FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15001–15024 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 18, 1985
COPAL DIGITAL SPHYGMOMAMOMETER UA-550
K844285 · DXN
Takeda Medical, Inc.
Cardiovascular · 164d
Cleared Apr 18, 1985
BLOOD-PRESSURE ECG TRANSMITTER
K844310 · DXN
Instromedix, Inc.
Cardiovascular · 163d
Cleared Apr 18, 1985
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000
K844396 · DSK
Associated Mills, Inc.
Cardiovascular · 156d
Cleared Apr 18, 1985
POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000
K844397 · DSK
Associated Mills, Inc.
Cardiovascular · 156d
Cleared Apr 18, 1985
LEPTOS PULSE GENERATOR
K844794 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS-M PULSE GENERATOR
K844795 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS - PULSE GENERATOR
K844812 · DXY
Biotronik Sales, Inc.
Cardiovascular · 128d
Cleared Apr 18, 1985
KALOS-04 PULSE GENERATOR
K844841 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
NEOS-LP PULSE GENERATOR
K844842 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
TELEMANOMETER
K850166 · DRG
R.J. Ash, Medical Monitoring, Inc.
Cardiovascular · 92d
Cleared Apr 18, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050
K850318 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 83d
Cleared Apr 18, 1985
DISPLAY MONITOR (VD-711RA-VD-712RA)
K850343 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 80d
Cleared Apr 18, 1985
NEONATAL MONITOR 309
K850407 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 73d
Cleared Apr 18, 1985
PATIENT MONITOR MODEL RM-300
K850794 · DTR
Honeywell, Inc.
Cardiovascular · 51d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050
K850315 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050
K850316 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050
K850317 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
K851091 · JOQ
Medtronic Vascular
Cardiovascular · 29d
Cleared Apr 11, 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 164d
Cleared Apr 11, 1985
CARDIOSTAT 1 ECG RECORDER
K844392 · DPS
Siemens Elema AB
Cardiovascular · 149d
Cleared Apr 11, 1985
IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH
K851296 · DTB
Telectronics, Inc.
Cardiovascular · 10d
Cleared Apr 10, 1985
DIAGNOSTIC ULTRASOUND 105 & 110
K842539 · JOP
Diagnostic Ultrasound Corp.
Cardiovascular · 286d
Cleared Apr 10, 1985
Q-DOP
K843058 · JOP
Quinton, Inc.
Cardiovascular · 250d
Cleared Apr 10, 1985
SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A
K844791 · DSI
Analogic Corp.
Cardiovascular · 121d