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
7225–7248 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 04, 2005
INNER-LOCK INTRODUCER SHEATH
K051468 · DYB
Rex Medical
Cardiovascular · 62d
Cleared Aug 04, 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · DYB
Terumo Medical Corp.
Cardiovascular · 49d
Cleared Jul 28, 2005
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
K050808 · LYK
Cardio-Optics, Inc.
Cardiovascular · 120d
Cleared Jul 28, 2005
BIB PTA BALLOON CATHETER
K050857 · NVM
NuMED, Inc.
Cardiovascular · 114d
Cleared Jul 28, 2005
MINI GHOST PTA CATHETER, MODEL 507
K051343 · DQY
NuMED, Inc.
Cardiovascular · 66d
Cleared Jul 28, 2005
VITAL SIGNS MONITOR
K051375 · DXN
Mediana Co., Ltd.
Cardiovascular · 63d
Cleared Jul 25, 2005
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · DQD
3M Company
Cardiovascular · 24d
Cleared Jul 20, 2005
INFINITY MONITORS WITH SCIO MODIFICATIONS
K051628 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jul 19, 2005
MEDSTAR 220, MODEL 533-220
K050951 · DXH
Cibernet Systems Corp.
Cardiovascular · 95d
Cleared Jul 19, 2005
MARS HOLTER ANALYSIS WORKSTATION
K051026 · DQK
Ge Medical Systems Information...
Cardiovascular · 88d
Cleared Jul 19, 2005
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
K051634 · MSX
Ge Healthcare
Cardiovascular · 29d
Cleared Jul 15, 2005
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST
K051062 · DQX
Flowcardia, Inc.
Cardiovascular · 80d
Cleared Jul 14, 2005
READMYHEART, MODEL RMH3.0
K050620 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 126d
Cleared Jul 14, 2005
ILAB ULTRASOUND IMAGING SYSTEM
K051679 · OBJ
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jul 14, 2005
CARDIOMEM CM 3000-12
K051686 · MWJ
Getemed Medizin- Und...
Cardiovascular · 21d
Cleared Jul 08, 2005
UNITY NETWORK ID
K051518 · MWI
Ge Medical Systems Information...
Cardiovascular · 30d
Cleared Jul 01, 2005
PMP4 MEDICAL WEB CENTER
K050940 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 78d
Cleared Jul 01, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE...
K051106 · DXN
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 60d
Cleared Jun 29, 2005
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
K050858 · DPS
Heartlab, Inc.
Cardiovascular · 85d
Cleared Jun 29, 2005
CARDIODAY
K051471 · DQK
Getemed Medizin- Und...
Cardiovascular · 26d
Cleared Jun 29, 2005
STAR 50 MONITORING SYSTEM
K051608 · MWI
Larsen & Toubro Limited
Cardiovascular · 12d
Cleared Jun 24, 2005
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
K050877 · DRF
Biosense Webster, Inc.
Cardiovascular · 79d
Cleared Jun 24, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K051395 · DQO
Vascular Solutions, Inc.
Cardiovascular · 28d
Cleared Jun 24, 2005
ZOLL M SERIES 12SL ANALYSIS OPTION
K051475 · MKJ
ZOLL Medical Corporation
Cardiovascular · 21d