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
3649–3672 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 25, 2015
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
K143073 · DTZ
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 20, 2015
EOPA 3D Arterial Cannula
K150422 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Mar 20, 2015
FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR
K141460 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 291d
Cleared Mar 20, 2015
SUMMED HIGH PRESSURE LINE
K140356 · DQO
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 401d
Cleared Mar 19, 2015
BioMonitor
K143503 · MXD
Biotronik, Inc.
Cardiovascular · 99d
Cleared Mar 19, 2015
IS4/DF4 Port Plug
K143463 · DTD
Oscor, Inc.
Cardiovascular · 105d
Cleared Mar 16, 2015
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
K150030 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 67d
Cleared Mar 12, 2015
CardiacLinx
K142352 · DSI
Ross Medical Technology, Inc.
Cardiovascular · 202d
Cleared Mar 11, 2015
Attain Hybrid Guide Wire
K143316 · DQX
Medtronic, Inc.
Cardiovascular · 112d
Cleared Mar 09, 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
K141981 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 231d
Cleared Mar 05, 2015
FOXTROT NC PTCA Balloon Catheter
K143160 · LOX
Shanghai MicroPort Medical (Group)...
Cardiovascular · 122d
Cleared Mar 05, 2015
QuantaFlo
K143094 · JOM
Semler Scientific, Inc.
Cardiovascular · 128d
Cleared Mar 05, 2015
MASTRO PLUS BALLOON IN-DEFLATION DEVICE
K140943 · MAV
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 325d
Cleared Mar 04, 2015
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
K150360 · DRE
Spectranetics, Inc.
Cardiovascular · 20d
Cleared Mar 04, 2015
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
K142983 · PNO
Angioscore, Inc.
Cardiovascular · 139d
Cleared Mar 04, 2015
T3 Software
K142732 · MWI
Etiometry, Inc.
Cardiovascular · 162d
Cleared Feb 27, 2015
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
K150201 · DQY
Spectranetics, Inc.
Cardiovascular · 29d
Cleared Feb 26, 2015
Vector PTA Balloon Dilatation Catheter
K143652 · LIT
Vector Corporation, LLC
Cardiovascular · 65d
Cleared Feb 20, 2015
Spring Coil Guidewire
K143135 · DQX
Neometrics, Inc.
Cardiovascular · 112d
Cleared Feb 20, 2015
ZywieAI Software Library
K142693 · DPS
Zywie, Inc.
Cardiovascular · 151d
Cleared Feb 18, 2015
Medtronic Model 5392 External Pulse Generator (EPG)
K150246 · DTE
Medtronic, Inc.
Cardiovascular · 16d
Cleared Feb 17, 2015
Master Caution Device MCD
K142476 · DXH
Healthwatch , Ltd.
Cardiovascular · 167d
Cleared Feb 13, 2015
DIGITAL ELECTROCARDIOGRAPH
K141946 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 211d
Cleared Feb 12, 2015
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
K134046 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 408d