Atlas FDA

Cardiovascular

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

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RecordFirmDate
BIOMONITOR (K132960)Biotronik, Inc.2014-06-06
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING (K140972)Medtronic, Inc.2014-06-06
ENSITE VELOCITY SYSTEM (K141050)St Jude Medical2014-06-06
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM (K141185)Boston Scientific Corp2014-06-06
AXERA 2 ACCESS SYSTEM (K140871)Arstasis, Inc.2014-06-06
HANDHELD MONITOR (K131762)Guangdong Biolight Meditech Co., Ltd.2014-06-06
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT (K141060)On-X Life Technologies, Inc.2014-06-06
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR (K140774)Terumo Cardiovascular Systems Corporation2014-06-02
ARIA WIFI SMART SCALE (K133872)Fitbit, Inc.2014-06-02
CHOCOLATE PTCA BOLLOON CATHETER (K133633)Trireme Medical, Inc.2014-06-02
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT (K141124)Vascular Flow Technologies, Ltd.2014-05-30
BODY FAT ANALYZER AND SCALE (K140594)Conmo Electronic Company Limited2014-05-30
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE (K132730)Medtronic, Inc.2014-05-30
FAMILY HEALTHWARE (K132173)Sanitas, Inc.2014-05-30
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481)St. Jude Medical, Inc.2014-05-28
TIGHTRAIL MINI (K141131)Spectranetics, Inc.2014-05-23
CORCAM HEART MONITOR (K140548)Corcam Technologia, SA2014-05-23
CARPENTIER BI-CAVAL FEMORAL CANNULA (K140192)Medtronic, Inc.2014-05-22
EV1000 CLINICAL PLATFORM (K131892)Edwards Lifesciences, LLC2014-05-22
ANS1 SOFTWARE (K140412)Ld Technology, LLC2014-05-22
ZOLL X SERIES (K133269)Zoll Medical Corporation, World Wide Headquarters2014-05-22
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR (K131588)Edwards Lifesciences, LLC2014-05-22
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT (K140151)Btg International, Inc.2014-05-21
CARDIOHELP SYSTEM (K133598)Maquet Cardiopulmonary, AG2014-05-21
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE (K140165)Medtronic, Inc.2014-05-20
DMS 300-2W HOLTER ECG RECORDER (K133014)Diagnostic Monitoring Software2014-05-19
INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT (K141015)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014-05-19
VIEWFLEX XTRA ICE CATHETER (K133853)Irvine Biomedical, Inc., A St. Jude Medical Company2014-05-19
TEMPUS PRO EXTENDED FEATURES (K133988)Remote Diagnostic Technologies , Ltd.2014-05-16
APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE (K141041)Aptus Endosystems2014-05-16
VITAL SIGNS MONITOR (K132037)Mindray North America2014-05-16
AXERA RX ACCESS SYSTEM (K140287)Arstasis, Inc.2014-05-16
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT (K140329)Boston Scientific2014-05-15
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX (K133317)Penumbra, Inc.2014-05-13
ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS (K140755)Medical Compression Systems (Dbn) , Ltd.2014-05-08
ACCUTORR 7 VITAL SIGNS MONITOR (K132038)Mindray North America2014-05-02
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 (K133064)Envitec-Wismar GmbH2014-05-02
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE (K140185)Avinger, Inc.2014-05-01
MEDTRONIC INPUT PS INTRODUCER (K132617)Medtronic, Inc.2014-04-30
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR (K133600)Coeur, Inc.2014-04-30
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) (K133882)Ge Medical Systems Information Technologies, Inc.2014-04-30
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K133879)Cas Medical Systems, Inc.2014-04-29
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER (K140733)Boston Scientific Corporation2014-04-28
FORA CARE BLOOD PRESSURE MONITORING SYSTEM (K133588)Foracare, Inc.2014-04-25
GEL-BEAD EMBOLIZATION SPHERES (K133237)Vascular Solutions, Inc.2014-04-25
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB (K140080)Codman & Shurtleff, Inc.2014-04-24
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K131525)Defibtech, LLC2014-04-24
