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
7177–7200 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 14, 2005
PICONIBP OEM MODULE
K051366 · DXN
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 112d
Cleared Sep 14, 2005
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
K052454 · NTE
Abbott Vascular Devices
Cardiovascular · 8d
Cleared Sep 12, 2005
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W,...
K051565 · DXN
Proton Healthcare , Ltd.
Cardiovascular · 90d
Cleared Sep 12, 2005
ANGIODYNAMICS, INC., MICRO ACCESS KITS
K051655 · DQR
AngioDynamics, Inc.
Cardiovascular · 83d
Cleared Sep 12, 2005
CAPIOX AF125X ARTERIAL FILTER
K052205 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 31d
Cleared Sep 12, 2005
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
K052302 · MAL
Boston Scientific Corp
Cardiovascular · 19d
Cleared Sep 09, 2005
ALL PURPOSE CUFF, MODEL 222APC
K051904 · DXQ
Suntech Medical, Inc.
Cardiovascular · 58d
Cleared Sep 08, 2005
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
K051134 · MKJ
Philips Medical Systems
Cardiovascular · 128d
Cleared Sep 08, 2005
LEVITRONIX CENTRIMAG BACK-UP CONSOLE
K051209 · KFM
Levitronix, LLC
Cardiovascular · 120d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
K052153 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
K052154 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Sep 06, 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · DYB
Terumo Medical Corp.
Cardiovascular · 26d
Cleared Sep 06, 2005
VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
K052209 · DPW
Vascular Control Systems, Inc.
Cardiovascular · 22d
Cleared Sep 02, 2005
SEER MC
K042782 · MLO
Ge Medical Systems Information...
Cardiovascular · 331d
Cleared Sep 02, 2005
ACCU-LEAD
K050443 · DRX
Kentec Medical, Inc.
Cardiovascular · 192d
Cleared Sep 02, 2005
ANGIOSCULPT SCORING BALLOON CATHETER
K050629 · PNO
Angioscore, Inc.
Cardiovascular · 175d
Cleared Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
K050863 · DQO
Boston Scientific Corp
Cardiovascular · 150d
Cleared Sep 02, 2005
EDWARDS PERIPHERAL DILATION CATHETER
K052149 · DQY
Edwards Lifesciences, LLC
Cardiovascular · 25d
Cleared Sep 02, 2005
CLIRPATH TURBO EXCIMER LASER CATHETERS
K052296 · PDU
Spectranetics Corp.
Cardiovascular · 10d
Cleared Sep 01, 2005
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
K051515 · DYB
Acumen Medical, Inc.
Cardiovascular · 85d
Cleared Sep 01, 2005
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
K051838 · DQY
Concentric Medical, Inc.
Cardiovascular · 56d
Cleared Aug 31, 2005
REGENSIS PERICARDIAL PATCH
K051405 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 92d
Cleared Aug 29, 2005
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
K050558 · DTK
C.R. Bard, Inc.
Cardiovascular · 179d
Cleared Aug 26, 2005
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
K050399 · MWI
Invivo Research, Inc.
Cardiovascular · 191d