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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11353–11376 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 14, 1994
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 13, 1994
SCOLE 300 ECG RECORDER
K923664 · DSH
Scole Engineering Co.
Cardiovascular · 540d
Cleared Jan 11, 1994
ACS POWERGUIDE CORONARY GUIDING CATHETER
K934009 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 146d
Cleared Jan 10, 1994
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K934727 · DWS
Cardiac Pacemakers, Inc.
Cardiovascular · 101d
Cleared Jan 07, 1994
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
K934411 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 119d
Cleared Jan 06, 1994
CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF
K933235 · DWZ
Cordis Corp.
Cardiovascular · 232d
Cleared Jan 05, 1994
SCIMED MAVERICK
K934793 · LIT
Scimed Peripheral Interventions
Cardiovascular · 91d
Cleared Dec 29, 1993
NAMTAI
K935652 · DXN
Nam Tai Electronics (Canada) , Ltd.
Cardiovascular · 36d
Cleared Dec 27, 1993
PATIENT CABLE
K932704 · DSA
Sentry Medical Products, Inc.
Cardiovascular · 207d
Cleared Dec 27, 1993
AVOXIMETER
K932954 · DQK
A-Vox Systems, Inc.
Cardiovascular · 193d
Cleared Dec 27, 1993
CORDIS OPTA 5(TM), MODIFICATION
K933236 · LIT
Cordis Corp.
Cardiovascular · 207d
Cleared Dec 21, 1993
TYSHAK PERIPHERAL BALLOON DILATION CATHETER
K931009 · LIT
NuMED, Inc.
Cardiovascular · 305d
Cleared Dec 21, 1993
CARDIMA TRACKER(R) INFUSION CATHETER
K932800 · KRA
Cardima, Inc.
Cardiovascular · 195d
Cleared Dec 16, 1993
TRACFINDER II
K924108 · DRF
Ep Technologies, Inc.
Cardiovascular · 489d
Cleared Dec 16, 1993
STEEROCATH II
K924109 · DRF
Ep Technologies, Inc.
Cardiovascular · 489d
Cleared Dec 16, 1993
516YT DISPLAY DRIVER
K926219 · DXJ
Vidco, Inc.
Cardiovascular · 371d
Cleared Dec 16, 1993
XDCS-100
K932083 · DXT
Microwave Medical Systems, Inc.
Cardiovascular · 230d
Cleared Dec 16, 1993
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT...
K934602 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Dec 16, 1993
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674 · LDD
Physio-Control Corp.
Cardiovascular · 8d
Cleared Dec 15, 1993
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268 · DSP
Kontron Instruments, Inc.
Cardiovascular · 259d
Cleared Dec 15, 1993
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 197d
Cleared Dec 10, 1993
VALVE SIZER
K934951 · DTI
Carbomedics, Inc.
Cardiovascular · 53d
Cleared Dec 09, 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · LIT
Boston Scientific Corp
Cardiovascular · 105d
Cleared Dec 09, 1993
LOC GUIDE WIRE EXTENSION
K934339 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 93d