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Cardiovascular

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

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RecordFirmDate
Vdrive system, Vdrive Duo, Vdrive with V-Sono (K150312)Stereotaxis, Inc.2015-06-17
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Opto Wire and OptoMonitor System (K142598)Opsens, Inc.2015-06-12
Trevo XP ProVue Retriever (4x30mm) (K150616)Concentric Medical, Inc.2015-06-12
Pre-Formed Guidewire (K151244)Lake Region Medical2015-06-11
EOS PMP, EOS PMP Integrated (K150489)Sorin Group Italia S.R.L.2015-06-11
Personalized Physiology Analytics Engine software (K142512)Vgbio, Inc (Dba Physiq)2015-06-11
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] (K150373)Grandway Technology (Shenzhen) Limited2015-06-11
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD (K151260)Cardiovascular System, Inc.2015-06-10
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter (K151253)Boston Scientific Limited2015-06-10
MicroCross Catheter (K151082)Roxwood Medical, Inc.2015-06-07
IMED-Z FLUID STATUS MONITOR (K142503)Intersection Medical, Inc.2015-06-05
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter (K143041)Natec Medical , Ltd.2015-06-04
WIRION (K143570)Gardia Medical2015-06-04
Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 (K150093)Shenzhen Creative Industry Co., Ltd.2015-06-03
Cardio-TriTest (K143432)Cardio-Phoenix, Inc.2015-06-03
Occlusion Balloon Catheter (K142692)Embolx, Inc.2015-05-31
PTA 14 Balloon Dilatation Catheter OTW (K142954)Texasmedical Technologies, Inc.2015-05-28
Heavy Double Flexible Tipped Wire Guide (K150802)Cook Incorporated2015-05-28
Medtronic Patient Asistant (K150117)Medtronic, Inc.2015-05-27
Intersept Filtered Cardiotomy Reservoir (K151110)Medtronic, Inc.2015-05-27
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] (K142870)Penumbra, Inc.2015-05-26
2.4mm X 127 cm Phoenix Atherectomy Deflecting System (K151145)Volcano Atheromed, Inc.2015-05-26
Sickbay Clinical Platform (K143304)Medical Informatics Corp2015-05-26
MicroTaper Needle Introducer Set (K151076)Summit Access, LLC2015-05-22
Penumbra System ACE (K142458)Penumbra, Inc.2015-05-22
InvisionECG System (K143436)Invisionheart, Inc.2015-05-21
ELITECROSS Support Catheter (K150187)Cordis Corporation, A Johnson & Johnson Company2015-05-19
ELM PTA Balloon Dilatation Catheter (K143561)O'Connell Regulatory Consultants, Inc.2015-05-19
Datalys Multi-Parameter Patient Monitor (K150691)Lutech Industries, Inc.2015-05-15
Minhua Disposable Blood Pressure Cuff (K143728)Suzhou Minhua Medical Apparatus2015-05-15
Bookwalter Gordon Adjustable Compression Element (K143078)Symmetry Surgical2015-05-14
IntelliVue Patient Monitor (K150310)Philips Medizin Systeme Boeblingen GmbH2015-05-13
Coda LP Balloon Catheter (K150970)Cook Incorporated2015-05-12
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm (K150946)Ostial Corporation2015-05-08
Level Sensor, Level Sensor Tape (K150530)Medtronic, Inc.2015-05-08
740 SELECT (K150620)Cas Medical Systems, Inc.2015-05-08
entré Model PD08-U (K143185)Tactile Systems Technology, Inc.2015-05-07
QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators (K150267)Maquet Cardiopulmonary, AG2015-05-07
MRI PATIENT MONITORING SYSTEM TESLA M3 (K142032)Mipm Mammendorfer Institut Fur Physik Und Medizin2015-05-07
Spiral Flow Peripheral Vascular Graft (K150389)Vascular Flow Technologies, Ltd.2015-05-06
Terumo Circuit Tubing (K150536)Terumo Cardiovascular Systems Corporation2015-05-05
NovaCross Microcatheter (K143608)Nitiloop , Ltd.2015-05-04
Powerheart G5 AED (K143714)Cardiac Science Corporation2015-05-04
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (K150198)Bio-Detek, Inc.2015-05-02
OneStep Pediatric CPR Multi-Function Electrode (K150055)Bio-Detek, Inc.2015-05-02
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 (K143734)Grandway Technology (Shenzhen) Limited2015-05-02
COVA MONITORING SYSTEM (K142087)Tosense, Inc.2015-05-01
Terumo Pump Tubing (K150542)Terumo Cardiovascular Systems Corporation2015-05-01
