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
10537–10560 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 19, 1996
G.E. STERILE ANGIOGRAPHIC TRAY
K960139 · DWS
GE Medical Systems
Cardiovascular · 94d
Cleared Apr 19, 1996
RDI CARDIAC INSULATION PAD
K960312 · DWP
R D Intl.
Cardiovascular · 88d
Cleared Apr 18, 1996
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
K950688 · DRT
Safety Tek Corp.
Cardiovascular · 429d
Cleared Apr 17, 1996
USCI IDEAL PTCA KIT
K953522 · MAV
Ryder Intl. Corp.
Cardiovascular · 265d
Cleared Apr 15, 1996
PLATINUM SERIES EP DIAGNOSTIC CATHETERS
K953185 · DRF
Medtronic Cardiorhythm
Cardiovascular · 280d
Cleared Apr 15, 1996
G.E. STERILE CT BIOPSY TRAY
K960144 · DWS
GE Medical Systems
Cardiovascular · 90d
Cleared Apr 15, 1996
CARBOMEDICS VALVE TESTER
K960169 · DTJ
Carbomedics, Inc.
Cardiovascular · 90d
Cleared Apr 15, 1996
NOGA
K960542 · DRF
Biosense, Ltd.
Cardiovascular · 68d
Cleared Apr 12, 1996
BRAUN HEMOSTASIS INTRODUCERS
K960406 · DYB
B.Braun Medical, Inc.
Cardiovascular · 74d
Cleared Apr 11, 1996
LMI ARTERIAL EMBOLECTOMY CATHETER
K954760 · DXE
Lucas Medical, Inc.
Cardiovascular · 177d
Cleared Apr 09, 1996
0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING
K955135 · DQX
Biocompatibles , Ltd.
Cardiovascular · 152d
Cleared Apr 09, 1996
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143 · DWS
GE Medical Systems
Cardiovascular · 84d
Cleared Apr 09, 1996
CONMED EKG STRIPPER
K960264 · DRX
Conmedcorp
Cardiovascular · 82d
Cleared Apr 09, 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K960501 · LIT
Boston Scientific Corp
Cardiovascular · 67d
Cleared Apr 09, 1996
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
K960517 · LIT
C.R. Bard, Inc.
Cardiovascular · 64d
Cleared Apr 08, 1996
FIRST PICC INTRODUCER CATHETER
K954906 · DYB
Becton Dickinson Vascular Access, Inc.
Cardiovascular · 166d
Cleared Apr 08, 1996
ACCELERATED TRANSMISSION PROTOCOL
K955060 · DXH
Instromedix, Inc.
Cardiovascular · 158d
Cleared Apr 05, 1996
ACS ANCHOR EXCHANGE DEVICE
K955175 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 144d
Cleared Apr 04, 1996
CARDIO PERFECT ST 2001
K935732 · DSI
Cardio Control BV
Cardiovascular · 855d
Cleared Apr 04, 1996
CARDIOSOFT/CARDIOSYS
K951130 · LOS
Marquette Electronics, Inc.
Cardiovascular · 388d
Cleared Apr 02, 1996
NUMED ATRIOSEPTOSTOMY CATHETER
K960070 · DQO
NuMED, Inc.
Cardiovascular · 88d
Cleared Apr 02, 1996
1-4F INFINITI ANGIOGRAPHIC CATHETER
K960975 · DQO
Cordis Corp.
Cardiovascular · 22d
Cleared Mar 29, 1996
BREEZE DIGITAL INFLATION DEVICE
K953676 · MAV
Namic
Cardiovascular · 235d
Cleared Mar 29, 1996
SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
K960801 · DQO
North American Instrument Corp.
Cardiovascular · 31d