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
4945–4968 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 16, 2011
HEALTHTRACKER
K110770 · DXN
Wistron Corporation
Cardiovascular · 243d
Cleared Nov 10, 2011
VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
K112838 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 43d
Cleared Nov 10, 2011
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
K111487 · MLO
Norav Medical Corp.
Cardiovascular · 163d
Cleared Nov 10, 2011
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
K110463 · MWI
Norav Medical , Ltd.
Cardiovascular · 266d
Cleared Nov 10, 2011
MULTIFUNCTION KEITO
K103058 · DXN
Aguiflai Iberica S.L.
Cardiovascular · 392d
Cleared Nov 10, 2011
NEXGEN EXPANDABLE CATHETER
K102925 · DYB
Nexgen Medical Systems, Inc.
Cardiovascular · 402d
Cleared Nov 09, 2011
AXERA ACCESS SYSTEM
K113110 · DYB
Arstasis, Inc.
Cardiovascular · 20d
Cleared Nov 09, 2011
ENSITE VELOCITY SYSTEM V.3.0
K112688 · DQK
St Jude Medical
Cardiovascular · 55d
Cleared Nov 09, 2011
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
K112601 · MWJ
Intricon Datrix Corporation
Cardiovascular · 63d
Cleared Nov 09, 2011
RUBICON SUPPORT CATHETER
K112303 · DQY
Boston Scientific
Cardiovascular · 90d
Cleared Nov 09, 2011
PATIENT MONITOR
K112190 · MHX
Mediana Co., Ltd.
Cardiovascular · 103d
Cleared Nov 09, 2011
POWERPRESS UNIT
K110276 · JOW
Hanuri Distribution, Inc.
Cardiovascular · 282d
Cleared Nov 08, 2011
HI-TORQUE POWERTURN
K112957 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 35d
Cleared Nov 04, 2011
M VISUM ALERT ALARM MANAGEMENT SYSTEM
K112282 · MSX
Mvisum, Inc.
Cardiovascular · 87d
Cleared Nov 03, 2011
HI TORQUE CONNECT GUIDEWIRE
K112381 · DQX
Lake Region Medical
Cardiovascular · 78d
Cleared Nov 02, 2011
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K112962 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 28d
Cleared Nov 02, 2011
REFLEX BALLON GUIDE CATHETER
K112262 · DQY
Reverse Medical Corporation
Cardiovascular · 86d
Cleared Nov 02, 2011
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · MMX
Cook, Inc.
Cardiovascular · 96d
Cleared Nov 02, 2011
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI
K102378 · DPS
Vectracor, Inc.
Cardiovascular · 439d
Cleared Oct 28, 2011
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K111693 · MKJ
Philips Medical Systems
Cardiovascular · 134d
Cleared Oct 27, 2011
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART...
K112917 · DQY
Medtronic, Inc.
Cardiovascular · 24d
Cleared Oct 27, 2011
VSI GUIDEWIRE
K112631 · DQX
Vascular Solutions, Inc.
Cardiovascular · 48d
Cleared Oct 27, 2011
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K111723 · MCW
Ev3, Inc.
Cardiovascular · 129d
Cleared Oct 27, 2011
ZOLL RESCUENETLINK
K111296 · MSX
Zoll Medical Corporation, World Wide...
Cardiovascular · 171d