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
8857–8880 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 04, 2001
SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL...
K010737 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 23d
Cleared Mar 30, 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE...
K002019 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 270d
Cleared Mar 29, 2001
PRESSURE TRAK, MODEL 222-B
K010622 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 27d
Cleared Mar 29, 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · DXN
A&D Engineering, Inc.
Cardiovascular · 9d
Cleared Mar 27, 2001
LOCALISA CARDIAC NAVIGATION SYSTEM
K002869 · DQK
Medtronic Surgical Navigation...
Cardiovascular · 195d
Cleared Mar 27, 2001
3M LITTMANN
K003723 · DQD
3M Company
Cardiovascular · 113d
Cleared Mar 27, 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · DSY
Impra, Inc.
Cardiovascular · 90d
Cleared Mar 26, 2001
FOGARTY VALVULOTOME, MODEL 700091
K001734 · MGZ
Edwards Lifesciences, LLC
Cardiovascular · 292d
Cleared Mar 23, 2001
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
K000977 · DTR
Olson Medical Sales, Inc.
Cardiovascular · 361d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · MJN
Cook, Inc.
Cardiovascular · 238d
Cleared Mar 22, 2001
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
K010497 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 29d
Cleared Mar 21, 2001
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
K002507 · DYB
Arrow Intl., Inc.
Cardiovascular · 218d
Cleared Mar 21, 2001
KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
K010686 · DXQ
Golden Horse Medical Equipment (Wuxi)...
Cardiovascular · 13d
Cleared Mar 20, 2001
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM
K010482 · JOP
Echocath, Inc.
Cardiovascular · 28d
Cleared Mar 20, 2001
WRISTWATCH BLOOD PRESSURE MONITOR A46
K010498 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 27d
Cleared Mar 20, 2001
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · DRQ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 15d
Cleared Mar 19, 2001
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K002665 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 206d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254 · DQO
Cook, Inc.
Cardiovascular · 234d
Cleared Mar 15, 2001
PANASONIC TELE-HOMECARE SYSTEM
K004050 · MWI
Matsushita Electric Industrial Co., Ltd.
Cardiovascular · 76d
Cleared Mar 15, 2001
GALIX GBI -3S-LP
K992706 · MLO
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 581d
Cleared Mar 09, 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 28d
Cleared Mar 09, 2001
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
K010505 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 16d
Cleared Mar 08, 2001
PVS 1300 NEURO GUIDE WIRE
K002907 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 171d
Cleared Mar 07, 2001
SUPERCROSS CATHETER
K001856 · DQY
Abbott Vascular, Inc.
Cardiovascular · 261d