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
9217–9240 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 10, 2000
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY...
K000854 · MHX
Agilent Technologies, Inc.
Cardiovascular · 25d
Cleared Apr 10, 2000
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
K991458 · DXN
Matsushita Electric Corp. of America
Cardiovascular · 350d
Cleared Apr 10, 2000
TRANSLUMINAL BALLOON DILATATION CATHETER
K993305 · LIT
Boston Scientific Corp
Cardiovascular · 189d
Cleared Apr 10, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
K993448 · DTB
Ela Medical, Inc.
Cardiovascular · 181d
Cleared Apr 10, 2000
CARDIO-CARD INTERPRETATION SYSTEM I
K993616 · LOS
Nasiff Assoc., Inc.
Cardiovascular · 167d
Cleared Apr 07, 2000
RENEGADE HI-FLO MICROCATHETER
K000177 · KRA
Boston Scientific Corp
Cardiovascular · 78d
Cleared Apr 07, 2000
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
K000746 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 30d
Cleared Apr 07, 2000
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
K993414 · DPS
Prucka Engineering, Inc.
Cardiovascular · 178d
Cleared Apr 06, 2000
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753 · DRF
Cordis Corp.
Cardiovascular · 29d
Cleared Apr 06, 2000
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
K000763 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 28d
Cleared Apr 06, 2000
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT...
K000822 · DSI
Agilent Technologies, GmbH
Cardiovascular · 23d
Cleared Apr 06, 2000
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
K991060 · DRF
Zcv ,Inc.
Cardiovascular · 373d
Cleared Apr 04, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
K000029 · DTB
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Mar 31, 2000
ENVOY AND VISTA BRITE TIP
K000715 · DQY
Cordis Corp.
Cardiovascular · 29d
Cleared Mar 29, 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Mar 29, 2000
ZUMA GUIDE CATHETERS
K000677 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Mar 28, 2000
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
K000013 · DXT
Acist Medical Systems
Cardiovascular · 85d
Cleared Mar 28, 2000
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR,...
K000660 · DRO
Medical Data Electronics
Cardiovascular · 29d
Cleared Mar 28, 2000
WESCO BLANKET
K981093 · DWJ
Wesco, Inc.
Cardiovascular · 733d
Cleared Mar 28, 2000
GAS FILTER
K993060 · JOD
Olson Medical Sales, Inc.
Cardiovascular · 197d
Cleared Mar 28, 2000
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K994423 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 90d
Cleared Mar 28, 2000
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
K994430 · MSX
General Electric Medical Systems...
Cardiovascular · 90d
Cleared Mar 27, 2000
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Mar 24, 2000
5F GUIDING CATHETER
K000598 · DQY
Guidant Corp.
Cardiovascular · 30d