iTClamp50 (K150813)Innovative Trauma Care, Inc.2015-04-30
Vitaphone Tele ECG Loop Recorder (K151013)Vitasystems GmbH2015-04-30
ViSi Mobile Monitoring System (K150361)Sotera Wireless, Inc.2015-04-30
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K141984)Andon Health Co, Ltd.2015-04-29
OUTBACK Elite Re-Entry Catheter (K150836)Cordis Corporation, A Johnson & Johnson Co.2015-04-29
IntraNovo 25 Microcatheter (K142817)Texasmedical Technologies, Inc.2015-04-23
PULSE OXIMETER CMS50EW (K141362)Contec Medical Systems Co.,Ltd2015-04-23
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) (K143252)Needle Tech Products, Inc.2015-04-23
Reverse Medical Micro Vascular Plug System (K150108)Reverse Medical Corporation2015-04-22
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (K150235)Boston Scientific Corporation2015-04-22
Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K143341)Microlife Intellectual Property GmbH2015-04-21
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER (K142083)C.R. Bard, Inc.2015-04-17
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor (K150430)Fudakang Industrial Co., Ltd.2015-04-17
QANS (Quantitative Autonomic Nervous System) Monitoring System (K142551)Hhssystems, LLC2015-04-16
Option (TM) ELITE Vena Cava Filter 100cm System (K143405)Rex Medical, L.P.2015-04-16
MicroCross Catheter (K143744)Roxwood Medical, Inc.2015-04-14
Fast Sphyg by Koven (K143332)Koven Technology, Inc.2015-04-14
PINPOINT GT SAFETY INTRODUCER NEEDLE (K142445)C.R. Bard, Inc.2015-04-13
Pulse Oximeter (K142687)Shanghai Berry Electronic Tech Co., Ltd.2015-04-13
Diamondback 360 Peripheral Orbital Atherectomy System (K150732)Cardiovascular Systems, Inc.2015-04-13
HEALTH KIOSK (K140360)Engagementhealth, LLC2015-04-10
FORE-SIGHT Elite Absolute Tissue Oximeter (K143675)Cas Medical Systems, Inc.2015-04-10
Chocolate PTCA Balloon Catheter (K150292)Trireme Medical, LLC2015-04-09
Prelude SNAP Splittable Sheath Introducer (K143255)Merit Medical Systems, Inc.2015-04-09
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT (K150567)Medtronic, Inc.2015-04-09
AngioSculpt PTA Scoring Baloon Catheters (K150634)Spectranetrics2015-04-08
Trevo XP ProVue Retriever (6X25mm) (K143077)Concentric Medical, Inc.2015-04-06
ELECTRONIC BLOOD PRESSURE MONITOR (K141683)Shenzhen Urion Technology Co., Ltd.2015-04-03
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular (K150262)Volcano Corporation2015-04-03
Digital Automatic Wrist Blood Pressure Monitor MD2400 (K143733)Grandway Technology (Shenzhen) Limited2015-04-03
V8 Transluminal BAV Catheter (K150343)Intervalve, Inc.2015-04-03
AWARE (K143372)Ambient Clinical Analytics2015-04-02
Disposable Blood Pressure Cuff Guard (K150227)Pinhu Sama Medical Packing Co., Ltd.2015-04-02
Euphora Rapid Exchange Balloon Dilatation Catheter (K143480)Medtronic, Inc.2015-04-02
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) (K150545)Sejoy Electronics & Instruments Co., Ltd.2015-04-02
Silk Road Acccess Catheter (K143459)Silk Road Medical, Inc.2015-04-01
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter (K150631)St Jude Medical2015-04-01
125mL CT Syringe (K142745)Coeur, Inc.2015-04-01
Ebony PTA 0.035 Peripheral Dilatation Catheter (K143036)Natec Medical , Ltd.2015-03-30
eMotion Faros ECG Mobile (K143032)Mega Electronics , Ltd.2015-03-29
samaritan PAD 450P (K142709)Heartsine Technologies, Inc.2015-03-27
SOFIA 6F Catheter (K150366)MicroVention, Inc.2015-03-27
HealthGuard-15 (K143108)Futrex, Inc.2015-03-27
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER (K141322)Cook Incorporated2015-03-27
AVERT Contrast Modulation System (K150485)Osprey Medical, Inc.2015-03-26
Headway 27 Microcatheter (K142449)MicroVention, Inc.2015-03-26
Nellcor Bedside SpO2 Patient Monitoring System (K142865)Covidien, LLC2015-03-26
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface (K143073)Medtronic, Inc.2015-03-25
Bio-Medicus Pediatric Cannula and Introducers (K143083)Medtronic, Inc.2015-03-25
EOPA 3D Arterial Cannula (K150422)Medtronic, Inc.2015-03-20
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