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
5401–5424 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 01, 2010
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH)...
K102176 · DRA
Medtronic Cryocath, LP
Cardiovascular · 29d
Cleared Sep 01, 2010
VITAL SIGNS MONITOR
K101602 · MLD
Criticare Systems, Inc.
Cardiovascular · 85d
Cleared Aug 31, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
K101950 · DXN
Andon Health Co, Ltd.
Cardiovascular · 50d
Cleared Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339 · DQX
Medtronic, Inc.
Cardiovascular · 111d
Cleared Aug 31, 2010
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
K100518 · DWP
Instrumed International, Inc.
Cardiovascular · 189d
Cleared Aug 30, 2010
BLOOD PRESSURE METER, MODEL CH-609
K100055 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 234d
Cleared Aug 30, 2010
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 385d
Cleared Aug 27, 2010
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
K102129 · DWA
Levitronix, LLC
Cardiovascular · 29d
Cleared Aug 27, 2010
HEINE GAMMA G7
K101892 · DXQ
Heine Optotechnik GmbH & Co. KG
Cardiovascular · 51d
Cleared Aug 27, 2010
MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
K101702 · JOW
Midwest Reprocessing Center, LLC
Cardiovascular · 71d
Cleared Aug 27, 2010
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS,...
K101330 · JOW
Midwest Reprocessing Center, LLC
Cardiovascular · 107d
Cleared Aug 27, 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP...
K100763 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 163d
Cleared Aug 25, 2010
DUFLO CATHETER (HEPARIN COATED)
K093847 · MJN
Thermopeutix, Inc.
Cardiovascular · 252d
Cleared Aug 19, 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K101789 · NLH
Sterilmed, Inc.
Cardiovascular · 52d
Cleared Aug 13, 2010
INQUIRY AFOCUSII DIAGNOSTIC CATHETER
K101623 · DRF
St Jude Medical
Cardiovascular · 65d
Cleared Aug 13, 2010
PICC WAND PEELABLE SAFETY INTRODUCER
K101150 · DYB
Access Scientific, Inc.
Cardiovascular · 112d
Cleared Aug 11, 2010
COMBAT READY CLAMP
K102025 · DXC
Combat Medical Systems, LLC
Cardiovascular · 23d
Cleared Aug 11, 2010
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
K101660 · DSA
Kepler Medtec
Cardiovascular · 58d
Cleared Aug 11, 2010
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K101479 · DQY
Reflow Medical
Cardiovascular · 75d
Cleared Aug 11, 2010
OMNI III PATIENT MONITOR
K101052 · MWI
Infinium Medical
Cardiovascular · 118d
Cleared Aug 07, 2010
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · KRH
Medtronic, Inc.
Cardiovascular · 99d
Cleared Aug 06, 2010
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
K102022 · DQY
Avinger, Inc.
Cardiovascular · 18d
Cleared Aug 06, 2010
VASOPRESS SUPREME MINI MODEL VP500DM
K101915 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 28d
Cleared Aug 06, 2010
OCCLUSION BALLOON CATHETER MODEL OBC
K101877 · DQY
Cook, Inc.
Cardiovascular · 31d