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
17689–17712 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 31, 1978
TENS-O-TEST
K781321
Curomatic, Inc.
Cardiovascular
Cleared Jul 28, 1978
BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902
K780622 · DTB
Medtronic Vascular
Cardiovascular · 105d
Cleared Jul 28, 1978
ENDOCARDIAL ATRIAL PACING LEAD, M. 6994
K780623 · DTB
Medtronic Vascular
Cardiovascular · 105d
Cleared Jul 28, 1978
GENERATOR, PULSE, DEMAND, MODEL 5996
K780741 · DXY
Medtronic Vascular
Cardiovascular · 88d
Cleared Jul 28, 1978
GENERATOR, PULSE MODELS 5920/5921
K780809 · DXY
Medtronic Vascular
Cardiovascular · 71d
Cleared Jul 27, 1978
GENERATOR, PULSE, CARDIAC, IMPLANTABLE
K780420 · DXY
Telectronics, Inc.
Cardiovascular · 134d
Cleared Jul 27, 1978
VENTRICULAR INHIBITED PULSE GENERATOR
K780561 · DXY
Medtronic Vascular
Cardiovascular · 111d
Cleared Jul 27, 1978
STILITH CARDIAC PACEMAKERS-M. 60 & 120
K780781 · DXY
R.E. Brown Co., Inc.
Cardiovascular · 76d
Cleared Jul 27, 1978
PROLITH 23S PACEMAKER
K781042 · DXY
Edwards Pacemaker Systems
Cardiovascular · 37d
Cleared Jul 27, 1978
LIFELINE AMBULATORY
K781054 · DPS
Imc
Cardiovascular · 36d
Cleared Jul 27, 1978
MONITOR KITS, BLOOD LEVEL
K781145 · DTW
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jul 27, 1978
WRENCH, GEXAGON, DRIVER
K781179 · DTF
Telectronics, Inc.
Cardiovascular · 13d
Cleared Jul 27, 1978
OXYGENATOR, BLOOD, INFANT/PEDIATRIC
K781223 · DTZ
Shiley, Inc.
Cardiovascular · 10d
Cleared Jul 26, 1978
LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED
K780621 · DTB
Medtronic Vascular
Cardiovascular · 103d
Cleared Jul 18, 1978
DIGITAL BLOOD PRESSURE MONITOR
K780986 · DXN
Sears, Roebuck & Co.
Cardiovascular · 34d
Cleared Jul 17, 1978
ANEROID TYPE BLOOD PRESSURE KIT
K780715 · DXQ
Mars Metal Co., Ltd.
Cardiovascular · 81d
Cleared Jul 17, 1978
PENTAX ST-1A
K780738 · DQD
Hal-Hen Co., Inc.
Cardiovascular · 76d
Cleared Jul 17, 1978
PVC QUICK PRIME LINES
K780984 · KRI
Norton Performance Plastics Corp.
Cardiovascular · 33d
Cleared Jul 07, 1978
GENERATOR, PULSE, CARDIAC, IMPLANTABLE
K780421 · DXY
Telectronics, Inc.
Cardiovascular · 114d
Cleared Jun 30, 1978
STANICOR THETA MODEL 221 CARDIAC PACER
K780453 · DXY
Cordis Corp.
Cardiovascular · 102d
Cleared Jun 30, 1978
EXTERNAL TEST PULSE GENERATOR
K780717 · DTC
Vitatron Medical BV
Cardiovascular · 64d
Cleared Jun 30, 1978
ELECTRO-PLETHYSMOGRAPH
K780761 · JOM
Biotecx Laboratories, Inc.
Cardiovascular · 52d
Cleared Jun 30, 1978
MICROPULSE 22S PACEMAKER
K780780 · DXY
Edwards Pacemaker Systems
Cardiovascular · 50d
Cleared Jun 28, 1978
SAFETY SPRING GUIDES, TEFLON COATED
K780438 · DQX
C.R. Bard, Inc.
Cardiovascular · 100d