2014-11-24
LG SMARTHEALTH (K133997)Lg Electronics2014-11-21
GLIDESHEATH SLENDER (K142183)Terumo Medical Corporation2014-11-21
ZEUS (ZIO ECG Utilization Service) System (K142681)iRhythm Technologies, Inc.2014-11-21
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT (K142062)Vascular Flow Technologies, Ltd.2014-11-20
Gel-Block 10X embolization pledgets (K143038)Vascular Solutions, Inc.2014-11-20
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) (K140569)Maquet Cardiopulmonary, AG2014-11-19
MORTARA MONITORING WAVEFORM VIEWER (K141811)Mortara Instrument, Inc.2014-11-19
CENTERCROSS CATHETER (K140910)Roxwood Medical, Inc.2014-11-19
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K141755)Sejoy Electronics & Instruments Co., Ltd.2014-11-19
ECVUE MAPPING SYSTEM (K140497)Cardioinsight Technologies, Inc.2014-11-19
ZOLL X SERIES (K141774)ZOLL Medical Corporation2014-11-19
Bio-Medicus Adult Cannulae and Introducer (K142673)Medtronic, Inc.2014-11-18
INTERMITTENT PNEUMATIC COMPRESSION DEVICE (K141390)Wuhan Landing Medical Hi-Tech, Ltd.2014-11-18
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K141617)Rex Medical, L.P.2014-11-14
Panorama Patient Monitoring Network (K142601)Shenzhen Mindray Bio-Medical Electronics Co.2014-11-14
TECOTHERM NEO (T NEO) (K140078)Inspiration Healthcare, Ltd.2014-11-14
MICRO GUIDE CATHETER ELITE (K140438)Cordis Corp., A Johnson & Johnson Co.2014-11-14
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter (K142565)Stryker Neurovascular2014-11-14
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 (K140466)St. Jude Medical Systems AB2014-11-13
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector (K142254)St Jude Medical2014-11-13
ONE Snare Endovascular Microsnare System (K142265)Merit Medical Systems, Inc.2014-11-13
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath (K142301)Cook Vascular, Inc.2014-11-12
AngioVac Cannula (K142593)AngioDynamics, Inc.2014-11-12
ZOLL E SERIES ALS (K140502)ZOLL Medical Corporation2014-11-06
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator (K142640)Bio Compression Systems, Inc.2014-11-06
FlexCath Select Steerable Sheath (10 French) (K142684)Medtronic Cryocath, LP2014-11-06
SPEX SUPPORT CATHETER (K141649)Reflow Medical2014-11-05
Unimed Disposable ECG lead wires (K142489)Unimed Medical Supplies, Inc.2014-11-04
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES (K142088)Grandway Technology (Shenzhen) Limited2014-10-31
VC150 VITAL SIGNS MONITOR (K133810)Innokas Yhtyma2014-10-30
Ascendra Balloon Aortic Valvaloplasty Catheter (K142199)Edwards Lifesciences2014-10-29
EpiAccess System (K142245)Epiep, Inc.2014-10-29
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY (K141686)Smith Medical Asd, Inc.2014-10-28
HYPERQ ACS-100 SYSTEM (K140020)Bsp-Biiological Signal Processing, Ltd.2014-10-28
Fortrex 0.035 OTW PTA Balloon Catheter (K142654)Covidien, LLC2014-10-28
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (K141809)Defibtech, LLC2014-10-27
RENOVOCATH RC120 (K141175)Renovorx, Inc.2014-10-24
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface (K142784)Medtronic, Inc.2014-10-24
Vasc Band hemostat (K142359)Lepu Medical Technology (Beijing) Co., Ltd.2014-10-23
TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 (K133157)Medtronic, Inc.2014-10-23
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE (K141339)Asahi Intecc Co., Ltd.2014-10-23
SOLITAIRE 2 REVASCULARIZATION DEVICE (K141491)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-10-22
Antegrade LeMills Valvulotome (K142660)LeMaitre Vascular, Inc.2014-10-17
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM (K141801)Covidien, LLC2014-10-16
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER (K140543)Merit Medical Systems, Inc.2014-10-16
ONESTEP CPR II MULTI-FUNCTION ELECTRODE (K133441)Bio-Detek, Inc.2014-10-10
SOFIA DISTAL ACCESS CATHETER (K142014)MicroVention, Inc.2014-10-10
ITCLAMP 50 (K140805)Innovative Trauma Care, Inc.2014-10-09
BLOOD PRESSURE MONITOR (K141416)Shenzhen Pump Medical System Co., Ltd.2014-10-09
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (K132592)Cook, Inc.2014-10-09
IDC INTERLOCKING DETACHABLE COIL (K141378)Boston Scientific Corporation2014-10-08
A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR (K141201)A & D Co., Ltd.2014-10-08
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR (K141160)A & D Co., Ltd.2014-10-07
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER (K141139)Zoll Circulation2014-10-03
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) (K141542)Covidien, LLC2014-10-02
WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K141547)Reflow Medical2014-09-30
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE (K141113)Spacelabs Healthcare, Ltd.2014-09-26
PTA BALLOON DILATATION CATHETER (K141150)Boston Scientific Corp2014-09-25
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath (K142546)Spectranetics, Inc.2014-09-25
Ultraverse 035 PTA Balloon Dilatation Catheter (K142261)Bard Peripheral Vascular, Inc.2014-09-24
BIOSPACE BODY COMPOSITION ANALYZER (K141483)Biospace Corporation Limited2014-09-23
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER (K141453)Lightlab Imaging, Inc.2014-09-19
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS (K141998)Pinghu Sama Medical Packing Co., Ltd.2014-09-19
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR (K133753)Infobionic, Inc.2014-09-19
APOLLO BALLOON DILATATION CATHETER (K133852)Brosmed Medical2014-09-19
EDWARDS ESHEATH INTRODUCER SET (K141696)Edwards Lifesciences2014-09-18
TRUE BA V BALLOON VALVULOPLASTY CATHETER (K141985)C.R. Bard, Inc.2014-09-18
MIVI 6F GUIDE CATHETER (K140557)Mivi, LLC2014-09-18
TRANSONIC HCM 103 SYSTEM (K134035)Transonic Systems, Inc.2014-09-17
Arrow GPSCath Balloon Dialation Catheter (150 cm) (K142300)Hotspur Technologies, Inc.,2014-09-17
TRANSONIC HCM 102 SYSTEM (K140017)Transonic Systems, Inc.2014-09-16
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