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
5665–5688 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905,...
K092510 · DXN
Andon Health Co, Ltd.
Cardiovascular · 128d
Cleared Dec 23, 2009
ZOLL E SERIES WITH CPRREADYCHARGE
K091265 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 237d
Cleared Dec 23, 2009
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
K090690 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 282d
Cleared Dec 23, 2009
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
K090555 · DTR
Maquet Cardiopulmonary, AG
Cardiovascular · 296d
Cleared Dec 23, 2009
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
K090534 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 299d
Cleared Dec 18, 2009
AF 840 PH.I.S.I.O. ARTERIAL FILTER
K093601 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Dec 18, 2009
INTELLIBRIDGE SYSTEM
K093177 · MWI
Philips Medical Systems
Cardiovascular · 71d
Cleared Dec 18, 2009
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
K093050 · DQY
Arrow Intl., Inc.
Cardiovascular · 79d
Cleared Dec 18, 2009
HLM TUBING SET WITH SOFTLINE COATING
K090533 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 294d
Cleared Dec 18, 2009
QUART ARTERIAL FILTER WITH SOFTLINE COATING
K090518 · DTM
Maquet Cardiopulmonary, AG
Cardiovascular · 295d
Cleared Dec 18, 2009
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 295d
Cleared Dec 17, 2009
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
K093397 · DQX
MicroVention, Inc.
Cardiovascular · 48d
Cleared Dec 17, 2009
HEALTHEPOD
K083174 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 416d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
St Jude Medical
Cardiovascular · 26d
Cleared Dec 15, 2009
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
K090785 · MWI
Invivo Corp.
Cardiovascular · 267d
Cleared Dec 14, 2009
ELI 350 ELECTROCARDIOGRAPH
K092663 · DPS
Mortara Instrument, Inc.
Cardiovascular · 105d
Cleared Dec 10, 2009
HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
K092807 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 90d
Cleared Dec 10, 2009
NEONATAL ECG ELECTRODE, M203KEN
K092744 · DRX
R & D Medical Products, Inc.
Cardiovascular · 93d
Cleared Dec 10, 2009
TERUMO PRESSURE ISOLATOR
K092644 · DRS
Terumo Cardiovascular Systems Corp.
Cardiovascular · 105d
Cleared Dec 09, 2009
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER...
K093750 · KRA
Ev3, Inc.
Cardiovascular · 2d
Cleared Dec 08, 2009
CROSSCATH SUPPORT CATHTER
K093052 · KRA
Cook, Inc.
Cardiovascular · 69d
Cleared Dec 07, 2009
QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR
K093522 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 24d
Cleared Dec 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
K093528 · DXN
Andon Health Co, Ltd.
Cardiovascular · 18d
Cleared Dec 04, 2009
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
K093455 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d