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
16705–16728 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 27, 1981
PHYSIOLOGIC RECORDER
K810696 · DPS
Honeywell, Inc.
Cardiovascular · 11d
Cleared Mar 27, 1981
MODEL SP5107 THERMODILUTION CATHETER
K810730 · KRB
Gould, Inc.
Cardiovascular · 10d
Cleared Mar 27, 1981
MODEL IM1000 INTEGRATED MONITOR
K810731 · DQK
Gould, Inc.
Cardiovascular · 10d
Cleared Mar 27, 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · DQK
General Electric Co.
Cardiovascular · 7d
Cleared Mar 26, 1981
DATAMEDIX PECGASYS SYSTEM
K810027 · DSI
Datamedix
Cardiovascular · 80d
Cleared Mar 26, 1981
LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM
K810154 · DPS
Physio-Control Corp.
Cardiovascular · 64d
Cleared Mar 20, 1981
DUO-TEL
K810331 · DRG
General Electric Co.
Cardiovascular · 39d
Cleared Mar 20, 1981
TYPE YC ENDOCARDIAL LEAD
K810491 · DTB
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 20, 1981
TYPE YR ENDOCARDIAL LEAD
K810492 · DTB
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 20, 1981
TYPE N ENDOCARDIAL LEAD
K810493 · DTB
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 20, 1981
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K810552 · KRG
Cordis Corp.
Cardiovascular · 18d
Cleared Mar 19, 1981
DISPOSABLE PROBE FOR AQUAMATIC K-THERMIA
K810747
American Hamilton
Cardiovascular
Cleared Mar 17, 1981
CARDIOMEMO
K803286 · KRE
Instromedix, Inc.
Cardiovascular · 77d
Cleared Mar 17, 1981
SARNS TWO-STATE WIRE REINFORCED CATHETER
K810415 · DWF
3M Health Care, Sarns
Cardiovascular · 27d
Cleared Mar 17, 1981
CARDIOPULMINARY BYPASS CATHETER CANNULA
K810548 · DWF
Dlp, Inc.
Cardiovascular · 15d
Cleared Mar 17, 1981
QUINTON LTE ELECTRODE
K810563 · DRX
Quinton, Inc.
Cardiovascular · 14d
Cleared Mar 13, 1981
TEMPORARY MYOCARDIAL PACING LEAD#6400
K810333 · DTB
Medtronic Vascular
Cardiovascular · 32d
Cleared Mar 13, 1981
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386 · DXY
Intermedics, Inc.
Cardiovascular · 28d
Cleared Mar 13, 1981
CORDIS PERVENOUS ATRIAL LEAD
K810432 · DTB
Cordis Corp.
Cardiovascular · 22d
Cleared Mar 13, 1981
ELECTRODE, PACEMAKER PERMANENT
K810582 · DTB
Pacesetter Systems
Cardiovascular · 10d
Cleared Mar 11, 1981
SERIES 4000 STRESS & EXERCISE SYSTEM
K801903 · DSI
Instruments For Cardiac Research
Cardiovascular · 212d
Cleared Mar 11, 1981
HEART SENTINEL
K802900 · DSI
Totemite Medical Electronics
Cardiovascular · 114d
Cleared Mar 11, 1981
KONTRON PERCUTAEOUS DOUBLE-LUMEN
K802924 · DSP
Avco Medical Products
Cardiovascular · 113d
Cleared Mar 11, 1981
DISPOSABLE ELECTRODE FOR EKG
K803179 · DRX
Midwest Monitoring
Cardiovascular · 85d