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
4969–4992 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 27, 2011
SPIDERFX EMBOLIC PROTECTION DEVICE
K111010 · NTE
Ev3, Inc.
Cardiovascular · 199d
Cleared Oct 25, 2011
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 27d
Cleared Oct 24, 2011
PATIENT MONITOR
K112803 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 27d
Cleared Oct 24, 2011
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
K112497 · DTK
C.R. Bard, Inc.
Cardiovascular · 56d
Cleared Oct 24, 2011
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
K110569 · MLO
Inovise Medical, Inc.
Cardiovascular · 238d
Cleared Oct 21, 2011
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
K112292 · NLH
Stryker Sustainability Solutions
Cardiovascular · 72d
Cleared Oct 21, 2011
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
K111854 · DRG
St. Jude Medical Systems AB
Cardiovascular · 114d
Cleared Oct 21, 2011
PHYSIOGLOVE ES WITH ECG ANALYSIS
K103791 · DPS
Commwell , Ltd.
Cardiovascular · 298d
Cleared Oct 20, 2011
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100...
K112269 · DXN
OSTAR MEDITECH CORP.
Cardiovascular · 73d
Cleared Oct 20, 2011
DELTEX MEDICAL CARDIOQ EDM
K111542 · DPW
Deltex Medical Limited
Cardiovascular · 140d
Cleared Oct 20, 2011
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
K110315 · QEZ
Nexgen Medical Systems, Inc.
Cardiovascular · 260d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745 · DQX
Boston Scientific Corporation
Cardiovascular · 27d
Cleared Oct 18, 2011
ABDOMINAL TOURNIQUET SYSTEM
K112384 · DXC
Compression Works, LLC
Cardiovascular · 61d
Cleared Oct 18, 2011
CARDIA-CATH
K112323 · DXO
Millar Instruments, Inc.
Cardiovascular · 67d
Cleared Oct 17, 2011
8FR TURBO - TANDEM SYSTEM
K112032 · DQY
Spectranetics Corp.
Cardiovascular · 94d
Cleared Oct 14, 2011
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
K112771 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 21d
Cleared Oct 14, 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Oct 14, 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7...
K112086 · DXT
Medrad, Inc.
Cardiovascular · 85d
Cleared Oct 12, 2011
BANTAM CATHETER (280MM BALLOON LENGTHS)
K112335 · DQY
ClearStream Technologies , Ltd.
Cardiovascular · 61d
Cleared Oct 12, 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · DQK
Ge Healthcare
Cardiovascular · 166d
Cleared Oct 11, 2011
SURESIGNS VS2+ -SURESIGNS VSI
K112652 · DXN
Philips Medical Systems
Cardiovascular · 29d
Cleared Oct 11, 2011
ONSET ACCESS CATHETER SYSTEM
K112629 · DQY
Onset Medical Corporation
Cardiovascular · 32d
Cleared Oct 07, 2011
GLOBALCARDIO
K111320 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 150d
Cleared Oct 06, 2011
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
K112579 · DQY
Avinger, Inc.
Cardiovascular · 30d