FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
6529–6552 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 31, 2007
MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
K071564 · DRG
Philips Medical Systems
Cardiovascular · 85d
Cleared Aug 31, 2007
INNOVASA STAT*SEAL TOPICAL HEMOSTAT
K071225 · DXC
Innovasa, Inc.
Cardiovascular · 121d
Cleared Aug 31, 2007
THE PORTABLE ANSISCOPE
K071168 · DPS
Dyansys, Inc.
Cardiovascular · 126d
Cleared Aug 31, 2007
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K070795 · DSK
Atcor Medical Pty, Ltd.
Cardiovascular · 162d
Cleared Aug 30, 2007
PORTABLE ECSCOPE
K072353 · DPS
Dyansys Corp
Cardiovascular · 8d
Cleared Aug 30, 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 21d
Cleared Aug 30, 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT...
K071427 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 99d
Cleared Aug 29, 2007
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 105d
Cleared Aug 29, 2007
VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
K070661 · DXC
Vitalcor, Inc.
Cardiovascular · 173d
Cleared Aug 27, 2007
LIFESYNC ADAPTER, MODEL LS-302
K071751 · DSA
Lifesync Corporation
Cardiovascular · 60d
Cleared Aug 24, 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071336 · QEZ
Possis Medical, Inc.
Cardiovascular · 105d
Cleared Aug 24, 2007
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
K071029 · DQX
Stereotaxis, Inc.
Cardiovascular · 135d
Cleared Aug 23, 2007
THROMCAT THROMBECTOMY CATHETER SYSTEM
K072195 · MCW
Kensey Nash Corp.
Cardiovascular · 16d
Cleared Aug 22, 2007
REFLEXION SPIRAL VARIABLE RADIUS CATHETER
K072012 · DRF
St Jude Medical
Cardiovascular · 30d
Cleared Aug 22, 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K071350 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 100d
Cleared Aug 17, 2007
M3 MONITOR
K072131 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 15d
Cleared Aug 17, 2007
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
K072060 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 21d
Cleared Aug 17, 2007
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
K070970 · DQY
Penumbra, Inc.
Cardiovascular · 133d
Cleared Aug 17, 2007
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
K070036 · NQG
Ascent Healthcare Solutions
Cardiovascular · 226d
Cleared Aug 17, 2007
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
K070034 · NQG
Ascent Healthcare Solutions
Cardiovascular · 226d
Cleared Aug 16, 2007
VENDYS MODEL 5000 B/BC
K060980 · DQK
Endothelix, Inc.
Cardiovascular · 493d
Cleared Aug 15, 2007
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
K071699 · KRD
Aga Medical Corp.
Cardiovascular · 55d
Cleared Aug 15, 2007
KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K070828 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 142d
Cleared Aug 15, 2007
KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K070826 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 142d