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
17329–17352 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 12, 1979
SWAN-GANZ FLOW-DIRECTED CATHETER
K791183 · LDF
Edwards Lifesciences, LLC
Cardiovascular · 17d
Cleared Jul 10, 1979
BIFLEX TM TEMPORARY PACING PROBE
K790983 · DTB
Advanced Medical Concepts, Inc.
Cardiovascular · 46d
Cleared Jul 10, 1979
HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC
K791054 · DXN
C.R. Bard, Inc.
Cardiovascular · 33d
Cleared Jul 10, 1979
PREGELLED DISPOSABLE ECG ELECTRODES
K791139 · DRX
Hayes Products, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
PREGELLED DISPOSABLE EELCTRO. SERIES 600
K791140 · DRX
Hayes Products, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
CPR CONTROL SYSTEM
K791145 · DRM
Pepin Distributing, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
ARCOLITH 4000
K791165 · DXY
Arco Medical Products Co.
Cardiovascular · 15d
Cleared Jul 05, 1979
MEDTRONIC MODEL 6957
K790429 · DTB
Medtronic Vascular
Cardiovascular · 125d
Cleared Jun 27, 1979
PULSE GENERATOR MODEL 629
K790670 · DXY
Elema-Schonander, Inc.
Cardiovascular · 82d
Cleared Jun 22, 1979
DYNAJECT
K790835 · DXT
Atomic Products Corp.
Cardiovascular · 53d
Cleared Jun 22, 1979
APOLLO HEART RATE INDICATOR
K790999 · JOM
Apollo Products, Inc.
Cardiovascular · 24d
Cleared Jun 22, 1979
4F STERILE BALLOON-LESS, CATHETER 913-28
K791026 · KRB
Waters Assoc., Inc.
Cardiovascular · 18d
Cleared Jun 22, 1979
SINGLE-USE MINI-BULLDOG
K791098 · DXC
Med General
Cardiovascular · 10d
Cleared Jun 22, 1979
STOPCOCK, THREE WAY
K791107 · DTL
Norton Performance Plastics Corp.
Cardiovascular · 8d
Cleared Jun 20, 1979
MODELS 2411/2418 VENTRICULAR-INHIBITED
K791093 · DXY
Medtronic Vascular
Cardiovascular · 8d
Cleared Jun 13, 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
K790938 · DWP
Shiley, Inc.
Cardiovascular · 26d
Cleared Jun 11, 1979
AORTIC ROOT CANNULA
K790565 · DWF
Dlp, Inc.
Cardiovascular · 84d
Cleared Jun 11, 1979
HEAT EXCHANGER COIL
K790756 · DTR
Delta Medical Industries
Cardiovascular · 55d
Cleared Jun 11, 1979
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
K790838 · DXE
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 11, 1979
LEAD INTRODUCER SET
K790882 · DQX
Introstat
Cardiovascular · 34d
Cleared Jun 11, 1979
MODEL 78501A PATIENT MONITORING SYSTEM
K790939 · DPS
Hewlett-Packard Co.
Cardiovascular · 24d
Cleared Jun 11, 1979
MODEL 6971 W/ DBS WIRE
K790988 · DTB
Medtronic Vascular
Cardiovascular · 17d
Cleared Jun 11, 1979
SMART BILECTRODES
K791006 · DRX
Electronics For Medicine, Inc.
Cardiovascular · 11d
Cleared Jun 06, 1979
STRESS TESTING SYSTEM, LATERAL TILTING
K790545 · DRT
Engineering Dynamics Corp.
Cardiovascular · 78d