Atlas FDA

Cardiovascular

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

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RecordFirmDate
SUMMED HIGH PRESSURE LINE (K140356)Sunny Medical Device (Shenzhen) Co., Ltd.2015-03-20
Vyntus Walk (K142959)Carefusion Germany 234 GmbH2015-03-20
FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR (K141460)Finapres Medical Systems B.V.2015-03-20
IS4/DF4 Port Plug (K143463)Oscor, Inc.2015-03-19
BioMonitor (K143503)Biotronik, Inc.2015-03-19
Assurance Alar / Nasal SpO2 Sensor (K143216)Xhale, Inc.2015-03-17
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (K150030)Fukuda Denshi USA, Inc.2015-03-16
CardiacLinx (K142352)Ross Medical Technology, Inc.2015-03-12
Attain Hybrid Guide Wire (K143316)Medtronic, Inc.2015-03-11
ASAHI FUBUKI 043 / ASAHI FUBUKI (K141981)Asahi Intecc Co., Ltd.2015-03-09
QuantaFlo (K143094)Semler Scientific, Inc.2015-03-05
MASTRO PLUS BALLOON IN-DEFLATION DEVICE (K140943)Beijing Demax Medical Technology Co.,Ltd2015-03-05
FOXTROT NC PTCA Balloon Catheter (K143160)Shanghai MicroPort Medical (Group) Co., Ltd.2015-03-05
Nellcor Bedside Respiratory Patient Monitoring System (K141518)Covidien2015-03-05
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating (K142983)Angioscore, Inc.2015-03-04
T3 Software (K142732)Etiometry, Inc.2015-03-04
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath (K150360)Spectranetics, Inc.2015-03-04
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter (K150201)Spectranetics, Inc.2015-02-27
Vector PTA Balloon Dilatation Catheter (K143652)Vector Corporation, LLC2015-02-26
Fingertip Pulse Oximeter (K142888)Beijing Choice Electronic Technololgy Co., Ltd.2015-02-20
ZywieAI Software Library (K142693)Zywie, Inc.2015-02-20
Spring Coil Guidewire (K143135)Neometrics, Inc.2015-02-20
BODY COMPOSITION ANALYZER (K140045)Jawon Medical Co., Ltd.2015-02-18
Medtronic Model 5392 External Pulse Generator (EPG) (K150246)Medtronic, Inc.2015-02-18
Master Caution Device MCD (K142476)Healthwatch , Ltd.2015-02-17
DIGITAL ELECTROCARDIOGRAPH (K141946)Shenzhen Biocare Bio-Medical Equipment Co., Ltd.2015-02-13
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR (K134046)Fukuda Denshi USA, Inc.2015-02-12
ENROUTE Transcarotid Neuroprotection System (K143072)Silk Road Medical, Inc.2015-02-09
ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) (K141492)Eurosets S.R.L2015-02-06
Unimed Disposable and Reusable SPO2 Sensors (K142832)Unimed Medical Supplies, Inc.2015-02-06
CLEO PATIENT MONITOR (K142244)Infinium Medical2015-02-06
12SL ECG ANALYSIS PROGRAM (K141963)Ge Medical Systems Information Technologies, Inc.2015-02-05
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE (K141516)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2015-02-05
Infusion Aspiration Catheter System (K143563)Inari Medical, Inc.2015-02-03
Ebony PTA 0.014 RX Peripheral Dilatation Catheter (K142459)Natec Medical , Ltd.2015-02-03
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR (K141751)Asahi Intecc Co., Ltd.2015-01-30
VECTRAPLEX CMS (K140852)Vectracor, Inc.2015-01-30
NAVAJO PTA BALLOON DILATATION CATHETER (K141354)Curative Medical, Inc.2015-01-30
One Way Soft Valve (K142500)Terumo Cardiovascular Systems Corporation2015-01-29
TRANSONIC ELSA SYSTEM (K134051)Transonic Systems, Inc.2015-01-29
AliveCor Heart Monitor (K142743)AliveCor, Inc.2015-01-27
CROC (K141685)Combat Medical Systems, LLC2015-01-26
Benchmark Intracranial Access System (K142321)Penumbra, Inc.2015-01-26
Visi Mobile Monitoring System (K143751)Sotera Wireless, Inc.2015-01-23
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (K133659)Philips Medical Systems2015-01-23
DIGITAL ELECTROCARDIOGRAPH (K133985)Shenzhen Biocare Bio-Medical Equipment Co., Ltd.2015-01-22
Deltex Medical KDP72 Doppler Probe (K142932)Deltex Medical Limited2015-01-22
ULTRASKIN HYDROPHILIC GUIDE WIRE (K141707)Lepu Medical Technology (Beijing) Co., Ltd.2015-01-21
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (K143317)Currie Medical Specialties, Inc.2015-01-20
