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
8305–8328 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 14, 2002
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
K013038 · DTZ
Polystan A/S
Cardiovascular · 338d
Cleared Aug 14, 2002
DASH 3000/4000 PATIENT MONITOR
K020290 · MHX
General Electric Medical Systems...
Cardiovascular · 198d
Cleared Aug 14, 2002
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
K020984 · MKJ
Access Cardiosystems, Inc.
Cardiovascular · 149d
Cleared Aug 14, 2002
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
K022242 · DSY
Intervascular
Cardiovascular · 34d
Cleared Aug 14, 2002
507EL VITAL SIGNS MONITOR
K022435 · DRT
Criticare Systems, Inc.
Cardiovascular · 20d
Cleared Aug 13, 2002
ELECTROPHYSIOLOGY CATHETER
K012708 · NLH
Alliance Medical Corp.
Cardiovascular · 364d
Cleared Aug 13, 2002
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · DXQ
Ge Medical Systems Information...
Cardiovascular · 15d
Cleared Aug 09, 2002
FLEXLINE CLAMP
K010727 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 515d
Cleared Aug 08, 2002
SHEATH ADAPTER, MODEL SA-09847
K021723 · DYB
Arrow Intl., Inc.
Cardiovascular · 76d
Cleared Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 72d
Cleared Aug 08, 2002
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K022107 · DRN
Cardiomedics, Inc.
Cardiovascular · 41d
Cleared Aug 06, 2002
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
K020897 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 140d
Cleared Aug 06, 2002
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
K022281 · DTN
Polystan A/S
Cardiovascular · 22d
Cleared Aug 02, 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
K021455 · DQY
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 01, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012687 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 352d
Cleared Jul 31, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012688 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 351d
Cleared Jul 29, 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K022174 · DWF
Cardeon Corp.
Cardiovascular · 26d
Cleared Jul 26, 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
XTD THROMBECTOMY CATHETER, XX CM
K021641 · QEW
Xtrak Medical, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
ELPH INJECTION SYSTEM
K022116 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 25d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376 · DSI
Datex-Ohmeda
Cardiovascular · 84d
Cleared Jul 24, 2002
ABP FOR WINDOWS
K021517 · DSK
Rozinn Electronics, Inc.
Cardiovascular · 75d
Cleared Jul 24, 2002
HEARTLINE RECEIVING STATION
K022073 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 28d
Cleared Jul 23, 2002
MICROPAQ, MODELS 402, 404
K021681 · DRT
Welch Allyn Protocol, Inc.
Cardiovascular · 62d