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
4225–4248 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 29, 2013
CONCIERGE GUIDING CATHETER
K132409 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Aug 29, 2013
ENSITE VELOCITY SYSTEM
K130727 · DQK
St Jude Medical
Cardiovascular · 164d
Cleared Aug 28, 2013
CARESCAPE MONITOR B850
K131414 · MHX
GE Healthcare Finland Oy
Cardiovascular · 104d
Cleared Aug 28, 2013
CARESCAPE MONITOR B650
K131223 · MHX
GE Healthcare Finland Oy
Cardiovascular · 120d
Cleared Aug 28, 2013
COLIGN
K131124 · DTL
Jilin Coronado Medical , Ltd.
Cardiovascular · 128d
Cleared Aug 28, 2013
LIDCO CNAP MODULE
K131048 · DXG
Lidco, Ltd.
Cardiovascular · 135d
Cleared Aug 27, 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · JOW
Covidien
Cardiovascular · 28d
Cleared Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
K131978 · DQY
Biotronik, Inc.
Cardiovascular · 56d
Cleared Aug 23, 2013
PRE-FORMED GUIDEWIRES
K130798 · DQX
Lake Region Medical, Inc.
Cardiovascular · 154d
Cleared Aug 23, 2013
CARDIODAY
K130516 · DQK
Getemed Medizin- Und...
Cardiovascular · 177d
Cleared Aug 22, 2013
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
K131085 · PFA
Mespere Lifesciences, Inc.
Cardiovascular · 126d
Cleared Aug 22, 2013
PROGIGY SUPPORT CATHETER
K130714 · DQY
Radius Medical, LLC
Cardiovascular · 160d
Cleared Aug 21, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
K130454 · MKJ
Physio-Control, Inc.
Cardiovascular · 180d
Cleared Aug 19, 2013
AXERA 2 ACCESS SYSTEM
K132263 · DYB
Arstasis, Inc.
Cardiovascular · 28d
Cleared Aug 16, 2013
INTELLIVUE PATIENT MONITOR
K131829 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 57d
Cleared Aug 16, 2013
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K123830 · JOW
Dalian Labtek Science & Development...
Cardiovascular · 247d
Cleared Aug 15, 2013
CONTRAST CONSERVATION SYSTEM
K131478 · DXT
Osprey Medical, Inc.
Cardiovascular · 85d
Cleared Aug 15, 2013
AMECO SHEATH INTRODUCER
K131144 · DYB
Ameco Medical Industries
Cardiovascular · 114d
Cleared Aug 15, 2013
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
K131063 · DQY
St Jude Medical
Cardiovascular · 121d
Cleared Aug 15, 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · DYB
Medical Components, Inc.
Cardiovascular · 155d
Cleared Aug 14, 2013
LASSO NAV DUO LOOP CATHETER
K130602 · DRF
Biosense Webster, Inc.
Cardiovascular · 160d
Cleared Aug 14, 2013
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
K123882 · DXN
Ageless Health Industrial
Cardiovascular · 240d
Cleared Aug 13, 2013
HOPER PTCA BALLOON CATHETER
K123473 · LOX
Lepu Medical Technology (Beijing)...
Cardiovascular · 273d
Cleared Aug 12, 2013
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
K132197 · DQY
Pendracare International, B.V.
Cardiovascular · 27d