Atlas FDA

Cardiovascular

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

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RecordFirmDate
Spacelabs Lifescreen PRO Analyzer (K201921)Spacelabs Healthcare, Ltd.2021-03-26
Aneroid Sphygmomanometer (K203620)Wuxi Exanovo Medical Instrument Co., Ltd.2021-03-23
MyHomeDoc (K202483)Myhomedoc , Ltd.2021-03-23
Tigertriever and Tigertriever 17 Revascularization Devce (K203592)Rapid Medical Ltd.2021-03-23
Movement and Compressions System (the MAC System) (K203052)Recovery Force, LLC2021-03-21
WorkMate Claris System (K210392)Abbott2021-03-11
FloPump 57mL Centrifugal Pump (K193663)International Biophysics Corporation2021-03-10
Blood Pressure Monitor (K202891)Guangdong Transtek Medical Electronics Co., Ltd.2021-03-09
ZOLL Propaq M (K202375)ZOLL Medical Corporation2021-03-09
Century Perfusion System (K202125)Century Hlm, LLC2021-03-07
CPR BAND (K201581)Credo2021-03-06
SafeSept Blunt Needle (K210328)Pressure Products Medical Device Manufacturing, LLC2021-03-05
Reprocessed Inquiry Steerable Diagnostic EP Catheter (K203261)Innovative Health, LLC2021-03-05
NuVision ICE Catheter (K201775)Nuvera Medical, Inc.2021-03-05
MI DeTACH (K210006)Biorep Technologies, Inc.2021-03-04
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 (K210324)Carefusion 2200, Inc.2021-03-04
WIRION Embolic Protection System (K210282)Cardiovascular Systems, Inc.2021-03-03
FineCross M3 (K203521)Ashitaka Factory of Terumo Corporation2021-03-03
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (K203764)Imperative Care, Inc.2021-03-03
Fingertip pulse oximeter (K202776)Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.2021-03-01
Med-Link Temp-pulse Oximeter (K202743)Shenzhen Med-Link Electronics Tech Co., Ltd.2021-03-01
Recon Support Catheter (K203275)C.R. Bard, Inc.2021-03-01
Analytic for Hemodynamic Instability (AHI) (DEN200022)Fifth Eye, Inc.2021-03-01
QardioCore (K201644)Qardio, Inc.2021-02-28
Indigo Aspiration System - Lightning Aspiration Tubing (K210323)Penumbra, Inc.2021-02-26
ASI Plethysmogrpah Analyzer (K200567)Arterial Stiffness, Inc.2021-02-26
Brite Tip Radianz Guiding Sheath (K202167)Cordis Corporation2021-02-26
Phenom Catheters (K210230)Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular2021-02-25
Triever Catheters (K210195)Inari Medical2021-02-24
ClotTriever Thrombectomy System (K210190)Irani Medical, Inc.2021-02-23
COBRA-OS Kit (K201652)Front Line Medical Technologies, Inc.2021-02-22
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire (K201720)Beijing Bywave Sensing Medical Technology Co., Ltd.2021-02-18
VIOLA (K203307)Vascular Graft Solutions, Ltd.2021-02-17
Rebar Micro Catheter (K210114)Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular2021-02-16
Extra Large Check-Flo Introducer (K203670)Cook Incorporated2021-02-16
740 SafeSAT (K200160)Zoe Medical, Inc.2021-02-15
Ezlymph, Ezlymph M (K193662)Eezcare Medical Corp2021-02-11
Meditech ABPM-06 (BP6) (K201332)Meditech , Ltd.2021-02-10
FORE-SIGHT ELITE Absolute Tissue Oximeter (K203490)Edwards Lifesciences, LLC2021-02-10
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 (K210083)Penumbra, Inc.2021-02-09
Concerto Versa, Detachable Coil (K202850)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-02-09
MouthLab Vital Signs Monitoring System (K201635)Multisensor Diagnostics (Dba Aidar Health)2021-02-06
Carnation Ambulatory Monitor (CAM) (K210036)Bardy Diagnostics, Inc.2021-02-05
Patient Monitoring Cables (K203635)Jkh USA, LLC2021-02-05
MAGIC Infusion Catheter (K202366)Balt USA, LLC2021-01-29
Michler-Kapp Cardiovascular Vent Catheter (K200289)Kapp Surgical Instrument, Inc.2021-01-28
BOSS 8F Balloon Guide Catheter (K203840)Marblehead Medical, LLC2021-01-28
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (K202892)Edan Instruments, Inc.2021-01-28
Wrist Electronic Sphygmomanometer (K193386)Shenzhen Changkun Technology Co., Ltd.2021-01-27
Arm Electronic Sphygmomanometer (K193387)Shenzhen Changkun Technology Co., Ltd.2021-01-27
