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
14137–14160 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 11, 1987
ERA-20
K853194 · DTE
Biotronik Sales, Inc.
Cardiovascular · 589d
Cleared Mar 11, 1987
TRACETS 2000/ELECTRODES
K863674 · DRX
Lectec Corp.
Cardiovascular · 173d
Cleared Mar 11, 1987
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · DPS
Hewlett-Packard Co.
Cardiovascular · 41d
Cleared Mar 10, 1987
CARDIOMAX-II
K861543 · DXG
Columbus Instruments Intl. Corp.
Cardiovascular · 320d
Cleared Mar 10, 1987
DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE
K864985 · DRO
Medac, Inc.
Cardiovascular · 78d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-8240A
K865030 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-834OA
K865032 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 06, 1987
V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540
K864507 · LDF
Spectramed, Inc.
Cardiovascular · 112d
Cleared Mar 06, 1987
OMNI-TRAK
K864889 · DSB
Invivo Research Labs, Inc.
Cardiovascular · 84d
Cleared Mar 03, 1987
SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER
K863342 · DWF
Angiomedics, Inc.
Cardiovascular · 187d
Cleared Mar 03, 1987
PLURIMUS CARDIAC EVALUATION SYSTEM
K864401 · DSI
Vivix Corp.
Cardiovascular · 117d
Cleared Mar 03, 1987
ETP 300 NON-INVASIVE EXTERNAL PACEMAKER
K864986 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE
K864987 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
K864988 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ETP 180A NON-INVASIVE EXTERNAL PACEMAKER
K864989 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ASPIRATING NEEDLE, CATALOG CODE #12006
K865079 · DWF
Dlp, Inc.
Cardiovascular · 64d
Cleared Mar 03, 1987
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
K870034 · DTB
Oscor Medical Corp.
Cardiovascular · 57d
Cleared Mar 03, 1987
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
K870323 · DTE
Pace Medical
Cardiovascular · 34d
Cleared Mar 03, 1987
DAIG PACEMAKER LEAD ADAPTOR
K870562 · DTD
Daig Corp.
Cardiovascular · 21d
Cleared Feb 20, 1987
MODIFIED LASERFLO BLOOD PERFUSION MONITOR
K864259 · DPW
Tsi, Inc.
Cardiovascular · 114d
Cleared Feb 20, 1987
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE
K864320 · DRQ
Cordis Corp.
Cardiovascular · 109d
Cleared Feb 20, 1987
MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)
K864580 · DPS
Mortara Instrument, Inc.
Cardiovascular · 92d
Cleared Feb 20, 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943 · DQO
NuMED, Inc.
Cardiovascular · 65d
Cleared Feb 20, 1987
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
K870073 · DTL
Clinical Connections, Inc.
Cardiovascular · 43d