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
7945–7968 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 04, 2003
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
K023548 · DQY
Velocimed
Cardiovascular · 286d
Cleared Aug 01, 2003
CARDIODIRECT, MODELS 12M, 12I, 12S
K024283 · DPS
Reynolds Medical , Ltd.
Cardiovascular · 221d
Cleared Aug 01, 2003
DBT, DYNAMIC BUBBLE TRAP
K031323 · DTM
Convergenza AG
Cardiovascular · 98d
Cleared Aug 01, 2003
MEDRAD MANUAL SYRINGE LOADER
K031483 · DXT
Medrad, Inc.
Cardiovascular · 81d
Cleared Aug 01, 2003
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
K031561 · DQK
Ge Medical Systems Information...
Cardiovascular · 74d
Cleared Aug 01, 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 22d
Cleared Aug 01, 2003
IQ HYDROPHILIC GUIDE WIRE
K032183 · DQX
Boston Scientific Corp
Cardiovascular · 15d
Cleared Jul 31, 2003
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F...
K030671 · DQY
Medtronic Vascular
Cardiovascular · 150d
Cleared Jul 30, 2003
POWERHEART AED G3, MODEL 9300
K031987 · MKJ
Cardiac Science
Cardiovascular · 33d
Cleared Jul 29, 2003
REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE
K031550 · DQK
Vivometrics, Inc.
Cardiovascular · 74d
Cleared Jul 25, 2003
MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR
K030221 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 185d
Cleared Jul 25, 2003
ELI 200+ AUDICOR
K031182 · DPS
Mortara Instrument, Inc.
Cardiovascular · 101d
Cleared Jul 25, 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · DTK
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Jul 25, 2003
MC2X MULTI-STAGE VENOUS CANNULA
K031776 · DWF
Medtronic Perfusion Systems
Cardiovascular · 45d
Cleared Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
K031459 · DQY
Guidant Corp.
Cardiovascular · 76d
Cleared Jul 22, 2003
EKOS PERIPHERAL INFUSION SYSTEM
K030637 · QEY
Ekos Corp.
Cardiovascular · 144d
Cleared Jul 22, 2003
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
K031161 · DRF
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared Jul 22, 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103 · DSH
Philips Medical Systems
Cardiovascular · 14d
Cleared Jul 18, 2003
APEEL CS CATHETER DELIVERY SYSTEM
K031906 · DYB
St Jude Medical
Cardiovascular · 28d
Cleared Jul 17, 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
K031211 · DQY
Medtronic Vascular
Cardiovascular · 91d
Cleared Jul 17, 2003
GALT MEDICAL GUIDEWIRE
K031916 · DQX
Galt Medical Corp.
Cardiovascular · 27d
Cleared Jul 17, 2003
RADIUS 018 COUGAR WIRE
K032129 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 7d
Cleared Jul 16, 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
K031376 · MHX
Ge Medical Systems Information...
Cardiovascular · 76d
Cleared Jul 15, 2003
SAFETY INTRODUCER NEEDLE
K030135 · DYB
B.Braun Medical, Inc.
Cardiovascular · 182d