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
9457–9480 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 30, 1999
HT, MODEL HT PB
K990142 · DTB
Sulzer Oscor, Inc.
Cardiovascular · 192d
Cleared Jul 28, 1999
VOYAGER QUAD CANNULA
K983270 · DWF
Cardiothoracic Systems, Inc.
Cardiovascular · 314d
Cleared Jul 28, 1999
MODIFICATION TO ZYMED HOLTER 2000
K992197 · MLO
Zymed Medical Instrumentation
Cardiovascular · 28d
Cleared Jul 27, 1999
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
K984627 · DQO
Arterial Vascular Engineering, Inc.
Cardiovascular · 209d
Cleared Jul 23, 1999
PVS 1400 GUIDEWIRE
K990823 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 133d
Cleared Jul 23, 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K992231 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 21d
Cleared Jul 22, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K...
K990476 · MHX
Hewlett-Packard GmbH
Cardiovascular · 156d
Cleared Jul 21, 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · DXT
Medrad, Inc.
Cardiovascular · 78d
Cleared Jul 21, 1999
SCIMED ANGIOGRAPHIC CATHETERS
K992142 · DQO
Scimed
Cardiovascular · 27d
Cleared Jul 21, 1999
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
K992328 · DXN
Meditec Co., Ltd.
Cardiovascular · 9d
Cleared Jul 20, 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · DXQ
Deroyal Industries, Inc.
Cardiovascular · 78d
Cleared Jul 19, 1999
MEDITRON STETHOSCOPE SYSTEM
K991367 · DQD
Meditron AS
Cardiovascular · 90d
Cleared Jul 15, 1999
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
K983940 · DYB
Adam Spence Corp.
Cardiovascular · 252d
Cleared Jul 15, 1999
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS...
K991001 · DRF
Ep Medsystems
Cardiovascular · 112d
Cleared Jul 14, 1999
SOLAR 9500 INFORMATION MONITOR
K990068 · MHX
General Electric Medical Systems...
Cardiovascular · 187d
Cleared Jul 09, 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 60d
Cleared Jul 08, 1999
ATLAS MONITOR
K984033 · DRT
Welch Allyn, Inc.
Cardiovascular · 238d
Cleared Jul 08, 1999
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
K991211 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 90d
Cleared Jul 02, 1999
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
K991170 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 86d
Cleared Jul 01, 1999
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169 · DTB
Biotronik, Inc.
Cardiovascular · 85d
Cleared Jun 29, 1999
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
K984586 · DTN
Fresenius Hemotechnology, Inc.
Cardiovascular · 187d
Cleared Jun 28, 1999
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL...
K990705 · DYB
Medamicus, Inc.
Cardiovascular · 116d
Cleared Jun 25, 1999
6F HYDROLYSER THROMBECTOMY CATHETER
K990771 · QEZ
Cordis Corp.
Cardiovascular · 108d
Cleared Jun 24, 1999
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K991775 · DXG
Mennen Medical, Inc.
Cardiovascular · 30d