FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
15817–15840 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 26, 1983
SERVOMED STANDARD SMS 104
K832041 · DRT
Litton Medical Electronics
Cardiovascular · 124d
Cleared Oct 20, 1983
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
K831458 · DWB
Electromedics, Inc.
Cardiovascular · 167d
Cleared Oct 20, 1983
TEMP. CARDIAC PACING WIRE TME 60/61/65
K831695 · LDF
Oscor, Inc.
Cardiovascular · 148d
Cleared Oct 20, 1983
LEAD INTRODUCER SETS-EB-S8 & EB-S12
K831751 · DYB
Oscor, Inc.
Cardiovascular · 141d
Cleared Oct 20, 1983
MULTIPOLAR TEMPORARY CARDIAC
K831804 · LDF
Oscor, Inc.
Cardiovascular · 139d
Cleared Oct 20, 1983
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · DYG
C.R. Bard, Inc.
Cardiovascular · 133d
Cleared Oct 20, 1983
BLOOD OXYGENATOR 5070
K831894 · DTZ
Shiley, Inc.
Cardiovascular · 128d
Cleared Oct 20, 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997 · DTB
Oscor, Inc.
Cardiovascular · 121d
Cleared Oct 20, 1983
HOLTA-MED RECORDER
K832395 · DSH
Holta-Med
Cardiovascular · 93d
Cleared Oct 20, 1983
HYPOTHERMIC MYCARDIAL PROTECTION DEV
K832417 · DTR
3M Health Care, Sarns
Cardiovascular · 91d
Cleared Oct 20, 1983
MGI STRENGTH/FITNESS SYS-MODEL #PU-101
K832528 · JOM
Mgi Strength/Fitness Systems, Inc.
Cardiovascular · 93d
Cleared Oct 20, 1983
PHYSIOLOGICAL PRESS. MEASUREMENT CATH
K832579 · DXO
Camino Laboratories, Inc.
Cardiovascular · 79d
Cleared Oct 20, 1983
PHYSIOLOGICAL PRESSURE MEASUREMENT CATH
K832604 · DXO
Camino Laboratories, Inc.
Cardiovascular · 78d
Cleared Oct 20, 1983
ULTRA LIGHT RAAF CATHETER
K832784 · DQY
Quinton, Inc.
Cardiovascular · 65d
Cleared Oct 20, 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · DTB
Pacesetter Systems
Cardiovascular · 49d
Cleared Oct 20, 1983
PURGES LINES, PL-45 & PL-33
K833048 · DTM
American Bentley
Cardiovascular · 44d
Cleared Oct 20, 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 19, 1983
VIDEO-DILUTION TECH. MARK I INSTRUMENT
K831057 · DXG
Angio Tec Corp.
Cardiovascular · 201d
Cleared Oct 19, 1983
TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO
K831245 · DXN
Ritter Co.
Cardiovascular · 184d
Cleared Oct 19, 1983
IONESCU-SHILEY LOW POROSITY COMPOSITE
K831865 · DSY
Shiley, Inc.
Cardiovascular · 131d
Cleared Oct 19, 1983
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K831880 · DSY
Shiley, Inc.
Cardiovascular · 128d
Cleared Oct 19, 1983
BLOOD OXYGENATOR 50 70/S
K831895 · DTZ
Shiley, Inc.
Cardiovascular · 127d
Cleared Oct 19, 1983
PATIENT MONITOR 788 33A
K831943 · DRT
Hewlett-Packard Co.
Cardiovascular · 125d