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
6937–6960 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 23, 2006
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
K061072 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 36d
Cleared May 19, 2006
ARGUS, MODEL LCM
K053207 · MHX
Schiller AG
Cardiovascular · 184d
Cleared May 18, 2006
ENPATH MEDICAL STEERABLE SHEATH
K061119 · DQY
Enpath Medical, Inc.
Cardiovascular · 27d
Cleared May 18, 2006
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS...
K061063 · MCW
Foxhollow Technologies, Inc.
Cardiovascular · 31d
Cleared May 18, 2006
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
K053193 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 184d
Cleared May 17, 2006
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
K052691 · JOW
Suretek Medical
Cardiovascular · 231d
Cleared May 15, 2006
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A...
K061185 · MHX
Ge Healthcare
Cardiovascular · 17d
Cleared May 15, 2006
MODIFICATION TO POWERHEART ECD
K060934 · MKJ
Cardiac Science Corporation
Cardiovascular · 40d
Cleared May 15, 2006
MODIFICATION TO: CARDIMA ABLATION SYSTEM
K060715 · OCL
Cardima, Inc.
Cardiovascular · 59d
Cleared May 15, 2006
MORTARA SURVEYOR TELEMETRY CENTRAL STATION
K060135 · MHX
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared May 12, 2006
IVENA VASCULAR PATCH
K060396 · DXZ
Atrium Medical Corp.
Cardiovascular · 86d
Cleared May 12, 2006
MICRUS COURIER MICROCATHETERS
K060116 · DQO
Micrus Endovascular Corporation
Cardiovascular · 115d
Cleared May 10, 2006
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
K061000 · DRE
Cook Vascular, Inc.
Cardiovascular · 29d
Cleared May 10, 2006
ESTECH AORTIC EASY FLOW CANNULA
K060101 · DWF
Endoscopic Technologies, Inc.
Cardiovascular · 118d
Cleared May 09, 2006
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER,...
K060925 · DXN
ACON Laboratories, Inc.
Cardiovascular · 35d
Cleared May 05, 2006
INTRODUCER ASSEMBLY WITH ROTATOR LOCK
K060519 · DYB
Teleflex Medical
Cardiovascular · 67d
Cleared May 05, 2006
HOMMED CENTRAL STATION, VERSION 3.5
K053453 · DXN
Honeywell Hommed, LLC
Cardiovascular · 144d
Cleared May 05, 2006
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
K051760 · DXX
Stereotaxis, Inc.
Cardiovascular · 310d
Cleared May 04, 2006
PM-9000 EXPRESS PATIENT MONITOR
K053234 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 167d
Cleared May 04, 2006
REPROCESSED BALOON INFLATION DEVICE
K053188 · NKU
Sterilmed, Inc.
Cardiovascular · 170d
Cleared May 04, 2006
HOT DOG PATIENT WARMING SYSTEM
K052392 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 246d
Cleared Apr 28, 2006
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K060904 · MCW
Rex Medical, L.P.
Cardiovascular · 25d
Cleared Apr 28, 2006
PRESEP OLIGON OXIMETRY CATHETERS
K060093 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 106d
Cleared Apr 28, 2006
MICRUS GUIDE WIRE, WATUSI 0.014
K053265 · DQX
Micrus Endovascular Corporation
Cardiovascular · 157d