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
5017–5040 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 16, 2011
AVIAFIT
K111720 · JOW
Flowmedic , Ltd.
Cardiovascular · 88d
Cleared Sep 16, 2011
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL...
K111490 · KRA
Ev3, Inc.
Cardiovascular · 108d
Cleared Sep 15, 2011
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
K112372 · DSP
Cardiac Assist, Maquet...
Cardiovascular · 29d
Cleared Sep 15, 2011
QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION...
K112360 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 29d
Cleared Sep 13, 2011
AMCOM COMMTECH MESSENGER
K112047 · MSX
Amcom Software,Inc.
Cardiovascular · 57d
Cleared Sep 13, 2011
THE UNBALLOON NON-OCCLUSIVE CATHETER
K110891 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 167d
Cleared Sep 12, 2011
REKA E100
K111438 · DPS
Reka Pte, Ltd.
Cardiovascular · 111d
Cleared Sep 09, 2011
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
K112327 · DSP
Cardiac Assist, Maquet...
Cardiovascular · 28d
Cleared Sep 09, 2011
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
K111704 · DQY
Avinger, Inc.
Cardiovascular · 84d
Cleared Sep 09, 2011
BIOTEQ ANGIOGRAPHIC CATHETER
K102633 · DQO
Bioteque Corp.
Cardiovascular · 361d
Cleared Sep 09, 2011
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
K101986 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 422d
Cleared Sep 08, 2011
OMNI PATIENT MONITOR
K112329 · MWI
Infinium Medical
Cardiovascular · 27d
Cleared Sep 02, 2011
PROSIM 4, PROSIM 6, PROSIM 8
K110429 · DRT
Fluke Biomedical
Cardiovascular · 199d
Cleared Sep 01, 2011
ALP 501 RB PUMP SYSTEM
K112311 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 21d
Cleared Sep 01, 2011
SAPPHIRE NC
K103808 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 246d
Cleared Aug 31, 2011
STEERABLE GUIDE CATHETER
K112239 · DRA
Abbott Vascular
Cardiovascular · 27d
Cleared Aug 26, 2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K112235 · MWI
Airstrip Technologies, LP
Cardiovascular · 22d
Cleared Aug 26, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K112182 · PNO
Angioscore, Inc.
Cardiovascular · 29d
Cleared Aug 25, 2011
VESOFLOW
K110977 · JOW
Caremed Supply, Inc.
Cardiovascular · 140d
Cleared Aug 24, 2011
NUVANT, MOBILE CARDIAC TELEMETRY
K111917 · QYX
Corventis, Inc.
Cardiovascular · 49d
Cleared Aug 24, 2011
ECG SERIES ELECTROCARDIOGRAPH
K111805 · DPS
Advanced Instrumentations, Inc.
Cardiovascular · 58d
Cleared Aug 24, 2011
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
K103706 · QYX
Applied Cardiac Systems, Inc.
Cardiovascular · 247d
Cleared Aug 24, 2011
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
K102511 · DTK
C.R. Bard, Inc.
Cardiovascular · 357d
Cleared Aug 19, 2011
MICROCATHETER
K112124 · DQO
Navilyst Medical, Inc.
Cardiovascular · 25d