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
17233–17256 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 11, 1980
AMP DIRECT VASCULAR MONITORING SYSTEM
K792646 · KRH
American Medical Products, Inc.
Cardiovascular · 52d
Cleared Feb 11, 1980
TRANSDUCER
K800093
Kt Medical, Inc.
Cardiovascular · 28d
Cleared Feb 11, 1980
INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR
K800179 · DXW
Sphygmetrics, Inc.
Cardiovascular · 13d
Cleared Feb 11, 1980
OVALITH P-BP BIPOLAR CARDIAC PACEMAKER
K800194 · DXY
Coratomic, Inc.
Cardiovascular · 13d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792451 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792452 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792454 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC TEST SET, PT.#500-A250
K792458 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PULSE GENERATOR, MODEL NO. LIT 222
K792526 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
SORIN PULSE GENERATOR MODEL # LIT 214 H
K792565 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
TRANSCUTANEOUS OXYGEN MONITOR
K800073
Biochem International, Inc.
Cardiovascular · 22d
Cleared Feb 05, 1980
BRIOX MODEL-AEROMIST
K800078
Briox Technologies, Inc.
Cardiovascular · 22d
Cleared Feb 01, 1980
DINAMAP RESEARCH MONITOR 1245
K800025 · DXN
Applied Medical Research
Cardiovascular · 25d
Cleared Feb 01, 1980
HANCOCK AORTIC PUNCH
K800122 · DWS
Hancock Laboratories, Inc.
Cardiovascular · 14d
Cleared Feb 01, 1980
CARDIOPLEGIA ADMINISTRATION SYSTEM CAS
K800135 · KRJ
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Feb 01, 1980
DIAGNOSTIC INTRAVASCULAR CATHETER
K800171 · DQO
Flomed, Inc.
Cardiovascular · 7d
Cleared Jan 31, 1980
PACING SYSTEM ANALYZER PSA SCE-22
K791975 · DTC
Ela Medical, Inc.
Cardiovascular · 121d
Cleared Jan 31, 1980
CYNERGY MODEL 182
K792536 · DTE
Cynergy
Cardiovascular · 55d
Cleared Jan 31, 1980
MICROTHIN-DI
K800026 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 31, 1980
MICROTHIN-PI
K800027 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 29, 1980
PACEMAKER ELECTRODE INSERTER AIDE
K800088 · DTE
Telectronics, Inc.
Cardiovascular · 15d
Cleared Jan 24, 1980
NIC-200 VENTRICULAR FUNCTION ANALYZER
K792466 · DQC
Nicolet Biomedical Instruments
Cardiovascular · 52d
Cleared Jan 23, 1980
CARDIASSIST EXTERNAL COUNTERPULSATION
K792430 · DRN
Cardiassist Corp.
Cardiovascular · 57d
Cleared Jan 17, 1980
SONACOLOR 6000
K792540 · DXK
Carolina Medical Electronics
Cardiovascular · 38d