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
16561–16584 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 16, 1981
FOGARTY FLEXIBLE PROBE
K812935 · DWP
American Edwards Laboratories
Cardiovascular · 27d
Cleared Nov 16, 1981
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.
K812944 · DRF
Millar Instruments, Inc.
Cardiovascular · 27d
Cleared Nov 16, 1981
INTRODUCER, PERCUTANEOUS SELDINGER
K812964 · DYB
Triad Medical Division
Cardiovascular · 25d
Cleared Nov 16, 1981
PERCUTANEOUS INTRODUCER COURNAND STYLE
K812973 · DYB
Dip, Inc.
Cardiovascular · 24d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD
K812990 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD
K812991 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
PET POLYETHYLENE TORQUE CATHETER
K812999 · DQO
Universal Medical Instrument Corp.
Cardiovascular · 21d
Cleared Nov 16, 1981
PERCUTANEOUS INTRODUCER: SELDINGER STYLE
K813019 · DYB
Dip, Inc.
Cardiovascular · 20d
Cleared Nov 16, 1981
DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM
K813053 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 18d
Cleared Nov 06, 1981
TRONZO HIP
K812946 · DXQ
Biomet, Inc.
Cardiovascular · 17d
Cleared Nov 05, 1981
MODEL 325C UNIPOLAR CARDIAC PULSE GEN.
K812832 · DXY
Cook Pacemaker Corp.
Cardiovascular · 27d
Cleared Nov 02, 1981
SPHYGMOMANOMETER
K812409 · DXN
Somatronix Research Corp.
Cardiovascular · 73d
Cleared Nov 02, 1981
SHILEY ARTERIAL FILTER W/40 MICRON SCREE
K812742 · DTM
Shiley, Inc.
Cardiovascular · 34d
Cleared Nov 02, 1981
SORENSON THERMODILUTION CARDIAC COMPUT
K812757 · DXG
Sorensen Research
Cardiovascular · 33d
Cleared Nov 02, 1981
FLOW-DIRECTED BALLOON THERMODILUTION
K812761 · KRG
Nova Medical Specialties
Cardiovascular · 32d
Cleared Nov 02, 1981
THE NEW 1600 ELECTRODE
K812878 · DRX
Andover Medical, Inc.
Cardiovascular · 19d
Cleared Nov 02, 1981
TELECARE ISOTEC PRESSURE TRANSDUCER DOME
K812883 · DRS
Narco Scientific
Cardiovascular · 19d
Cleared Nov 02, 1981
NARCO TELECARE PRESSURE TRANSDUCER DOME
K812884 · DRS
Narco Scientific
Cardiovascular · 19d
Cleared Oct 29, 1981
MODEL 325T PROGRAMMABLE PULSE GENERATOR
K812358 · DXY
Cook Pacemaker Corp.
Cardiovascular · 70d
Cleared Oct 29, 1981
ADAPTAID #365-38
K812756 · DTD
Intermedics, Inc.
Cardiovascular · 29d
Cleared Oct 29, 1981
TEMPORARY PERVENOUS J-ATRIAL LEAD
K812781 · LDF
Cordis Corp.
Cardiovascular · 24d
Cleared Oct 29, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K812790 · DXY
Telectronics, Inc.
Cardiovascular · 24d
Cleared Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815 · DTB
Pacesetter Systems
Cardiovascular · 22d