DECISIO HEALTH PATIENT DASHBOARD (K142106)Decisio Health, Inc.2015-01-18
TruWave Disposable Pressure Transducer (K142749)Edwards Lifesciences, LLC2015-01-18
Pulse oximeter NBM-200 (K142209)Orsense, Ltd.2015-01-16
ZOLL E SERIES (K133239)Zoll Medical Corporation, World Wide Headquarters2015-01-16
Medline ReNewal Reprocessed Compression Limb Sleeves (K143166)Surgical Instrument Service and Savings (Dba Medline Renewal2015-01-16
SUPER SHEATH (K141070)Togo Medikit Co., Ltd.2015-01-15
CareEvent (K142935)Philips Medical Systems2015-01-15
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (K143587)Boston Scientific Corporation2015-01-15
ADROIT Guiding Catheter (K143412)Cordis Corporation2015-01-14
EXTERNAL PULSE OXIMETER (K141024)Beijing Choice Electronic Technololgy Co., Ltd.2015-01-13
Surefire Infusion System 021 (K143588)Surefire Medical, Inc.2015-01-12
Presto Inflation Device (K143522)C.R. Bard, Inc.2015-01-12
CARDIOGARD EMBOLI PROTECTION CANNULA (K141465)Cardiogard Medical, Ltd.2015-01-09
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (K133130)Cook, Inc.2015-01-09
MENNTOR X7 (K141441)Mennen Medical , Ltd.2015-01-09
IntellaMap Orion High Resolution Mapping Catheter (K143481)Rhythmia Medical, Inc.2015-01-08
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (K142447)Synovis Life Technologies, Inc.2015-01-07
ENDOPHYS BLOOD PRESSURE MONITOR (K141615)Endophys, Inc.2015-01-07
Unity Network ID (K142840)GE Healthcare2015-01-07
ENDOPHYS PRESSURE SENSING SHEATH KIT (K141275)Endophys, Inc.2015-01-07
DLP Vein Graft Cannula (K143107)Medtronic, Inc.2015-01-07
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (K143195)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014-12-22
Carnation Ambulatory Monitor (K143067)Bardy Diagnostics, Inc.2014-12-22
Passage Hemostasis Valve (K143429)Merit Medical Systems, Inc.2014-12-22
Full Automatic (NIBP) Blood Pressure Monitor (K142968)Health & Life Co., Ltd.2014-12-19
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (K143328)Volcano Atheromed, Inc.2014-12-19
Connex Spot Monitor,901058 Vital Signs Monitor Core (K142356)Welch Allyn, Inc.2014-12-19
RhythmView Workstation (K142901)Topera, Inc.2014-12-19
LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) (K132407)Lifewatch Technologies , Ltd.2014-12-19
Hi-Torque JET Guide Wire Family (K142415)Abbott Vascular, Inc.2014-12-19
FIRSTSTIC N INTRODUCER (K141969)Argon Medical Devices, Inc.2014-12-19
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS (K141530)Stereotaxis, Inc.2014-12-18
CPS Direct MediGuide Enabled outer catheter (K142239)St Jude Medical2014-12-18
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter (K142235)St Jude Medical2014-12-18
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM (K141218)Vadiswire Corporation2014-12-18
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (K142702)Medivance, Inc.2014-12-18
AMIGO REMOTE CATHETER SYSTEM (DEN140009)Catheter Robotics, Inc.2014-12-18
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE (K140536)Lake Region Medical2014-12-17
NANOSTIM INTRODUCER KIT (K140793)St. Jude Medical, Inc.2014-12-17
PRELUDE PLASTIC JACKETED GUIDE WIRE (K142051)Merit Medical Systems, Inc.2014-12-17
MERIT HYDROPHILIC GUIDEWIRE (K141295)Merit Medical Systems, Inc.2014-12-16
Phlebo Press DVT 603 (K142772)Mego Afek AC , Ltd.2014-12-16
TELESENSE (K142180)Scottcare Corporation2014-12-12
SUMMED INFLATION DEVICE KIT (K133795)Sunny Medical Device (Shenzhen) Co., Ltd.2014-12-12
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES (K142081)Osprey Medical, Inc.2014-12-12
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION (K141756)Draeger Medical Systems, Inc.2014-12-12
AngioVac Circuit (K142607)Angiodynamics2014-12-11
DISTAL ACCESS TORQUE DEVICE (K141054)Distal Access, LLC2014-12-10
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit (K143208)C.R. Bard, Inc.2014-12-09
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (K141795)R & D Batteries, Inc.2014-12-08
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