Atlas FDA

Cardiovascular

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (K113845)Medtronic, Inc.2012-01-25
GENESIS TOUCH SYSTEM (K112858)Honeywell Hommed, LLC2012-01-24
MICROFRANCE(R) WORMALD VASCULAR CLAMP (K112662)Medtronic Xomed, Inc.2012-01-20
DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
GPSCATH BALLON DILATATION CATHETER (K113769)Hotspur Technologies2012-01-20
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR (K113083)Truly Instrument Co., Ltd.2012-01-19
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) (K120010)Shenzhen Med-Link Electronics Tech Co., Ltd.2012-01-19
HANDHELD PULSE OXIMETER (K111494)Beijing Choice Electronic Technololgy Co., Ltd.2012-01-18
AVITA ARM TYPE BLOOD PRESSURE MONITOR (K112825)Avita Corporation2012-01-18
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL (K113773)St Jude Medical2012-01-18
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL (K113101)Boston Scientific Corporation2012-01-17
THE VENOUS ASSIST SYSTEM (K112677)Daesung Maref Co., Ltd.2012-01-13
SCEPTER XC OCCLUSION BALLOON CATHETER (K113698)MicroVention, Inc.2012-01-13
FUNNEL GUIDE CATHETER MODEL G1020608 (K102439)Lazarus Effect, Inc.2012-01-12
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR (K113085)Truly Instrument Co., Ltd.2012-01-12
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING (K113667)Edwards Lifesciences, LLC2012-01-12
GLADIATOR PTA BALLOON DILATION CATHETER (K113681)Boston Scientific2012-01-11
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K113651)Boston Scientific Corporation2012-01-11
SONOTT FLOWLAB(R) (K111730)Em-Tec GmbH2012-01-06
VALET MICRO CATHETER (K112035)Volcano Corporation2012-01-05
NMI 2.8 MICROCATHETER (K113638)Navilyst Medical, Inc.2012-01-05
AVIVO MOBILE PATIENT MANAGEMENT (K113187)Corventis, Inc.2012-01-04
BIGBOSS CATHETER (K113589)Bridgepoint Medical2012-01-04
MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES (K111403)Masimo Corporation2011-12-30
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME (K111159)Cardiocomm Solutions, Inc.2011-12-22
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 (K111617)Acare Technology Co., Ltd.2011-12-22
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM (K112216)Taidoc Technology Corporation2011-12-22
AUREFLO MONITORING SYSTEM (K112657)Transonic Systems, Inc.2011-12-21
MYSENSE HEART (K113176)Cardiac Science Corporation2011-12-21
FUKUDA DENSHI VASERA MODEL VS-1500 (K112521)Fukuda Denshi USA, Inc.2011-12-21
TCX-I REMOTE CARE MANAGEMENT SYSTEM (K113493)Bl Healthcare, Inc.2011-12-21
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM (K112274)Taidoc Technology Corporation2011-12-21
ELM PTA BALLON DILATATION CATHETER (K113468)Creagh Medical, Ltd.2011-12-20
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, (K112587)Terumo Cardiovascular Systems Corp.2011-12-19
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) (K110603)I.E.M. GmbH2011-12-16
TEMPUSIC PATIENT MONITOR (K113105)Remote Diagnostic Technologies , Ltd.2011-12-15
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE (K113133)Medrad, Inc.2011-12-15
SMI CARDIOVASCULAR PACH (K112683)Solimas Medical, Inc.2011-12-14
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) (K111738)Trireme Medical, Inc.2011-12-14
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST (K112203)Mirador Biomedical, Inc.2011-12-14
TERUMO ASPRIATION CATHETER (K112382)Terumo Medical Corporation2011-12-14
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO (K111830)Andon Health Co, Ltd.2011-12-09
ATB ADVANCE PTA DILATATION CATHETER (K113300)Cook, Inc.2011-12-09
SARN CENTRIFUGAL PUMP (K112229)Terumo Cardiovascular Systems2011-12-09
NETKONNECT REMOTE NETWORK EXTENSION (K112637)Nihon Kohden2011-12-09
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER (K112513)Natec Medical , Ltd.2011-12-09
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K111826)Andon Health Co, Ltd.2011-12-09
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K113182)Edwards Lifesciences, LLC2011-12-07
NOVAPORT ONE VASCULAR ACCESS CANNULA (K112565)Novalung GmbH2011-12-06
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K112845)Microlife Intellectual Property GmbH2011-12-05
