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
4033–4056 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 26, 2014
PRESSURE CONNECTING TUBE
K131770 · DQO
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 254d
Cleared Feb 25, 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · DQY
Vascular Solutions, Inc.
Cardiovascular · 103d
Cleared Feb 25, 2014
MODIFIED HD GUIDE CATHETER
K133177 · DQY
Concentric Medical, Inc.
Cardiovascular · 131d
Cleared Feb 25, 2014
SE-601 SERIES ELECTROCARDIOGRAPH
K131503 · DPS
Edan Instruments, Inc.
Cardiovascular · 277d
Cleared Feb 21, 2014
MONITOR B40
K133576 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 93d
Cleared Feb 21, 2014
OMNI PATENT MONITORS
K132229 · MWI
Infinium Medical
Cardiovascular · 218d
Cleared Feb 20, 2014
CANTATA(R) 2.9 MICROCATHETER
K131772 · KRA
Cook, Inc.
Cardiovascular · 248d
Cleared Feb 20, 2014
ADVANCED PERFUSION SYSTEM 1
K131041 · DTQ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 311d
Cleared Feb 19, 2014
MEDOS HILITE INFANT OXYGENATOR
K140181 · DTZ
Medos Medizintechnik AG
Cardiovascular · 26d
Cleared Feb 18, 2014
MEDOS HILITE OXYGENATOR
K140177 · DTZ
Medos Medizintechnik AG
Cardiovascular · 25d
Cleared Feb 18, 2014
SARNS SOFT-FLOW AORTIC CANNULA
K132451 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 196d
Cleared Feb 18, 2014
A SERIES AND Q SERIES PATIENT MONITORS
K131898 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 238d
Cleared Feb 14, 2014
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
K134004 · DRG
Cellco Partnership D/B/A Verizon...
Cardiovascular · 49d
Cleared Feb 14, 2014
ANGIOJET ULTRA AVX THROMBECTOMY SET
K133629 · QEW
Possis Medical, Inc.
Cardiovascular · 80d
Cleared Feb 14, 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133450 · MWI
Airstrip Technologies, LP
Cardiovascular · 95d
Cleared Feb 14, 2014
XCATH
K133296 · DYB
Alseal
Cardiovascular · 112d
Cleared Feb 14, 2014
REVEAL LINQ INSERTABLE CARDIAC MONITOR
K132649 · MXD
Medtronic, Inc.
Cardiovascular · 172d
Cleared Feb 13, 2014
INTRODUCER SETS, MODEL ADELANTE RADIAL
K130633 · DYB
Oscor, Inc.
Cardiovascular · 339d
Cleared Feb 12, 2014
PHYSIOFLOW Q-LINK
K140102 · DSB
Vasocom, Inc.
Cardiovascular · 28d
Cleared Feb 12, 2014
15 FR. TANDEMHEART ARTERIAL CANNULA
K133293 · DWF
Cardiacassist, Inc.
Cardiovascular · 110d
Cleared Feb 12, 2014
VENA PRO
K133274 · JOW
Innovamed Health, LLC
Cardiovascular · 111d
Cleared Feb 12, 2014
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
K132720 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 166d
Cleared Feb 12, 2014
POWERHEART G5 AED
K122758 · MKJ
Cardiac Science Corporation
Cardiovascular · 520d
Cleared Feb 11, 2014
V8 TRANSLUMINAL BAV CATHETER
K133607 · OZT
Intervalve, Inc.
Cardiovascular · 78d