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
5161–5184 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 19, 2011
EVERON CENTRAL DISPLAY STATION (CDS)
K110521 · MSX
Earlysense, Ltd.
Cardiovascular · 55d
Cleared Apr 19, 2011
WEXLER VASCULAR CLAMP SERIES
K110148 · DXC
Microsurgical Laboratories,Inc.Dba...
Cardiovascular · 91d
Cleared Apr 15, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K110767 · PNO
Angioscore, Inc.
Cardiovascular · 28d
Cleared Apr 15, 2011
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
K102418 · DQY
Reverse Medical Corporation
Cardiovascular · 233d
Cleared Apr 14, 2011
EVERCROSS 0.035 OTW PTA DILATATION CATHETER
K110319 · LIT
Ev3, Inc.
Cardiovascular · 70d
Cleared Apr 14, 2011
VICOR PD2I ANALYZER
K101867 · DPS
Vicor Technologies, Inc.
Cardiovascular · 286d
Cleared Apr 13, 2011
ONESTEP ADULT MULTI-FUNCTION ELECTRODE
K110742 · MKJ
ZOLL Medical Corporation
Cardiovascular · 27d
Cleared Apr 13, 2011
MPS450 MULTIPARAMETER SIMULATOR
K103336 · DRT
Fluke Biomedical
Cardiovascular · 149d
Cleared Apr 12, 2011
WALDO PATIENT MONITOR
K110334 · DRG
Waldo Health
Cardiovascular · 67d
Cleared Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479 · DQX
Boston Scientific Corp
Cardiovascular · 49d
Cleared Apr 08, 2011
ATRICURE BIPOLAR SYSTEM
K110117 · OCL
AtriCure, Inc.
Cardiovascular · 80d
Cleared Apr 08, 2011
AGILIS ES STEERABLE INTRODUCER
K103083 · DYB
St Jude Medical
Cardiovascular · 171d
Cleared Apr 08, 2011
HYDROFIX VASO SHIELD
K101805 · OMR
Mimedx Group, Inc.
Cardiovascular · 284d
Cleared Apr 07, 2011
COMBITRANS MONITORING SETS AND ACCESSORIES
K102033 · DRS
B.Braun Melsungen AG
Cardiovascular · 262d
Cleared Apr 06, 2011
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K110499 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 43d
Cleared Apr 05, 2011
REVERSE MEDICAL REFLEX GUIDE CATHETER
K110055 · DQY
Reverse Medical Corporation
Cardiovascular · 85d
Cleared Apr 04, 2011
MODIFIED HD GUIDE CATHETER
K110483 · DQY
Concentric Medical, Inc.
Cardiovascular · 45d
Cleared Apr 04, 2011
CARDIOHELP SYSTEM
K102726 · DTQ
Maquet Cardiopulmonary, AG
Cardiovascular · 195d
Cleared Apr 01, 2011
TORFLEX TRANSSEPTAL GUIDING SHEATH
K102948 · DYB
Baylis Medical Co., Inc.
Cardiovascular · 178d
Cleared Mar 31, 2011
INTELLIVUE PATIENT MONITOR
K110622 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 28d
Cleared Mar 31, 2011
A SCOPE
K103499 · DQD
Active Signal Technologies, Inc.
Cardiovascular · 122d
Cleared Mar 25, 2011
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
K110526 · MKJ
ZOLL Medical Corporation
Cardiovascular · 29d
Cleared Mar 24, 2011
MOBILEECG SYSTEM
K103427 · DPS
Memtec Corp.
Cardiovascular · 122d
Cleared Mar 22, 2011
MUSTANG BALLOON DILATATION CATHETERS
K103751 · LIT
Boston Scientific
Cardiovascular · 89d