FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
3577–3600 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 27, 2015
Medtronic Patient Asistant
K150117 · DSI
Medtronic, Inc.
Cardiovascular · 127d
Cleared May 26, 2015
2.4mm X 127 cm Phoenix Atherectomy Deflecting System
K151145 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 27d
Cleared May 26, 2015
Sickbay Clinical Platform
K143304 · MWI
Medical Informatics Corp
Cardiovascular · 189d
Cleared May 26, 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · QEW
Penumbra, Inc.
Cardiovascular · 237d
Cleared May 22, 2015
MicroTaper Needle Introducer Set
K151076 · DRE
Summit Access, LLC
Cardiovascular · 30d
Cleared May 21, 2015
InvisionECG System
K143436 · DPS
Invisionheart, Inc.
Cardiovascular · 171d
Cleared May 19, 2015
ELITECROSS Support Catheter
K150187 · PDU
Cordis Corporation, A Johnson &...
Cardiovascular · 112d
Cleared May 19, 2015
ELM PTA Balloon Dilatation Catheter
K143561 · LIT
O'Connell Regulatory Consultants, Inc.
Cardiovascular · 154d
Cleared May 15, 2015
Datalys Multi-Parameter Patient Monitor
K150691 · MWI
Lutech Industries, Inc.
Cardiovascular · 58d
Cleared May 15, 2015
Minhua Disposable Blood Pressure Cuff
K143728 · DXQ
Suzhou Minhua Medical Apparatus
Cardiovascular · 137d
Cleared May 14, 2015
Bookwalter Gordon Adjustable Compression Element
K143078 · DXC
Symmetry Surgical
Cardiovascular · 199d
Cleared May 13, 2015
IntelliVue Patient Monitor
K150310 · DSI
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 93d
Cleared May 12, 2015
Coda LP Balloon Catheter
K150970 · DQY
Cook Incorporated
Cardiovascular · 29d
Cleared May 08, 2015
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x...
K150946 · LIT
Ostial Corporation
Cardiovascular · 30d
Cleared May 08, 2015
740 SELECT
K150620 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 59d
Cleared May 08, 2015
Level Sensor, Level Sensor Tape
K150530 · DTW
Medtronic, Inc.
Cardiovascular · 67d
Cleared May 07, 2015
QUADROX-i Adult/Small Adult Oxygenators
K150267 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 92d
Cleared May 07, 2015
entré Model PD08-U
K143185 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 183d
Cleared May 07, 2015
MRI PATIENT MONITORING SYSTEM TESLA M3
K142032 · MWI
Mipm Mammendorfer Institut Fur Physik...
Cardiovascular · 286d
Cleared May 06, 2015
Spiral Flow Peripheral Vascular Graft
K150389 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 77d
Cleared May 05, 2015
Terumo Circuit Tubing
K150536 · DWF
Terumo Cardiovascular Systems...
Cardiovascular · 63d
Cleared May 04, 2015
Powerheart G5 AED
K143714 · MKJ
Cardiac Science Corporation
Cardiovascular · 126d
Cleared May 04, 2015
NovaCross Microcatheter
K143608 · DQY
Nitiloop , Ltd.
Cardiovascular · 136d
Cleared May 02, 2015
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
K150198 · MKJ
Bio-Detek, Inc.
Cardiovascular · 93d