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
5353–5376 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 22, 2010
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
K103095 · LOX
Medtronic, Ireland
Cardiovascular · 14d
Cleared Oct 22, 2010
SENSEI X ROBOTIC CATHETER SYSTEM
K102168 · DXX
Hansen Medical, Inc.
Cardiovascular · 81d
Cleared Oct 22, 2010
KANEKA PHARMA AMERICA XPRESS-WAY RX
K101839 · QEZ
Kaneka Pharma America, LLC
Cardiovascular · 113d
Cleared Oct 21, 2010
INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40,...
K102562 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 44d
Cleared Oct 20, 2010
CARESCAPE MODEL V100 VITAL SIGNS MONITOR
K102426 · MWI
Ge Medical Systems Information...
Cardiovascular · 56d
Cleared Oct 20, 2010
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K101497 · DYB
Oscor, Inc.
Cardiovascular · 141d
Cleared Oct 19, 2010
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K102737 · JOW
Covidien, LLC
Cardiovascular · 27d
Cleared Oct 19, 2010
VASOGRAD DVT COMPRESSION GARMENT
K102732 · JOW
Compression Therapy Concepts
Cardiovascular · 27d
Cleared Oct 19, 2010
UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX
K093244 · DWJ
Geratherm Medical AG
Cardiovascular · 369d
Cleared Oct 19, 2010
HRV ACQUIRE
K092809 · DRT
Wr Medical Electronics Co.
Cardiovascular · 403d
Cleared Oct 18, 2010
LIVEWIRE ELECTOPHYSIOLOGY CATHETER
K102721 · DRF
St Jude Medical
Cardiovascular · 27d
Cleared Oct 18, 2010
CARESCAPE MONITOR B650
K102239 · MHX
GE Healthcare Finland Oy
Cardiovascular · 70d
Cleared Oct 15, 2010
ELECTRONIC BLOOD PRESSURE MONITOR
K102920 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 14d
Cleared Oct 15, 2010
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY...
K101955 · DRF
St Jude Medical
Cardiovascular · 95d
Cleared Oct 13, 2010
COMPASS VASCULAR ACCESS
K101518 · DRS
Mirador Biomedical, Inc.
Cardiovascular · 133d
Cleared Oct 13, 2010
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
K100310 · MWJ
BTL Industries, Inc.
Cardiovascular · 252d
Cleared Oct 12, 2010
EMCOOLSPAD
K100071 · NZE
Emcools Emergency Medical Cooling...
Cardiovascular · 274d
Cleared Oct 08, 2010
LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
K101331 · DQK
C.R. Bard Inc., Bard...
Cardiovascular · 150d
Cleared Oct 07, 2010
ARSTASIS ACCESS SYSTEM
K102728 · DYB
Arstasis, Inc.
Cardiovascular · 15d
Cleared Oct 07, 2010
ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
K102582 · JOW
Devon Medical, Inc.
Cardiovascular · 29d
Cleared Oct 05, 2010
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K102596 · DSY
Atrium Medical Corp.
Cardiovascular · 26d
Cleared Oct 01, 2010
WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
K101148 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 161d
Cleared Sep 30, 2010
M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
K102495 · MHX
Philips Medical Systems
Cardiovascular · 30d
Cleared Sep 30, 2010
ZOLL PROPAQ MD
K102468 · LDD
Zoll Medical Corporation, World Wide...
Cardiovascular · 31d