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
4441–4464 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 28, 2013
CIRCUFLOW 5150
K123959 · JOW
Devon Medical, Inc.
Cardiovascular · 69d
Cleared Feb 28, 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
K123707 · DQX
Cook, Inc.
Cardiovascular · 87d
Cleared Feb 27, 2013
DIGITAL ELECTROCARDIOGRAPHS
K123816 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 77d
Cleared Feb 27, 2013
VITAL SYNC SYSTEM
K123002 · MWI
Covidien, Formerly Nellcor Puritan...
Cardiovascular · 153d
Cleared Feb 22, 2013
MRI PATIENT MONITORING SYSTEM (MODEL 865214)
K124061 · MWI
Invivo Corporation
Cardiovascular · 53d
Cleared Feb 22, 2013
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA...
K123187 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 134d
Cleared Feb 22, 2013
VPULSE
K122640 · JOW
Cothera, LLC
Cardiovascular · 177d
Cleared Feb 21, 2013
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K124060 · DSI
Medicalgorithmics S.A.
Cardiovascular · 52d
Cleared Feb 21, 2013
PERCUTANEOUS INTRODUCER KIT
K123974 · DYB
Teleflex, Inc.
Cardiovascular · 57d
Cleared Feb 14, 2013
CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
K123647 · JOW
Devon Medical, Inc.
Cardiovascular · 79d
Cleared Feb 14, 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · DYB
Cook Incorporated
Cardiovascular · 121d
Cleared Feb 14, 2013
ECG CHECK
K122184 · DXH
Cardiac Designs, LLC
Cardiovascular · 206d
Cleared Feb 14, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
K120675 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 346d
Cleared Feb 14, 2013
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
K120673 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 346d
Cleared Feb 12, 2013
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE...
K130209 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 14d
Cleared Feb 12, 2013
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
K123544 · LIT
Ev3, Inc.
Cardiovascular · 85d
Cleared Feb 08, 2013
PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
K123308 · JOW
Albahealth, LLC
Cardiovascular · 107d
Cleared Feb 08, 2013
COMPACT DIGITAL BLOOD PRESSURE MONITOR
K122810 · DXN
Thermor , Ltd.
Cardiovascular · 148d
Cleared Feb 07, 2013
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY...
K123216 · DPT
Aimago SA
Cardiovascular · 115d
Cleared Feb 07, 2013
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587 · DRC
St Jude Medical
Cardiovascular · 167d
Cleared Feb 05, 2013
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · DSY
LeMaitre Vascular, Inc.
Cardiovascular · 35d
Cleared Feb 05, 2013
CARDEASCREEN
K123217 · DPS
Cardea Associates, Inc.
Cardiovascular · 113d
Cleared Jan 31, 2013
V8 TRANSLUMINAL BAV CATHETER
K123111 · OZT
Intervalve, Inc.
Cardiovascular · 120d
Cleared Jan 30, 2013
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK...
K123279 · LOX
Abbott Vascular
Cardiovascular · 100d