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
6169–6192 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 25, 2008
AUDICOR SENSOR, MODELS: 2.0, 3.0
K080602 · DRX
Inovise Medical, Inc.
Cardiovascular · 206d
Cleared Sep 24, 2008
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736 · DQO
Terumo Medical Corp.
Cardiovascular · 6d
Cleared Sep 24, 2008
HEART SYNC PEDIATRIC, MODEL PED-100
K081442 · LDD
Heart Sync, LLC
Cardiovascular · 125d
Cleared Sep 24, 2008
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
K081371 · MKJ
Leonhard Lang GmbH
Cardiovascular · 132d
Cleared Sep 18, 2008
GLIDESHEATH
K082644 · DYB
Terumo Medical Corp.
Cardiovascular · 7d
Cleared Sep 18, 2008
TANDEMHEART TRANSSEPTAL CANNULA- EF 72
K082425 · DWF
Cardiacassist, Inc.
Cardiovascular · 27d
Cleared Sep 18, 2008
ZOLL R SERIES
K081574 · LDD
ZOLL Medical Corporation
Cardiovascular · 105d
Cleared Sep 17, 2008
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
K082542 · DXQ
Cardicare Company, Ltd.
Cardiovascular · 14d
Cleared Sep 16, 2008
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · OCL
St Jude Medical
Cardiovascular · 36d
Cleared Sep 16, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K082023 · NLH
Ascent Healthcare Solutions
Cardiovascular · 62d
Cleared Sep 15, 2008
PTFE INTERLOCK PEELABLE INTRODUCERS
K081394 · DYB
Enpath Medical, Inc.
Cardiovascular · 119d
Cleared Sep 12, 2008
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
K082312 · DPS
Heartscape Technologies, Ltd.
Cardiovascular · 30d
Cleared Sep 12, 2008
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 204d
Cleared Sep 11, 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · DQK
St Jude Medical
Cardiovascular · 15d
Cleared Sep 11, 2008
VASCUTRAK 2, MODELS: V14 AND V18
K082343 · PNO
Ymed, Inc.
Cardiovascular · 27d
Cleared Sep 11, 2008
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K081523 · NTE
Abbott Vascular-Vascular Solutions
Cardiovascular · 101d
Cleared Sep 11, 2008
HLM TUBING SET WITH BIOLINE COATING
K080592 · DWE
Maquet Cardiopulmonary, AG
Cardiovascular · 192d
Cleared Sep 09, 2008
AUDICOR, HEMO AMBULATORY MONITOR
K073545 · MWJ
Inovise Medical, Inc.
Cardiovascular · 266d
Cleared Sep 08, 2008
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K080116 · DXG
Transonic Systems, Inc.
Cardiovascular · 236d
Cleared Sep 04, 2008
MICARDIA ANNULOPLASTY BAND DR
K070488 · KRH
Micardia Corporation
Cardiovascular · 562d
Cleared Sep 02, 2008
BT3/6, BT12
K082077 · DXH
Corscience GmbH & Co. KG
Cardiovascular · 41d
Cleared Aug 29, 2008
MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
K082186 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 28d
Cleared Aug 29, 2008
FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
K081891 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 58d
Cleared Aug 28, 2008
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K082356 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 10d