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
4321–4344 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577 · KRD
MicroVention, Inc.
Cardiovascular · 104d
Cleared Jun 15, 2013
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE...
K130414 · LIT
Trireme Medical, Inc.
Cardiovascular · 116d
Cleared Jun 14, 2013
PG-800A SERIES
K131569 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 15d
Cleared Jun 14, 2013
INTELLIVUE PATIENT MONITOR MX400
K130849 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 80d
Cleared Jun 13, 2013
GUIDEWIRE, PURSUER SERIES
K130104 · DQX
Oscor, Inc.
Cardiovascular · 149d
Cleared Jun 10, 2013
DISPOSABLE 330PSI EXTENSION LINES
K120892 · DXT
Coeur, Inc.
Cardiovascular · 444d
Cleared Jun 07, 2013
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K131300 · DYB
Access Scientific, LLC
Cardiovascular · 31d
Cleared Jun 07, 2013
PRELUDE SHEATH INTRODUCER
K130791 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 77d
Cleared Jun 06, 2013
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K131346 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 28d
Cleared Jun 06, 2013
VECTOR PTA BALLOON DILATATION CATHETER
K131329 · LIT
R4 Vascular, Inc.
Cardiovascular · 29d
Cleared Jun 06, 2013
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
K131103 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 48d
Cleared Jun 05, 2013
TEMPUS PRO PATIENT MONITOR
K130773 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 77d
Cleared Jun 05, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
K130382 · DXC
Boston Scientific Corporation
Cardiovascular · 111d
Cleared Jun 04, 2013
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
K130290 · DRG
Intel-Ge Care Innovations, LLC
Cardiovascular · 118d
Cleared Jun 04, 2013
ULTRACHECK CURVE BLOOD PRESSURE CUFFS
K122365 · OED
Statcorp Medical
Cardiovascular · 302d
Cleared Jun 03, 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K124046 · DYB
Medical Components, Inc.
Cardiovascular · 154d
Cleared May 31, 2013
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K130293 · LIT
Cook, Inc.
Cardiovascular · 114d
Cleared May 30, 2013
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 34d
Cleared May 29, 2013
ADROIT GUIDING CATHETER
K131225 · DQY
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 29d
Cleared May 29, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K131121 · DXN
Health & Life Co., Ltd.
Cardiovascular · 37d
Cleared May 29, 2013
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
K131045 · DQK
Cardiac Designs, LLC
Cardiovascular · 44d
Cleared May 29, 2013
740 SELECT
K130411 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 99d
Cleared May 29, 2013
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
K130288 · DSH
Cardiac Insight, Inc.
Cardiovascular · 113d
Cleared May 29, 2013
VASOSTAT HEMOSTASIS DEVICE
K123041 · DXC
Forge Medical, Inc.
Cardiovascular · 243d