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
6841–6864 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 24, 2006
SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL
K062140 · OCL
Cryocath Technologies, Inc.
Cardiovascular · 28d
Cleared Aug 24, 2006
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K061733 · DQO
AngioDynamics, Inc.
Cardiovascular · 65d
Cleared Aug 23, 2006
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90,...
K062145 · DYB
Acumen Medical, Inc.
Cardiovascular · 27d
Cleared Aug 22, 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K062134 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 27d
Cleared Aug 22, 2006
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302,...
K061959 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 42d
Cleared Aug 22, 2006
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
K061866 · JOW
Thermotek, Inc.
Cardiovascular · 50d
Cleared Aug 22, 2006
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
K061628 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 71d
Cleared Aug 22, 2006
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
K061369 · DWA
Cardiacassist, Inc.
Cardiovascular · 97d
Cleared Aug 22, 2006
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
K060911 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 141d
Cleared Aug 21, 2006
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K061480 · DQY
Medtronic, Ireland
Cardiovascular · 83d
Cleared Aug 18, 2006
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
K062168 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 18d
Cleared Aug 18, 2006
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67
K062084 · DQY
Acumen Medical, Inc.
Cardiovascular · 28d
Cleared Aug 18, 2006
LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K061279 · DXN
Little Doctor (Shanghai) Electronic
Cardiovascular · 102d
Cleared Aug 17, 2006
ZOLL R SERIES DEFIBRILLATOR
K060559 · MKJ
ZOLL Medical Corporation
Cardiovascular · 168d
Cleared Aug 16, 2006
DMS 300-7
K062007 · DSH
Diagnostic Monitoring Software
Cardiovascular · 30d
Cleared Aug 14, 2006
ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
K061760 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 53d
Cleared Aug 14, 2006
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE...
K061610 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 66d
Cleared Aug 14, 2006
REFSTAR EXTERNAL REFERENCE PATCH
K061468 · DRF
Biosense Webster, Inc.
Cardiovascular · 80d
Cleared Aug 14, 2006
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
K061463 · DRF
Biosense Webster, Inc.
Cardiovascular · 80d
Cleared Aug 11, 2006
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
K062220 · MJN
Possis Medical, Inc.
Cardiovascular · 9d
Cleared Aug 11, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K062201 · NFA
Ev3, Inc.
Cardiovascular · 10d
Cleared Aug 11, 2006
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
K061994 · MSX
Ge Healthcare
Cardiovascular · 28d
Cleared Aug 11, 2006
JOSTRA HLM TUBING SETS WITH SAFELINE COATING
K061832 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 43d
Cleared Aug 11, 2006
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
K061707 · MKJ
Philips Medical Systems
Cardiovascular · 56d