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
16945–16968 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 01, 1980
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
K801284 · DTB
Medtronic Vascular
Cardiovascular · 186d
Cleared Dec 01, 1980
SIEMENS-ELEMA PULSE GENERATOR 668
K801324 · DXY
Siemens Elema AB
Cardiovascular · 181d
Cleared Nov 26, 1980
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
K802316 · DXG
General Electric Co.
Cardiovascular · 64d
Cleared Nov 26, 1980
BIOMETRIC ERG SYSTEM
K802472 · DSI
Biometric Analysis Group, Inc.
Cardiovascular · 48d
Cleared Nov 26, 1980
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · DXK
American Edwards Laboratories
Cardiovascular · 30d
Cleared Nov 26, 1980
HP MODEL 8880A FILTER
K802686 · DRR
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Nov 26, 1980
COBE/STOCKERT BATTERY MODULE
K802714 · DWB
Cobe Laboratories, Inc.
Cardiovascular · 26d
Cleared Nov 26, 1980
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · DPS
Hewlett-Packard Co.
Cardiovascular · 26d
Cleared Nov 24, 1980
NARCO AIR-SHEILDS SYS. 100 MONITOR SYS
K802800 · DXG
Narco Air-Shields
Cardiovascular · 18d
Cleared Nov 20, 1980
RIGHT ATRIAL LINE KIT
K802287 · DQY
Stanco Medical, Inc.
Cardiovascular · 62d
Cleared Nov 20, 1980
SWAN GANZ CATHETER PLACEMENT KIT
K802288 · DYG
Stanco Medical, Inc.
Cardiovascular · 62d
Cleared Nov 19, 1980
LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN.
K792609 · DXY
Medcor, Inc.
Cardiovascular · 337d
Cleared Nov 19, 1980
SAVE MOR
K801945 · DRM
Cardia Concepts Corp.
Cardiovascular · 97d
Cleared Nov 19, 1980
CPR HELPER
K801946 · DRM
Cardia Concepts Corp.
Cardiovascular · 97d
Cleared Nov 19, 1980
CPR TRAVELER
K801947 · DRM
Cardia Concepts Corp.
Cardiovascular · 97d
Cleared Nov 19, 1980
MAPPING PROBE MODEL #6540
K802058 · DRF
Cardiac Pacemakers, Inc.
Cardiovascular · 86d
Cleared Nov 19, 1980
CHRONOCOR IV MODEL 250
K802221 · DTE
Cordis Corp.
Cardiovascular · 68d
Cleared Nov 19, 1980
CARDIACINDEX COMPUTER MODEL SP 1435
K802476 · DXG
Gould, Inc.
Cardiovascular · 41d
Cleared Nov 19, 1980
MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.
K802588 · DXY
Arco Medical Products Co.
Cardiovascular · 30d
Cleared Nov 19, 1980
THE CRITERION II PACING SYS. MONITOR
K802782 · DRT
Dart Medical Equipment
Cardiovascular · 16d
Cleared Nov 13, 1980
MEDTRONIC MODEL 6958
K800870 · DTB
Medtronic Vascular
Cardiovascular · 210d
Cleared Nov 12, 1980
CARDIOSCOPE J200
K802179 · DRS
Telectronics, Inc.
Cardiovascular · 64d
Cleared Nov 12, 1980
ATGM MODEL AT-80
K802191 · DXN
Herald of America, Inc.
Cardiovascular · 63d
Cleared Nov 12, 1980
12SSL ECG ANALYSIS PROG.(SCALER LEAD)
K802369 · LOS
Marquette Electronics, Inc.
Cardiovascular · 44d