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
15217–15240 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 27, 1984
STOCKERT-SHILEY INTRACARDIAC SUCKERS
K844139 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH
K844140 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 20, 1984
ACCESS & 72X ULTRASOUND SCANHEAD UM4
K843131 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 133d
Cleared Dec 20, 1984
ULTRASOUND 72X & ANNULAR ARRAY SCAN-
K843165 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 129d
Cleared Dec 19, 1984
COMPUSTRESS STRESS TESTING SYS
K842339 · DQK
Intl. Medical, Inc.
Cardiovascular · 189d
Cleared Dec 17, 1984
PACE *AID MODEL 52
K843547 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 98d
Cleared Dec 11, 1984
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654 · DSH
Del Mar Avionics
Cardiovascular · 232d
Cleared Dec 11, 1984
CARE 5000 CENTRAL MONITOR MS5220 ETC.
K842582 · DRT
Care Monitoring Systems
Cardiovascular · 161d
Cleared Dec 10, 1984
STERILE WATER
K843796
Paco Pharmaceutical Services, Inc.
Cardiovascular · 74d
Cleared Dec 07, 1984
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370 · DXH
Hewlett-Packard Co.
Cardiovascular · 175d
Cleared Dec 06, 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
K843129 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 119d
Cleared Dec 06, 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4
K843130 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 119d
Cleared Dec 04, 1984
DYNASCOPE MONITOR DS-800
K844348 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 35d
Cleared Dec 03, 1984
PULSE GENERATOR 689, 689B & 689L
K841225 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 686, 686B 686L
K841230 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 696, 696B & 696L
K841232 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Nov 29, 1984
MULTILITH 2 PULSE GENERATOR 1141 & 2141
K842220 · DXY
Ela Medical, Inc.
Cardiovascular · 177d
Cleared Nov 29, 1984
WIREGUIDE OR GUIDEWIRE
K843012 · DQX
Medi-Tech, Inc.
Cardiovascular · 121d
Cleared Nov 29, 1984
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
K843955 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 51d
Cleared Nov 27, 1984
BIPOLAR ENDOCARDIAL LEAD 406L
K841227 · DTD
Siemens Elema AB
Cardiovascular · 250d
Cleared Nov 27, 1984
SCATAID
K842706 · DXG
Sc Applied Technology, Inc.
Cardiovascular · 138d
Cleared Nov 27, 1984
LOW PROFILE STEERABLE BALLOON DILATION
K843880 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Nov 20, 1984
RECOMED CARDIAC OUTPUT METER 236067-
K840439 · DXG
Litton Medical Electronics
Cardiovascular · 293d
Cleared Nov 20, 1984
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
K840899 · DSI
Litton Medical Electronics
Cardiovascular · 266d