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
17545–17568 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 10, 1978
HEAT EXCHANGER, FHX-14
K781210 · DTR
Delta Medical Industries
Cardiovascular · 85d
Cleared Oct 10, 1978
SURGITEK DISPOSABLE FLO-RESTER
K781336 · DWS
Medical Engineering Corp.
Cardiovascular · 68d
Cleared Oct 10, 1978
PRESSURE MONITORING INJECTION LINES
K781558 · DQO
Cobe Laboratories, Inc.
Cardiovascular · 29d
Cleared Oct 06, 1978
PRINTER, DIGITAL
K781115 · DSF
Output, Inc.
Cardiovascular · 95d
Cleared Oct 06, 1978
PREGELLED DISPOSABLE ELECTRODE
K781518 · DRX
Vente Medical Products, Inc.
Cardiovascular · 36d
Cleared Oct 06, 1978
MONITORING, PRESSURE KIT
K781680 · DRS
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular · 4d
Cleared Oct 05, 1978
MODIFIED STERILE DISPOSABLE STOPCOCKS
K781579 · DTL
Cobe Laboratories, Inc.
Cardiovascular · 20d
Cleared Oct 03, 1978
ARCOBIOLITH PACEMAKER MODEL
K780776 · DXY
Arco Medical Products Co.
Cardiovascular · 148d
Cleared Oct 03, 1978
GENERATORS, PULSE, MODELS 5988/5989
K781208 · DXY
Medtronic Vascular
Cardiovascular · 81d
Cleared Oct 03, 1978
GENERATOR, PULSE, MODEL 5997
K781252 · DXY
Medtronic Vascular
Cardiovascular · 74d
Cleared Sep 27, 1978
PACEMAKER, MODEL 225 & 227
K772226 · DXY
Intermedics, Inc.
Cardiovascular · 295d
Cleared Sep 27, 1978
GENERATOR, PULSE, MODEL 160B
K780940 · DXY
Telectronics, Inc.
Cardiovascular · 111d
Cleared Sep 27, 1978
AIR BUBBLE DETECTOR
K781021
3M Health Care, Sarns
Cardiovascular · 100d
Cleared Sep 27, 1978
INTERFACE CARDIOTOMY BLOOD FILTER
K781383 · JOD
Medical, Inc.
Cardiovascular · 47d
Cleared Sep 27, 1978
ERM-101
K781407 · DRT
Cynergy
Cardiovascular · 44d
Cleared Sep 27, 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
K781424 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Sep 27, 1978
DISPOSABLE CARDIOTOMY
K781577 · DTN
C.R. Bard, Inc.
Cardiovascular · 12d
Cleared Sep 26, 1978
ELECTRODE, DEIP.
K781163 · DRX
Datascope Corp.
Cardiovascular · 76d
Cleared Sep 20, 1978
DIGITAL PANEL METER
K781255 · DRT
Rae Medical Corp.
Cardiovascular · 61d
Cleared Sep 20, 1978
CATHODE RAY TUBE MED. DISPLAY
K781256 · DXJ
Rae Medical Corp.
Cardiovascular · 61d
Cleared Sep 20, 1978
CARDIOPNEUMOGRAPH
K781292 · DRT
Street Electronics Corp.
Cardiovascular · 57d
Cleared Sep 20, 1978
T.E.D. SEQUENTIAL COMPRESSION SLEEVES
K781357 · JOW
Kendall Research Center
Cardiovascular · 43d
Cleared Sep 20, 1978
SEQUENTIAL CUFF INFLATION DEVICE
K781358 · JOW
Medasonics, Inc.
Cardiovascular · 43d
Cleared Sep 20, 1978
INSTA-PULSE HEART RATE MONITOR
K781387 · DRT
Bio Sig Instruments, Inc.
Cardiovascular · 41d