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
7417–7440 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 19, 2005
MODIFICATION TO: RADIANALYZER, MODEL 12711
K042628 · DQK
Radi Medical Systems AB
Cardiovascular · 114d
Cleared Jan 13, 2005
PFA PATCH
K041736 · DXZ
Peritec Biosciences, LLC
Cardiovascular · 199d
Cleared Jan 13, 2005
PMP4 SELFCHECK ECG
K042254 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 146d
Cleared Jan 13, 2005
CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
K042849 · DQK
Cardiobiomedical Corporation
Cardiovascular · 90d
Cleared Jan 13, 2005
ANEROID SPHYGMOMANOMETER, MODEL BK2002
K043286 · DXQ
Wenzhou Bokang Instrument Co.,Ltd
Cardiovascular · 48d
Cleared Jan 12, 2005
FLOWMEDIC, MODEL 220
K042217 · JOW
Flowmedic (Israel), Ltd.
Cardiovascular · 149d
Cleared Jan 12, 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 30d
Cleared Jan 12, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 10, 2005
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K042624 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 105d
Cleared Jan 10, 2005
VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
K042657 · MUD
Vioptix, Inc.
Cardiovascular · 104d
Cleared Jan 10, 2005
MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
K043354 · DRT
Invivo Research, Inc.
Cardiovascular · 35d
Cleared Jan 07, 2005
PROXIS SYSTEM, MODEL EPS 101
K042117 · DQY
Velocimed, Inc.
Cardiovascular · 155d
Cleared Jan 06, 2005
READMYHEART
K042814 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 86d
Cleared Jan 06, 2005
CARDIOFAX CE, MODEL PEA-1110K
K042827 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 86d
Cleared Jan 06, 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 31d
Cleared Jan 05, 2005
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K043552 · DSY
Vascutek, Ltd.
Cardiovascular · 9d
Cleared Dec 28, 2004
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
K042381 · DQY
Acumen Medical, Inc.
Cardiovascular · 118d
Cleared Dec 23, 2004
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
K043276 · MHX
Datex-Ohmeda
Cardiovascular · 27d
Cleared Dec 22, 2004
12-LEAD GLOVE
K033559 · DRX
Ineedmd
Cardiovascular · 406d
Cleared Dec 22, 2004
Lysus Infusion System
K043269 · QEY
Ekos Corp.
Cardiovascular · 26d
Cleared Dec 17, 2004
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · DQX
Cordis Corp.
Cardiovascular · 284d
Cleared Dec 17, 2004
TORAYGUIDE GUIDEWIRE
K042370 · DQX
Toray Industries (America), Inc.
Cardiovascular · 108d
Cleared Dec 17, 2004
MODIFICATION TO SHORT INTRODUCER SHEATH
K042399 · DYB
Rex Medical, L.P.
Cardiovascular · 105d
Cleared Dec 17, 2004
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
K042734 · KRH
St. Jude Medical, Inc.
Cardiovascular · 77d