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
3409–3432 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 29, 2015
Reusable Blood Pressure Cuff
K152468 · DXQ
Shenzhen Vistar Medical Supplies Co.,...
Cardiovascular · 59d
Cleared Oct 29, 2015
Disposable Blood Pressure Cuff
K152465 · DXQ
Shenzhen Vistar Medical Supplies Co.,...
Cardiovascular · 59d
Cleared Oct 29, 2015
T3 Software
K151715 · MWI
Etiometry, Inc.
Cardiovascular · 126d
Cleared Oct 28, 2015
Tempus IC2
K152124 · MWI
Remote Diagnostics Technologies, Ltd.
Cardiovascular · 89d
Cleared Oct 27, 2015
ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL...
K152801 · DXQ
Statcorp Medical
Cardiovascular · 29d
Cleared Oct 27, 2015
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value...
K152363 · DXQ
Philips Medical Systems
Cardiovascular · 68d
Cleared Oct 27, 2015
PremiPatch PTFE Pledget
K151865 · DXZ
Aesculap, Inc.
Cardiovascular · 111d
Cleared Oct 26, 2015
PolarCath Peripheral Dilatation System
K152665 · LIT
Nucyro Vascular, LLC
Cardiovascular · 39d
Cleared Oct 23, 2015
Bard Snare Retrieval Kit
K152560 · MMX
Neometrics, Inc.
Cardiovascular · 44d
Cleared Oct 23, 2015
ER-REBOA Catheter
K151821 · DQY
Pryor Medical Devices, Inc.
Cardiovascular · 109d
Cleared Oct 22, 2015
Pacel Bipolar Pacing Catheters
K152784 · LDF
St Jude Medical
Cardiovascular · 27d
Cleared Oct 22, 2015
WorkMate Claris System, WorkMate Claris System Display Plus
K151911 · DQK
St Jude Medical
Cardiovascular · 101d
Cleared Oct 22, 2015
330psi Extension Y-Line with Dual Check Valve
K150902 · DXT
Coeur, Inc.
Cardiovascular · 202d
Cleared Oct 21, 2015
ProBP 2400 Digital Blood Pressure Device
K152770 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 26d
Cleared Oct 21, 2015
HI-TORQUE BALANCE
K152709 · DQX
Abbott Vascular
Cardiovascular · 30d
Cleared Oct 21, 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K152694 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Oct 21, 2015
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels,...
K152693 · DRQ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Oct 21, 2015
Philips IntelliVue GuardianSoftware
K151736 · DXJ
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 117d
Cleared Oct 21, 2015
Oregon Scientific
K151415 · DXN
Idt Technology Limited
Cardiovascular · 147d
Cleared Oct 20, 2015
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and...
K151389 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 147d
Cleared Oct 19, 2015
Radifocus Optitorque Angiographic Catheter
K150232 · DQO
Ashitaka Factory of Terumo Corp.
Cardiovascular · 259d
Cleared Oct 16, 2015
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K152687 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 28d
Cleared Oct 15, 2015
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar...
K152633 · LDF
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Oct 15, 2015
AVERT Contrast Modulation System
K151300 · DXT
Osprey Medical, Inc.
Cardiovascular · 153d