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
6913–6936 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 22, 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · DQX
Guidant Corp.
Cardiovascular · 28d
Cleared Jun 21, 2006
DEFIBRILLATOR CABLE TESTER, MODEL DT2200
K061606 · DRG
Medical Devices/Padpro, Inc.
Cardiovascular · 12d
Cleared Jun 21, 2006
SMDIE DEVICE INTERFACING SYSTEM
K061590 · MWI
Siemens Medical Solutions Health...
Cardiovascular · 13d
Cleared Jun 21, 2006
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
K061456 · DXN
A&D Engineering, Inc.
Cardiovascular · 27d
Cleared Jun 20, 2006
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
K061546 · DTM
Maquet Cardiopulmonary, AG
Cardiovascular · 15d
Cleared Jun 19, 2006
CARTO RMT EP NAVIGATION SYSTEM V8
K060047 · DRF
Biosense Webster, Inc.
Cardiovascular · 164d
Cleared Jun 19, 2006
ACUMEN SINGLE-LUMEN DELIVERY SHEATH
K053400 · DYB
Acumen Medical, Inc.
Cardiovascular · 195d
Cleared Jun 14, 2006
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
K061403 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 26d
Cleared Jun 09, 2006
SENTRY OTC MONITOR
K061088 · DRG
Honeywell Hommed, LLC
Cardiovascular · 52d
Cleared Jun 09, 2006
GENESIS OTC MONITOR
K061087 · DRG
Honeywell Hommed, LLC
Cardiovascular · 52d
Cleared Jun 09, 2006
AS101, BLOOD PRESSURE CUFF
K060871 · DXQ
Wenzhou Longwan Medical Instrument...
Cardiovascular · 71d
Cleared Jun 09, 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · DPS
Omron Healthcare, Inc.
Cardiovascular · 79d
Cleared Jun 09, 2006
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
K060686 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 86d
Cleared Jun 07, 2006
CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
K060820 · DXN
Suntech Medical, Inc.
Cardiovascular · 72d
Cleared Jun 07, 2006
BRIVANT GUIDEWIRE
K060551 · DQX
Brivant Limited
Cardiovascular · 97d
Cleared Jun 06, 2006
STOCKERT HEATER-COOLER SYSTEM 3T
K052601 · DWC
Sorin Group Deutschland GmbH
Cardiovascular · 258d
Cleared Jun 02, 2006
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
K061171 · DQX
Biosphere Medical, Inc.
Cardiovascular · 36d
Cleared Jun 02, 2006
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH...
K061031 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 49d
Cleared Jun 02, 2006
STOCKERT S5 SYSTEM
K060053 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 147d
Cleared May 30, 2006
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
K060449 · DQX
Guidant Corporation
Cardiovascular · 98d
Cleared May 26, 2006
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS...
K061052 · MHX
Philips Medical Systems North...
Cardiovascular · 39d
Cleared May 24, 2006
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 252d
Cleared May 23, 2006
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · KRH
Medtronic Vascular
Cardiovascular · 29d
Cleared May 23, 2006
DVTCARE CA5
K061125 · JOW
Doctors Orders
Cardiovascular · 29d