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
7057–7080 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 31, 2006
BIOSIGN
K053112 · MWI
Oxford Biosignals Limited
Cardiovascular · 88d
Cleared Jan 31, 2006
GALIX ECG PROFESSIONAL STATION
K051163 · DPS
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 271d
Cleared Jan 26, 2006
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K053630 · DWA
Levitronix, LLC
Cardiovascular · 28d
Cleared Jan 26, 2006
ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
K053021 · DTS
Estech, Inc.
Cardiovascular · 92d
Cleared Jan 24, 2006
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K053185 · DXN
Medwave, Inc.
Cardiovascular · 71d
Cleared Jan 20, 2006
STELLAR 404T
K060058 · MWI
Larsen & Toubro Limited
Cardiovascular · 11d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA...
K052975 · MSX
Ge Healthcare
Cardiovascular · 88d
Cleared Jan 20, 2006
LIFENET EXCHANGE SYSTEM
K052854 · MSX
Medtronic Emergency Response Systems,...
Cardiovascular · 101d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING...
K051400 · MHX
Ge Healthcare
Cardiovascular · 234d
Cleared Jan 19, 2006
MERIT IMPRESS DIAGNOSTIC CATHETER
K053171 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 66d
Cleared Jan 19, 2006
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · DRA
St Jude Medical
Cardiovascular · 122d
Cleared Jan 19, 2006
VASCON NEUROPATH GUIDING CATHETER
K052004 · DQY
Vascon, LLC
Cardiovascular · 178d
Cleared Jan 18, 2006
3160 MRI PATIENT MONITORING SYSTEM
K053462 · MWI
Invivo Corporation
Cardiovascular · 36d
Cleared Jan 18, 2006
CRITIVIEW
K051145 · DPW
Critisense , Ltd.
Cardiovascular · 259d
Cleared Jan 17, 2006
SUTURING WASHER
K052642 · MAB
First Call, Inc.
Cardiovascular · 113d
Cleared Jan 17, 2006
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
K052570 · DWF
Cardiacassist, Inc.
Cardiovascular · 120d
Cleared Jan 17, 2006
SUPER SHEATH INTRODUCER SHEATH
K052557 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 123d
Cleared Jan 13, 2006
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,...
K053460 · MCW
Fox Hollow Technologies
Cardiovascular · 31d
Cleared Jan 13, 2006
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND...
K053436 · OCL
Cryocath Technologies, Inc.
Cardiovascular · 35d
Cleared Jan 13, 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
K052976 · DQK
Ge Healthcare
Cardiovascular · 81d
Cleared Jan 13, 2006
CARDIOSOFT PC ECG, USB VERSION
K052295 · DPS
Cardiosoft, L.P.
Cardiovascular · 143d
Cleared Jan 11, 2006
SIMPLICI-T ANNULOPLASTY SYSTEM
K052970 · KRH
Medtronic Heart Valves
Cardiovascular · 79d
Cleared Jan 11, 2006
6248VAL ADJUSTABLE VALVE
K052459 · DTL
Medtronic Vascular
Cardiovascular · 126d
Cleared Jan 10, 2006
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS,...
K053522 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 22d