PATIENT MONITOR (K132077)Advanced Instrumentations, Inc.2014-04-23
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K133897)Infraredx, Inc.2014-04-23
ENVOY GUIDING CATHETER (K140307)Codman & Shurtleff, Inc.2014-04-21
COMPASS CT, COMPASS CT PORT (K133624)Mirador Biomedical2014-04-18
PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) (K132075)Mindray North America2014-04-18
MCKESSON CARDIOLOGY ECG MOBILE (K133534)Mckesson Israel , Ltd.2014-04-18
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING (K133998)Angioscore, Inc.2014-04-18
FLIP INTRODUCER ACCESS KIT (K132789)Vascular Solutions, Inc.2014-04-17
DESTINO TWIST, STEERABLE GUIDING SHEATH (K140406)Oscor, Inc.2014-04-17
INITARY BETTER BLADDER-PEDIATRIC (K140321)Circulatory Technology, Inc.2014-04-17
ENCORE 26 ADVANTAGE KIT (K140745)Boston Scientific Corp2014-04-17
TRUEPATH CTO DEVICE (K140288)Boston Scientific Corp2014-04-16
INSERTION TOOL (K140673)Boston Scientific Corp2014-04-16
ROTATING ADAPTERS (K140475)Merit Medical Systems, Inc.2014-04-16
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) (K140092)Currie Medical Specialties, Inc.2014-04-16
MYHEALTHPOINT TELEHEALTH MANAGER (K132930)Entra Health Systems2014-04-14
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET (K133923)Reflectance Medical, Inc.2014-04-11
BIO-PROBE TRANSDUCER (ADULT) (K133903)Medtronic, Inc.2014-04-10
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (K140042)LeMaitre Vascular, Inc.2014-04-10
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM (K140339)Covidien2014-04-10
LEXICONTURE MECHANICAL DILATOR SHEATH SET (K140047)Spectranetics Corp.2014-04-09
HYDROPHILIC COATED GUIDEWIRE (K133155)Lake Region Medical2014-04-07
CLOUDEKG (K130878)Makromed, Inc.2014-04-04
ZOLL CODE WRITER (K132488)ZOLL Medical Corporation2014-04-03
VITALCONNECT PLATFORM BY VITAL CONNECT INC. (K132447)Vitalconnect, Inc.2014-04-03
ACUITY PRO LEAD DELIVERY SYSTEM (K132914)Boston Scientific2014-04-03
VADO STEERABLE SHEATH (K140420)Kalila Medical, Inc.2014-04-01
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM (K134044)Cardio Tek, BV2014-03-31
AXERA 2 ACCESS SYSTEM (K140201)Arstasis, Inc.2014-03-28
LEXIPLIANT DILATOR SHEATH SET (K133631)Spectranetics Corporation2014-03-27
MANDREL GUIDEWIRE (K140485)Lake Region Medical2014-03-27
TOTAL ACROSS (K133539)Medtronic Vascular2014-03-26
PEREGRINE SYSTEM INFUSION CATHETER (K140637)Ablative Solutions, Inc.2014-03-26
WITHINGS BLOOD PRESURE MONITOR (K133125)Withings2014-03-24
IM60/IM70 PATIENT MONITOR (K131971)Edan Instruments, Inc.2014-03-20
EMBOL-X INTRODUCER SHEATH (K140398)Edwards Lifesciences, LLC2014-03-19
MELYS ATRIAL FIBRILLATION SCREENING MONITOR (K132206)Advanced Fluidics, LLC2014-03-19
ASAHI GAIA FIRST, SECOND, THIRD (K133865)Asahi Intecc Co., Ltd.2014-03-18
HEALTHINTERLINK BEACON (K133252)Healthinterlink, LLC2014-03-14
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER (K140318)Biosense Webster2014-03-12
BPROSOFT CASP PC SOFTWARE (K131916)Healthstats International Pte. , Ltd.2014-03-11
ULTIMUM EV HEMOSTASIS INTRODUCER (K140327)St Jude Medical2014-03-11
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER (K140286)Cordis, A Johnson & Johnson Co.2014-03-07
CATHETER INTRODUCER SHEATH (K131627)Edwards Lifesciences, LLC2014-03-06
ANGIOVAC CANNULA (K133445)Vortex Medical, Inc.2014-03-05
CONTEC ELECTROCARDIOGRAPH (K131900)Contec Medical System Co., Ltd.2014-03-05
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII (K140208)Edwards Lifesciences, LLC2014-03-05
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES (K133619)Grandway Technology (Shenzhen) Limited2014-03-05
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES (K133618)Grandway Technology (Shenzhen) Limited2014-03-05
ANDON BLOOD PRESSURE CUFF (K133117)Andon Health Co, Ltd.2014-03-04
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE (K131788)Healthstats International Pte. , Ltd.2014-03-04
RITHM ID ELECTROPHYSIOLOGY CATHETER (K133028)Synaptic Medical Limited2014-03-04
HEM-7320 (K133383)Omron Healthcare, Inc.2014-03-04
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