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
14929–14952 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 06, 1985
MEDTRONIC MODEL 5561
K852356 · DTD
Medtronic Vascular
Cardiovascular · 64d
Cleared Aug 06, 1985
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
K852435 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 57d
Cleared Aug 05, 1985
OCCLUSION & OCCLUSION-IRRIGATION
K844918 · DQT
Clincal Instruments Corp.
Cardiovascular · 229d
Cleared Aug 05, 1985
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
K850952 · DYG
C.R. Bard, Inc.
Cardiovascular · 151d
Cleared Aug 05, 1985
AJDJUSTABLE SUCTION CONTROL VALVE
K851406 · DWD
American Omni Medical, Inc.
Cardiovascular · 118d
Cleared Aug 05, 1985
SILENT GUARD CAT. NO. SG-30
K851465 · DTL
American Omni Medical, Inc.
Cardiovascular · 116d
Cleared Aug 05, 1985
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
K851854 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 101d
Cleared Aug 05, 1985
DEFI 2
K851931 · LDD
S & W Medico Teknik
Cardiovascular · 95d
Cleared Aug 01, 1985
CARIOLINE(ELECTROCARDIOGRAPH)
K852770 · DPS
Remco Italia S.P.A.
Cardiovascular · 34d
Cleared Jul 31, 1985
OMRON DIGITAL BP MONITOR HEM-400C
K851707 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 97d
Cleared Jul 30, 1985
POROCOAT SCHATZKER II ACETABULUM
K852193 · DXQ
Depuy, Inc.
Cardiovascular · 71d
Cleared Jul 30, 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Jul 29, 1985
SECHRIST VOLUME VENTILATOR MODIFICATION
K850740
Sechrist Industries, Inc.
Cardiovascular · 182d
Cleared Jul 29, 1985
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
K851003 · DTM
Gish Biomedical, Inc.
Cardiovascular · 139d
Cleared Jul 29, 1985
DOPLETTE 10
K851269 · JOP
Imex Medical Systems, Inc.
Cardiovascular · 187d
Cleared Jul 29, 1985
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA
K851616 · JOP
Ausonics Pty , Ltd.
Cardiovascular · 102d
Cleared Jul 29, 1985
MORTARA INSTRUMENT MODEL EL-1
K851702 · DSI
Mortara Instrument, Inc.
Cardiovascular · 96d
Cleared Jul 29, 1985
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
K852253 · DTD
Cordis Corp.
Cardiovascular · 66d
Cleared Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Jul 29, 1985
SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281
K852915 · DTB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM ART J. BIP PACING LEAD USING POLY #030-2821
K852918 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · DXQ
Howmedica Corp.
Cardiovascular · 17d