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 (K113213)Biosense Webster, Inc.2011-12-05
VOCARE MYHEALTH TABLET (K111922)Vocare, Inc.2011-12-02
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS (K113235)Medtronic, Inc.2011-12-02
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM (K112559)Medapps, Inc.2011-12-02
ANGIOJET ULTRA DVX THROMBECTOMY SET (K113428)Medrad, Inc.2011-12-02
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE (K112979)Asahi Intecc Co., Ltd.2011-12-01
GUIDELINER V2 CATHETER (K112082)Vascular Solutions, Inc.2011-12-01
CHARGER PTA BALLON DILATATION CATHETER (K112697)Boston Scientific2011-11-30
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML (K113198)Navilyst Medical, Inc.2011-11-28
HOTDOG PATIENT WARMING SYSTEM (K112488)Augustine Biomedical & Design, LLC2011-11-23
RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A (K111748)Joy Long2011-11-23
VITALOGRAPH MODEL 7100 - VITALOJAK (K110525)Vitalograph (Ireland) , Ltd.2011-11-23
PENUMBRA SYSTEM MAX (K113163)Penumbra, Inc.2011-11-23
VTRUST FINGER TYPE PULSE OXIMETER (K110893)Taidoc Technology Corporation2011-11-22
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K112270)Accumed Healthcare (Shanghai), Inc.2011-11-22
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR (K112273)Accumed Healthcare (Shanghai), Inc.2011-11-22
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM (K112647)Wistron Corporation2011-11-22
UNIMED BLOOD PRESSURE CUFF (K112544)Unimed Medical Supplies, Inc.2011-11-22
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES (K112687)Welch Allyn, Inc.2011-11-22
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE (DEN100026)Aptus Endosystems, Inc.2011-11-21
TAPAS CATHETER (K112219)Thermopeutix, Inc.2011-11-18
TRANSRADIAL ARTERY ACCESS DEVICES (K112554)Teleflexmedical, Inc.2011-11-18
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER (K112050)Biosense Webster, Inc.2011-11-18
INTELLIVUE MX40 PATIENT MONITOR (K113125)Philips Medical Systems2011-11-17
MOBCARDIO SYSTEM (K113234)Mobhealth Incorporation2011-11-17
CLEARWAY RX NB CATHETER (K113112)Atrium Medical Corp.2011-11-17
HEALTHTRACKER (K110770)Wistron Corporation2011-11-16
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (K111773)Renu Medical, Inc.2011-11-16
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (K111487)Norav Medical Corp.2011-11-10
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) (K110463)Norav Medical , Ltd.2011-11-10
MULTIFUNCTION KEITO (K103058)Aguiflai Iberica S.L.2011-11-10
NEXGEN EXPANDABLE CATHETER (K102925)Nexgen Medical Systems, Inc.2011-11-10
VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS (K112838)Compression Therapy Concepts, Inc.2011-11-10
RUBICON SUPPORT CATHETER (K112303)Boston Scientific2011-11-09
AXERA ACCESS SYSTEM (K113110)Arstasis, Inc.2011-11-09
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER (K112601)Intricon Datrix Corporation2011-11-09
ENSITE VELOCITY SYSTEM V.3.0 (K112688)St Jude Medical2011-11-09
POWERPRESS UNIT (K110276)Hanuri Distribution, Inc.2011-11-09
PATIENT MONITOR (K112190)Mediana Co., Ltd.2011-11-09
HI-TORQUE POWERTURN (K112957)Abbott Vascular-Cardiac Therapies2011-11-08
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (K100811)ImpediMed Limited2011-11-04
M VISUM ALERT ALARM MANAGEMENT SYSTEM (K112282)Mvisum, Inc.2011-11-04
HI TORQUE CONNECT GUIDEWIRE (K112381)Lake Region Medical2011-11-03
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) (K112962)Spacelabs Medical, Inc.2011-11-02
REFLEX BALLON GUIDE CATHETER (K112262)Reverse Medical Corporation2011-11-02
FOURSNARE VASCULAR RETRIEVAL SNARE (K112185)Cook, Inc.2011-11-02
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI (K102378)Vectracor, Inc.2011-11-02
BODY ANALYSIS SCALE (K112951)Shenzhen Healthcare Electronic Technology Co., Ltd.2011-11-01
TRANSTEK (K112932)Zhongshan Transtek Electronics Co., Ltd.2011-11-01
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K111693)Philips Medical Systems2011-10-28
← Previous Next →

Track Cardiovascular automatically

Every clearance here is in the API, with alerts when new ones post.