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
16729–16752 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 12, 1981
MODELS TA 1017 & 1017T GRITIFLO DISPOS
K811538 · DRS
Gould, Inc.
Cardiovascular · 11d
Cleared Jun 09, 1981
CARDIOPLEGIA COOLING & ADMIN. SETS
K811368 · KRI
Bentley Laboratories, Inc.
Cardiovascular · 26d
Cleared Jun 09, 1981
SHILEY ARTERIAL FILTER
K811379 · DTM
Shiley, Inc.
Cardiovascular · 25d
Cleared Jun 09, 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · KRB
American Edwards Laboratories
Cardiovascular · 21d
Cleared Jun 09, 1981
THERMODILUTION KIT
K811480 · KRB
American Pharmaseal Div. Ahsc
Cardiovascular · 13d
Cleared May 29, 1981
ELA MEDICAL UNILITH PULSE GENERATOR
K810142 · DXY
Ela Medical, Inc.
Cardiovascular · 128d
Cleared May 29, 1981
MULTILITH PULSE GENERATOR #1140
K810489 · DXY
Ela Medical, Inc.
Cardiovascular · 95d
Cleared May 29, 1981
CAMPBRIDGE COMPUTRACE
K811062 · DXG
Cambridge Instruments, Inc.
Cardiovascular · 42d
Cleared May 29, 1981
CARDIOPULMONARY BYPASS ACCESSORY EQUIP.
K811348 · KRI
Bentley Laboratories, Inc.
Cardiovascular · 16d
Cleared May 27, 1981
SIRECUST 358
K803208 · DSI
Siemens Corp.
Cardiovascular · 160d
Cleared May 27, 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677 · DXY
Medtronic, Inc.
Cardiovascular · 75d
Cleared May 27, 1981
INTERMEDICS POLY FLEX ENDOCARDIAL PACING
K811106 · DTB
Intermedics, Inc.
Cardiovascular · 34d
Cleared May 27, 1981
MEDTRONIC PULSE GENERATOR
K811123 · DXY
Medtronic Vascular
Cardiovascular · 33d
Cleared May 27, 1981
INTERMEDICS CYBERLITH BIPOLAR CARDIAC
K811221 · DXY
Intermedics, Inc.
Cardiovascular · 23d
Cleared May 21, 1981
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204 · DTR
Shiley, Inc.
Cardiovascular · 20d
Cleared May 21, 1981
MODEL 1100 SPHYGMOMANOMETER
K811208 · DSK
Y
Cardiovascular · 20d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD, TINED #3262
K810396 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD-FLANGE #3260
K810397 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD, MODEL 3266
K810398 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABEL PACING LEAD, MODEL 3264
K810399 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
MODELS 8420 THRU 8423 PACEMAKER GENER
K810734 · DXY
Medtronic Vascular
Cardiovascular · 58d
Cleared May 15, 1981
CORATOMIC MODEL OVALITH-920
K810808 · DXY
Coratomic, Inc.
Cardiovascular · 52d
Cleared May 15, 1981
FOGARTY FLEXIBLE CALIBRATOR
K810894 · DWP
American Edwards Laboratories
Cardiovascular · 42d
Cleared May 15, 1981
NORELCO BLOOD PRESSURE METER
K811188 · DXN
North American Philips Corp.
Cardiovascular · 16d