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
17041–17064 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 09, 1980
ELECTROCARDIOGRAPH ELECTRODE
K801846 · DRX
Phoenix Glove Co.
Cardiovascular · 36d
Cleared Sep 09, 1980
HANCOCK * OBTURATORS
K801885 · DTI
Hancock Laboratories, Inc.
Cardiovascular · 33d
Cleared Sep 09, 1980
INSULATING SHEATH
K801910 · DXY
Cordis Corp.
Cardiovascular · 29d
Cleared Sep 09, 1980
BIO-MED CORP. DISP. NON-STERILE TRANSDU
K801985 · DRS
Bio-Med Corp.
Cardiovascular · 21d
Cleared Sep 09, 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · DXY
Intermedics, Inc.
Cardiovascular · 29d
Cleared Sep 09, 1980
DISP. TRANSDUCER DOMES TD200 & TD300
K802069 · DRS
Bio-Med Corp.
Cardiovascular · 13d
Cleared Sep 06, 1980
PA-1 LOW PRESSURE ALARM
K802112
Puritan Bennett Corp.
Cardiovascular · 3d
Cleared Aug 27, 1980
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.
K801637 · KPK
C.R. Bard, Inc.
Cardiovascular · 41d
Cleared Aug 27, 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762 · DSI
General Electric Co.
Cardiovascular · 30d
Cleared Aug 27, 1980
VIVALITH 5, - MDL-201A & TDL-201A
K801763 · DXY
Pacesetter Systems
Cardiovascular · 30d
Cleared Aug 27, 1980
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828 · DTL
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Aug 27, 1980
MEDI-TRACE DISP. FLUSHING DEV./MONITOR
K801829 · KRA
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Aug 27, 1980
MODEL 9300 ELECTROCARDIOVALIDATOR
K801830 · DSF
Del Mar Avionics
Cardiovascular · 26d
Cleared Aug 27, 1980
MODEL 9200 VIS-U-SCAN
K801832 · DSH
Del Mar Avionics
Cardiovascular · 26d
Cleared Aug 27, 1980
BIOMEGA #423-B BLOOD PRESSURE & PULSE CK
K801923 · DXN
Bio Mega Diagnostic, Inc.
Cardiovascular · 15d
Cleared Aug 20, 1980
SONACOLOR 6100
K801647 · DXY
Carolina Medical Electronics
Cardiovascular · 33d
Cleared Aug 20, 1980
NON-INVASIVE, BLOOD PRESSURE MONITOR
K801657 · DXN
Biochem International, Inc.
Cardiovascular · 30d
Cleared Aug 20, 1980
MMI/GAELTEC CATHETER TIP TRANSDUC
K801756 · DXO
Medical Measurements, Inc.
Cardiovascular · 23d
Cleared Aug 20, 1980
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · DRT
General Electric Co.
Cardiovascular · 23d
Cleared Aug 20, 1980
CORDIS FLOW DIRECTED BALLOON CATHETER
K801865 · DYG
Cordis Corp.
Cardiovascular · 15d
Cleared Aug 14, 1980
ELECTRONIC PACEMAKER WAVEFORM ANALYZER
K800696 · KRE
Instromedix, Inc.
Cardiovascular · 139d
Cleared Aug 14, 1980
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
K801450 · DXY
Intermedics, Inc.
Cardiovascular · 55d
Cleared Aug 13, 1980
IONESCU-SHILEY PERICARDIAL PATCH
K801764 · DXZ
Shiley, Inc.
Cardiovascular · 16d
Cleared Aug 07, 1980
ELECTROCARDIOGRAPH, MODEL ECG-5503
K801677 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 16d