FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15961–15984 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 24, 1983
ECLIPSE
K830407 · DSI
Diagnostic Medical Instruments
Cardiovascular · 45d
Cleared Mar 24, 1983
CENTRAL STATION 590
K830432 · DRT
Kone Instruments, Inc.
Cardiovascular · 43d
Cleared Mar 24, 1983
PATIENT MONITOR 575
K830433 · DRT
Kone Instruments, Inc.
Cardiovascular · 43d
Cleared Mar 24, 1983
KELLY-WICK TANNELER
K830471 · DWS
Intl. Medical Prosthetics Research
Cardiovascular · 37d
Cleared Mar 24, 1983
USCI GRUNTZIG DILACA BALLOON DILATION
K830608 · LIT
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Mar 24, 1983
INFLATION DEVICE
K830609 · DXT
Interventional Medical, Inc.
Cardiovascular · 27d
Cleared Mar 24, 1983
VERTEX DIGITAL SUBSTRATION KIT
K830637 · DQO
Professional Medical Services
Cardiovascular · 23d
Cleared Mar 17, 1983
THERACARD 400
K823828 · LDD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 87d
Cleared Mar 17, 1983
HEARTRATE PLUS ECG CARDULE #1918
K830306 · DSI
Spacelabs, Inc.
Cardiovascular · 45d
Cleared Mar 17, 1983
COMMAND ULTRA II
K830382 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 41d
Cleared Mar 17, 1983
UNILITH PULSE GENERATOR VVI #7542
K830401 · DXY
Ela Medical, Inc.
Cardiovascular · 38d
Cleared Mar 17, 1983
PACING LEAD #PMA F 860
K830457 · DTB
Ela Medical, Inc.
Cardiovascular · 36d
Cleared Mar 17, 1983
LYMPHANGIOGRAPHY SET
K830576 · DQO
Vertex Medical Corp.
Cardiovascular · 22d
Cleared Mar 16, 1983
MEDTRONIC MODELS 59401 5941
K823831 · DXY
Medtronic Vascular
Cardiovascular · 85d
Cleared Mar 16, 1983
PACEMAKER ELECTRODE PERM. & TEMP
K830464 · DTB
Daig Corp.
Cardiovascular · 29d
Cleared Mar 16, 1983
CATHETER CONNECTION W/INTEGRAL INJECTATE
K830523 · DQO
Gould, Inc.
Cardiovascular · 27d
Cleared Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · DQO
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Mar 11, 1983
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
K830167 · KRI
American Bentley
Cardiovascular · 52d
Cleared Mar 10, 1983
PATCH
K823345 · DXZ
Shiley, Inc.
Cardiovascular · 122d
Cleared Mar 10, 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · DXY
Intermedics, Inc.
Cardiovascular · 78d
Cleared Mar 10, 1983
MICRO FITNESS COMPUTER
K830003 · DXG
Microfit, Inc.
Cardiovascular · 66d
Cleared Mar 09, 1983
TELEMETRY SYSTEM
K823906 · DRG
Transkinetic Systems, Inc.
Cardiovascular · 71d
Cleared Feb 28, 1983
EPI CARDIA SYS. - AMBULATORY MONITOR
K830013 · DSI
Medicomp, Inc.
Cardiovascular · 56d
Cleared Feb 28, 1983
VEINPREP VEIN GRAFT PREP. KIT A277723
K830150 · DWD
Atrium Medical Corp.
Cardiovascular · 42d