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
9241–9264 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 24, 2000
TFX MEDICAL INTRODUCER ASSEMBLY
K993191 · DYB
Tfx Medical, Inc.
Cardiovascular · 183d
Cleared Mar 23, 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · DXT
Unimachs Corp.
Cardiovascular · 511d
Cleared Mar 23, 2000
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · DXC
Pilling Weck Surgical
Cardiovascular · 269d
Cleared Mar 23, 2000
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
K993292 · MJN
Boston Scientific, Target
Cardiovascular · 174d
Cleared Mar 23, 2000
SOLAR 7/8000
K993757 · DSI
General Electric Medical Systems...
Cardiovascular · 139d
Cleared Mar 23, 2000
NARKOMED 6000
K993826 · MLC
Draeger Medical, Inc.
Cardiovascular · 132d
Cleared Mar 23, 2000
EP MEDSYSTEMS, EP-WORKMATE
K994011 · DQK
Ep Medsystems, Inc.
Cardiovascular · 118d
Cleared Mar 21, 2000
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
K992703 · DQK
Premier Heart, LLC
Cardiovascular · 222d
Cleared Mar 20, 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
K000635 · MWI
Agilent Technologies, Inc.
Cardiovascular · 24d
Cleared Mar 15, 2000
IN-LINE HEMOSTASIS VALVE
K990975 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 358d
Cleared Mar 15, 2000
THE HOMMED SENTRY, MODEL 1 SENTRY
K993938 · DXN
Hommed, LLC
Cardiovascular · 117d
Cleared Mar 14, 2000
MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
K000675 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 15d
Cleared Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS...
K994157 · DSP
Datascope Corp.
Cardiovascular · 95d
Cleared Mar 08, 2000
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING,...
K992912 · DRF
Cardiac Pathways Corp.
Cardiovascular · 191d
Cleared Mar 08, 2000
LEMAITRE IRRIGATION CATHETER
K992933 · DXE
Vascutech, Inc.
Cardiovascular · 190d
Cleared Mar 07, 2000
ALLON 2000
K992386 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 235d
Cleared Mar 06, 2000
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
K992908 · DSI
Quinton, Inc.
Cardiovascular · 189d
Cleared Mar 01, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE
K000011 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared Mar 01, 2000
MPT 24 AND VITAL VIEW 24
K000276 · DRG
Criticare Systems, Inc.
Cardiovascular · 30d
Cleared Mar 01, 2000
ADVANTA SUPER SOFT GRAFT
K000499 · DSY
Atrium Medical Corp.
Cardiovascular · 15d
Cleared Mar 01, 2000
ADVANTA SUPER SOFT GRAFT
K000504 · DYF
Atrium Medical Corp.
Cardiovascular · 15d
Cleared Mar 01, 2000
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
K991684 · DWJ
Thermogear, Inc.
Cardiovascular · 289d
Cleared Mar 01, 2000
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES...
K992524 · DSA
Advantage Medical Electronics, Inc.
Cardiovascular · 217d
Cleared Mar 01, 2000
LEMAITRE VENOUS THROMBECTOMY CATHETER
K992934 · DXE
Vascutech, Inc.
Cardiovascular · 183d