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
6961–6984 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 27, 2006
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
K053491 · DQY
Penumbra, Inc.
Cardiovascular · 133d
Cleared Apr 27, 2006
AMPLATZER NOODLEWIRE GUIDEWIRE
K053187 · DQX
Aga Medical Corp.
Cardiovascular · 163d
Cleared Apr 27, 2006
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1
K051419 · DWJ
Inditherm Medical
Cardiovascular · 330d
Cleared Apr 26, 2006
ECP HEALTH SYSTEM, MODEL 2005
K052611 · DRN
Ecp Health, Inc.
Cardiovascular · 216d
Cleared Apr 25, 2006
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
K060660 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 43d
Cleared Apr 25, 2006
THROMCAT THROMBECTOMY CATHETER SYSTEM
K060016 · MCW
Kensey Nash Corp.
Cardiovascular · 112d
Cleared Apr 25, 2006
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
K053263 · DSI
Cardionet, Inc.
Cardiovascular · 154d
Cleared Apr 25, 2006
PHYSIOGLOVE ES
K050674 · DPS
Commwell , Ltd.
Cardiovascular · 406d
Cleared Apr 24, 2006
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
K060865 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 25d
Cleared Apr 24, 2006
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
K060807 · DQY
Biotronik, Inc.
Cardiovascular · 31d
Cleared Apr 21, 2006
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
K060954 · DQK
St. Jude Medical, Inc.-Endocardial...
Cardiovascular · 14d
Cleared Apr 21, 2006
HL888SF
K060835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 25d
Cleared Apr 19, 2006
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
K060757 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 29d
Cleared Apr 19, 2006
VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
K060712 · MWI
Visual Telecommunications Network, Inc.
Cardiovascular · 34d
Cleared Apr 19, 2006
ATRIA 3100, ATRIA 6100
K060167 · DPS
Cardiac Science Corporation
Cardiovascular · 86d
Cleared Apr 19, 2006
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K053356 · DXJ
Ge Medical Systems Information...
Cardiovascular · 138d
Cleared Apr 12, 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
K060960 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Apr 12, 2006
SYMMETRY BALLOON DILATATION CATHETER
K060959 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Apr 12, 2006
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
K060729 · DXN
Health & Life Co., Ltd.
Cardiovascular · 26d
Cleared Apr 12, 2006
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
K060327 · DQY
Vascular Solutions, Inc.
Cardiovascular · 62d
Cleared Apr 12, 2006
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K060223 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 72d
Cleared Apr 12, 2006
INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
K060039 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 96d
Cleared Apr 12, 2006
PROACT WITH GEL OR PROACT 1
K052243 · JOW
Proact, Inc.
Cardiovascular · 238d
Cleared Apr 10, 2006
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190,...
K051984 · NFA
Boston Scientific Corp
Cardiovascular · 262d