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
6481–6504 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 23, 2007
NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
K072362 · DTZ
Novalung GmbH
Cardiovascular · 62d
Cleared Oct 23, 2007
EXPANDING VASCULAR SHEATH
K070865 · DYB
Applied Medical
Cardiovascular · 208d
Cleared Oct 18, 2007
PULSION PICCO-2, MODEL 8500
K072735 · DXG
Pulsion Medical Systems AG
Cardiovascular · 21d
Cleared Oct 18, 2007
MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
K072516 · MWI
Midmark Diagnostics Group
Cardiovascular · 41d
Cleared Oct 12, 2007
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K072225 · PNO
Angioscore, Inc.
Cardiovascular · 63d
Cleared Oct 12, 2007
CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP),...
K070212 · DQX
Ovalum , Ltd.
Cardiovascular · 263d
Cleared Oct 09, 2007
MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
K071384 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 145d
Cleared Oct 05, 2007
MICRUS COURIER ENZO MICROCATHETER 0.0190
K072526 · DQO
Micrus Endovascular Corporation
Cardiovascular · 28d
Cleared Oct 05, 2007
SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS...
K072233 · MKJ
Leonhard Lang GmbH
Cardiovascular · 56d
Cleared Oct 04, 2007
ENDOWAVE INFUSION SYSTEM
K072507 · QEY
Ekos Corp.
Cardiovascular · 28d
Cleared Oct 04, 2007
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
K070798 · DXT
Coeur, Inc.
Cardiovascular · 195d
Cleared Oct 04, 2007
RADIUS SNARE
K070502 · DQY
Radius Medical Technologies, Inc.
Cardiovascular · 225d
Cleared Oct 03, 2007
NOVATOME, MODEL: SU101-50
K072051 · DWZ
Scholten Surgical Instruments, Inc.
Cardiovascular · 69d
Cleared Oct 03, 2007
BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
K072008 · DRG
Braemar, Inc.
Cardiovascular · 72d
Cleared Oct 03, 2007
E3-80 PORTABLE ECG RECORDER & ANALYZER
K071085 · MWJ
Micro-Star International Co., Ltd.
Cardiovascular · 169d
Cleared Oct 01, 2007
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
K063035 · MXC
Transnoma Medical, Inc.
Cardiovascular · 367d
Cleared Sep 28, 2007
QXT EXTRACTION CATHETER
K071727 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 95d
Cleared Sep 27, 2007
OMNIWAVE ENDOVASCULAR SYSTEM
K071762 · QEY
Omnisonics Medical Technologies
Cardiovascular · 90d
Cleared Sep 26, 2007
ASAHI PTCA GUIDE WIRE, X-TREME
K072431 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 28d
Cleared Sep 26, 2007
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
K070156 · DSB
Cardiodynamics International Corp.
Cardiovascular · 252d
Cleared Sep 25, 2007
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
K071805 · DSI
Datascope Corp.
Cardiovascular · 85d
Cleared Sep 25, 2007
AVIAFIT PULSATING LEGBAND
K071744 · JOW
Flowmedic , Ltd.
Cardiovascular · 90d
Cleared Sep 25, 2007
MODIFICATION TO RADIUS SNARE
K071457 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 123d
Cleared Sep 21, 2007
MODIFICATION TO: UNITY NETWORK ID
K071982 · MWI
Ge Medical Systems Information...
Cardiovascular · 64d