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
8257–8280 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 02, 2002
BIOVER
K011208 · DXC
Biover AG
Cardiovascular · 531d
Cleared Oct 01, 2002
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
K021389 · DQD
Andromed, Inc.
Cardiovascular · 152d
Cleared Oct 01, 2002
UNITY NETWORK ID
K021454 · MWI
General Electric Medical Systems...
Cardiovascular · 148d
Cleared Oct 01, 2002
QIVA
K021495 · DQK
Pie Medical Imaging BV
Cardiovascular · 145d
Cleared Oct 01, 2002
I-STETHOS LINK
K022298 · DQD
Andromed, Inc.
Cardiovascular · 77d
Cleared Oct 01, 2002
LIVESIRE ELECTROPHYSIOLOGY CATHETER
K022380 · DRF
St Jude Medical
Cardiovascular · 71d
Cleared Sep 27, 2002
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
K022115 · DTZ
Terumo Corp.
Cardiovascular · 88d
Cleared Sep 27, 2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
K022297 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 73d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · DQY
Cook, Inc.
Cardiovascular · 56d
Cleared Sep 25, 2002
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL &...
K022889 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 26d
Cleared Sep 25, 2002
CARDIS
K023015 · DQK
Schwarzer GmbH
Cardiovascular · 15d
Cleared Sep 24, 2002
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · DXO
Radi Medical Systems AB
Cardiovascular · 81d
Cleared Sep 23, 2002
STOCKERT CENTRIFUGAL PUMP CONSOLE
K020571 · DTQ
Stockert Instrumente GmbH
Cardiovascular · 214d
Cleared Sep 23, 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
K022138 · DQY
Spectranetics Corp.
Cardiovascular · 83d
Cleared Sep 20, 2002
CVSI PERIPHERAL BALLOON CATHETER
K022061 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 87d
Cleared Sep 20, 2002
CHASE CARDIOVASCULAR PATCH KIT
K022093 · DXZ
Chase Medical, Inc.
Cardiovascular · 85d
Cleared Sep 19, 2002
DISPOSABLE TEMPORARY PACING CABLE,MODELS...
K022075 · DSA
Cp Medical
Cardiovascular · 85d
Cleared Sep 19, 2002
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · KRH
St. Jude Medical, Inc.
Cardiovascular · 59d
Cleared Sep 19, 2002
DVT60
K022786 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 28d
Cleared Sep 19, 2002
PUMP TUBING WITH X-COATING
K022857 · DWE
Terumo Cardiovascular Systems...
Cardiovascular · 22d
Cleared Sep 17, 2002
M2376A DEVICELINK SYSTEM
K022920 · MWI
Philips Medical Systems
Cardiovascular · 13d
Cleared Sep 13, 2002
DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
K014141 · DXN
Digibio Technology Corp.
Cardiovascular · 270d
Cleared Sep 13, 2002
TITAN MICRO CATHETER, MODEL 105-5074-153
K022003 · DYB
Micro Therapeutics, Inc.
Cardiovascular · 86d
Cleared Sep 13, 2002
PRESS-MATE PM-2100 VITAL SIGN MONITOR
K022537 · MWI
Colin Medical Instruments Corp.
Cardiovascular · 43d