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
8473–8496 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 14, 2002
AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
K012796 · DXN
Amluck, Inc.
Cardiovascular · 205d
Cleared Mar 14, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020233 · DXZ
Chase Medical, Inc.
Cardiovascular · 50d
Cleared Mar 13, 2002
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
K012983 · DQO
Acist Medical Systems, Inc.
Cardiovascular · 189d
Cleared Mar 12, 2002
IN-TIME RETRIEVAL DEVICE
K014109 · MMX
Boston Scientific, Target
Cardiovascular · 88d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054 · DQO
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Mar 07, 2002
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
K014075 · DQX
Baylis Medical Co., Inc.
Cardiovascular · 86d
Cleared Mar 06, 2002
PRIME ECG SYSTEM
K012414 · DPS
Meridian Medical Technologies, Inc.
Cardiovascular · 219d
Cleared Mar 06, 2002
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X
K013473 · MCW
Xtrak Medical, Inc.
Cardiovascular · 139d
Cleared Mar 05, 2002
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K014204 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 74d
Cleared Mar 01, 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT...
K020340 · DQX
Guidant Corp.
Cardiovascular · 28d
Cleared Feb 28, 2002
MODEL 9210 DELIVERY CATHETER, MODEL 9210
K013963 · DQY
Medtronic Vascular
Cardiovascular · 87d
Cleared Feb 27, 2002
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC...
K013651 · DSY
Intervascular
Cardiovascular · 113d
Cleared Feb 27, 2002
PADPRO, MODEL 2603
K020288 · MKJ
Padpro, LLC
Cardiovascular · 30d
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132 · DXZ
Chase Medical, Inc.
Cardiovascular · 42d
Cleared Feb 26, 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · DTZ
Dideco S.P.A.
Cardiovascular · 22d
Cleared Feb 22, 2002
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
K020161 · DQY
Guidant Corp.
Cardiovascular · 36d
Cleared Feb 21, 2002
SPHYGMOCOR PX MODEL SCOR-PX
K012487 · DXN
Atcor Medical Pty, Ltd.
Cardiovascular · 203d
Cleared Feb 21, 2002
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K020018 · MSX
Cardiopulmonary Corp.
Cardiovascular · 49d
Cleared Feb 21, 2002
MODIFICATION TO DATACAPTOR
K020197 · MWI
Capsule Technologie
Cardiovascular · 30d
Cleared Feb 21, 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K020494 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 8d
Cleared Feb 19, 2002
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
K020277 · DRQ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Feb 15, 2002
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE...
K012472 · DXN
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Feb 15, 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 30d