Blood Pressure Monitor (K202934)Bioland Technology, Ltd.2021-01-26
VASOBand Vascular Compression Device (K203803)Vasoinnovations, Inc.2021-01-26
Pulse Oximeter (K201468)Shenzhen Creative Industry Co., Ltd.2021-01-25
Patient Monitor (K202336)Edan Instruments, Inc.2021-01-23
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform (K203131)Edwards Lifesciences, LLC2021-01-22
Overlapped Compression Therapy (K202839)Jkh Health Co., Ltd.2021-01-21
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter (K203726)Siemens Medical Solutions USA, Inc.2021-01-19
NeVa PV Thrombectomy Device (K201085)Vesalio2021-01-15
Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set (K202141)Argon Medical Devices, Inc.2021-01-15
Switched Internal Paddles (K203231)Philips North America, LLC2021-01-11
CLEWICU System (ClewICUServer and ClewICUnitor) (K200717)Clew Medical , Ltd.2021-01-09
HeartFlow Analysis (K203329)HeartFlow, Inc.2021-01-08
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 (K202405)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2021-01-07
InBody (K200560)Inbody Co., Ltd.2021-01-06
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D (K203652)Jkh USA, LLC2021-01-06
Halo Single-Loop Microsnare Kit (K200963)Argon Medical Devices, Inc.2021-01-05
Bidop 7 (K201114)Koven Technology, Inc.2021-01-05
Upper Arm Electronic Blood Pressure Monitor (K202372)Conmo Electronic Company Limited2020-12-30
M5 Recorder (K202456)Global Instrumentation, LLC2020-12-29
Bridge Occlusion Balloon (K203540)Spectranetics, Inc.2020-12-23
ReVene Thrombectomy Catheter (K201705)Vetex Medical, Ltd.2020-12-22
Serranator PTA Serration Balloon Catheter (K203437)Cagent Vascular, LLC2020-12-22
CAPERE Thrombectomy System (K203476)Vascular Medcure, Inc.2020-12-22
Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set (K201489)Argon Medical Devices, Inc.2020-12-22
Flexitouch Plus System (K203178)Tactile Systems Technology, Inc. (Dba Tactile Medical)2020-12-20
Strados Remote Electronic Stethoscope Platform (RESP) (K201077)Strados Labs2020-12-20
FlowTriever Retrieval/Aspiration System (K202345)Inari Medical2020-12-18
Wrist Type Blood Pressure Monitor (K200346)Avita Corporation2020-12-17
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (K203004)Acist Medical Systems, Inc.2020-12-17
AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter (K201081)Philips Medical System Nederland B.V.2020-12-17
Lim Precision Steerable TS, Steerable Sheath, Dilator (K202226)Keystone Heart, Ltd.2020-12-15
Columbus Guidewire (K200374)Rapid-Medical , Ltd.2020-12-14
Fingertip Pulse Oximeter (K202324)Shenzhen Bsx Technology Electronics Co., Ltd.2020-12-14
Ventrax Delivery System (K202610)Merit Medical Systems, Inc.2020-12-14
Automated ankle brachial pressure index measuring device, MESI mTABLET system (K201046)Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.2020-12-11
CorPath GRX System (K202275)Corindus, Inc.2020-12-11
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft (K202471)Peca Labs2020-12-11
Drakon and Sequre Microcatheters (K203487)Accurate Medical Therapeutics, Ltd.2020-12-11
JADE (K202231)OrbusNeich Medical (Shenzhen) Co., Ltd.2020-12-10
Triever20 Curve Catheter (K203333)Inari Medical, Inc.2020-12-10
Graffiti (K202189)Ge Medical Systems Information Technologies, Inc.2020-12-08
Biomonitor III, Biomonitor IIIm (K201865)Biotronik, Inc.2020-12-08
Impella XR Sheath Set (K202330)Abiomed, Inc.2020-12-07
B-Secur HeartKey Software Library (K200884)B-Secur , Ltd.2020-12-07
Pulse Oximeter (K201384)Shenzhen Raysintone Technology Co., Ltd.2020-12-07
Pulse Oximeter (K202173)Shenzhen AOJ Medical Technology Co., Ltd.2020-12-07
Transtek Wrist Blood Pressure Monitor (K202599)Guangdong Transtek Medical Electronics Co., Ltd.2020-12-06
DVT-2600 (K203016)Daesung Maref Co., Ltd.2020-12-05
Electronic Blood Pressure Monitor (K200716)Shenzhen Pango Electronic Co., Ltd.2020-12-04
FlowTriever Retrieval/Aspiration System (K201541)Inari Medical2020-12-04
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