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
8713–8736 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 20, 2001
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
K011339 · DSI
Spacelabs Burdick, Inc.
Cardiovascular · 110d
Cleared Aug 20, 2001
PROPAQ ENCORE MODELS 202, 204, 206
K012451 · DRT
Welch Allyn Protocol, Inc.
Cardiovascular · 19d
Cleared Aug 17, 2001
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · DXQ
Welch Allyn, Inc.
Cardiovascular · 16d
Cleared Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 16d
Cleared Aug 17, 2001
GSIBP BLOOD PRESSURE CUFF
K012553 · DXQ
Globalshop, Inc.
Cardiovascular · 9d
Cleared Aug 16, 2001
MODIFICATION TO ENVOY PATIENT MONITOR
K011784 · DSI
Mennen Medical , Ltd.
Cardiovascular · 69d
Cleared Aug 16, 2001
ABN ANEROID SPHYGMOMANOMETER
K012444 · DXQ
Pt. Sugih Instrumendo Abadi
Cardiovascular · 15d
Cleared Aug 15, 2001
3T L. V. CONTROL VALVE
K001245 · MJJ
3t Medical Systems, LLC
Cardiovascular · 484d
Cleared Aug 15, 2001
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 30d
Cleared Aug 14, 2001
CG-3250 MINIRECEIVER
K012187 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 33d
Cleared Aug 14, 2001
PACEART TX3 CARDIAC EVENT RECORDER
K012407 · DXH
Paceart, Inc.
Cardiovascular · 15d
Cleared Aug 14, 2001
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
K012454 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
K012458 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
K012459 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460 · LDF
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · DQX
Boston Scientific Corp
Cardiovascular · 55d
Cleared Aug 10, 2001
CHASE CARDIOVASCULAR PATCH
K012248 · DXZ
Chase Medical, Inc.
Cardiovascular · 24d
Cleared Aug 08, 2001
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
K012054 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 37d
Cleared Aug 02, 2001
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 76d
Cleared Aug 01, 2001
8100/8500 VITAL SIGNS MONITOR
K012059 · MWI
Criticare Systems, Inc.
Cardiovascular · 30d
Cleared Jul 31, 2001
ZOLL M SERIES IBP OPERATION
K011865 · DSK
Zoll Medical Corp
Cardiovascular · 47d
Cleared Jul 27, 2001
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
K012035 · DXN
Braun GmbH
Cardiovascular · 28d
Cleared Jul 26, 2001
VIKING OPTIMA GUIDING CATHETER
K012002 · DQY
Guidant Corp.
Cardiovascular · 29d