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
5569–5592 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 14, 2010
INTELLIVUE CLINICAL INFORMATION PORTFOLIO
K100272 · DXJ
Philips Medical Systems
Cardiovascular · 75d
Cleared Apr 14, 2010
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
K093907 · DXN
Welch Allyn, Inc.
Cardiovascular · 113d
Cleared Apr 13, 2010
RETROFLEX DILATOR KIT
K093554 · DRE
Edwards Lifesciences, LLC
Cardiovascular · 147d
Cleared Apr 12, 2010
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · KRA
Boston Scientific Corp
Cardiovascular · 12d
Cleared Apr 09, 2010
ULTRAVIEW DM3 MONITOR
K093802 · DXN
Zoe Medical, Inc.
Cardiovascular · 119d
Cleared Apr 08, 2010
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
K100046 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 90d
Cleared Apr 08, 2010
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
K093288 · QYX
Cardionet, Inc.
Cardiovascular · 170d
Cleared Apr 02, 2010
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
K093858 · DSA
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 107d
Cleared Apr 02, 2010
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS...
K092785 · DSH
Vasomedical, Inc.
Cardiovascular · 204d
Cleared Apr 01, 2010
SE-601 SERIES ELECTROCARDIOGRAPH
K093869 · DPS
Edan Instruments, Inc.
Cardiovascular · 105d
Cleared Apr 01, 2010
PADCHECK
K093205 · DXN
Padtest, LLC
Cardiovascular · 170d
Cleared Apr 01, 2010
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
K092391 · MKJ
Concord Medical Products
Cardiovascular · 239d
Cleared Mar 31, 2010
HANDHELD ECG MONITOR, MODEL MD100
K093872 · DPS
Beijing Choice Electronic Technololgy...
Cardiovascular · 104d
Cleared Mar 30, 2010
ARSTASIS ACCESS SYSTEM
K100615 · DYB
Arstasis, Inc.
Cardiovascular · 26d
Cleared Mar 26, 2010
TORQMAX SHEATH GRIP ACCESSORY
K093257 · OFC
Spectranetics Corp.
Cardiovascular · 158d
Cleared Mar 26, 2010
FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217
K092061 · DXN
Genexel Medical Instrument, Inc.
Cardiovascular · 261d
Cleared Mar 25, 2010
RAISIN PERSONAL MONITOR
K093976 · DXH
Proteus Biomedical, Inc.
Cardiovascular · 91d
Cleared Mar 25, 2010
FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT
K093831 · DXN
Health & Life Co., Ltd.
Cardiovascular · 101d
Cleared Mar 24, 2010
XRES BLOOD COLLECTION RESERVOIR
K100507 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Mar 23, 2010
SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
K094044 · DSY
Tayside Flow Technologies Limited
Cardiovascular · 82d
Cleared Mar 23, 2010
EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE
K090364 · LIT
Angioslide, Ltd.
Cardiovascular · 403d
Cleared Mar 22, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY,...
K100303 · PNO
Angioscore, Inc.
Cardiovascular · 47d
Cleared Mar 22, 2010
GORE DRYSEAL SHEATH
K093791 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 102d
Cleared Mar 17, 2010
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS
K093965 · LIT
C.R. Bard, Inc.
Cardiovascular · 84d