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
10153–10176 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 05, 1997
MEDILOG FD4
K970902 · DSH
Oxford Instruments Medical Systems
Cardiovascular · 55d
Cleared May 02, 1997
TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE
K963418 · DQD
Transmedica, Inc.
Cardiovascular · 245d
Cleared May 01, 1997
FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
K964187 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 192d
Cleared May 01, 1997
CHANNEL BALLOON CATHETER
K970379 · LIT
Boston Scientific Corp
Cardiovascular · 87d
Cleared Apr 29, 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · DXT
Medrad, Inc.
Cardiovascular · 161d
Cleared Apr 29, 1997
BK-A
K970204 · DTD
Biotronik, Inc.
Cardiovascular · 98d
Cleared Apr 25, 1997
SPACELABS MEDICAL ECG ANALYSIS SYSTEM
K962930 · DQK
Spacelabs Medical, Inc.
Cardiovascular · 270d
Cleared Apr 24, 1997
EVS
K963886 · DYB
Applied Medical Resources
Cardiovascular · 210d
Cleared Apr 24, 1997
VANTAGE PERIPHERAL DILATATION CATHETER
K965183 · LIT
Guidant Corp.
Cardiovascular · 121d
Cleared Apr 24, 1997
JUPITER PTA CATHETERS (VARIOUS)
K970299 · LIT
Cordis Corp.
Cardiovascular · 87d
Cleared Apr 24, 1997
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · DRE
Cordis Corp.
Cardiovascular · 80d
Cleared Apr 23, 1997
THERMAL REGULATION SYSTEM BLANKET
K964377 · DWJ
Gibeck, Inc.
Cardiovascular · 173d
Cleared Apr 23, 1997
CHASE RETROGRADE CARDIOPLEGIA CANNULA
K964393 · DWF
Chase Medical, Inc.
Cardiovascular · 170d
Cleared Apr 22, 1997
TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
K963731 · DWJ
Enthermics Medical Systems, Inc.
Cardiovascular · 217d
Cleared Apr 21, 1997
GSI CANNULA WITH INTRODUCER
K970201 · DYB
General Surgical Innovations
Cardiovascular · 90d
Cleared Apr 17, 1997
ALEXANDER BOX, BATTERY, RECHARGEABLE
K963305 · BWA
Alexander Mfg. Co.
Cardiovascular · 238d
Cleared Apr 16, 1997
CHASE AORTIC ARCH CANNULA
K964193 · DWF
Chase Medical, Inc.
Cardiovascular · 177d
Cleared Apr 16, 1997
CHASE CURVED LEFT HEART VENT CATHETER
K964194 · DWF
Chase Medical, Inc.
Cardiovascular · 177d
Cleared Apr 16, 1997
CHASE MULTIPLE PERFUSION SET
K964200 · DWF
Chase Medical, Inc.
Cardiovascular · 177d
Cleared Apr 16, 1997
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
K970099 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 93d
Cleared Apr 16, 1997
700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
K970719 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared Apr 15, 1997
CONTINUOUS FLUSH DEVICE
K962129 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 316d
Cleared Apr 15, 1997
STEALTHSHIELD
K970755 · DRX
Vital Connections, Inc.
Cardiovascular · 43d
Cleared Apr 15, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K971192 · DSY
Impra, Inc.
Cardiovascular · 15d