FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
15049–15072 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 21, 1985
BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER
K850925 · DWF
American Bentley
Cardiovascular · 77d
Cleared May 21, 1985
MICROCOR ECG MONITOR
K851325 · DRT
Microcor, Inc.
Cardiovascular · 47d
Cleared May 21, 1985
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
K851665 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared May 16, 1985
SYNKARA
K840445 · DRX
Lectec Corp.
Cardiovascular · 472d
Cleared May 16, 1985
RECOMED BLOOD-FLOW METER H236-052-02
K840522 · DPW
Litton Medical Electronics
Cardiovascular · 464d
Cleared May 16, 1985
MODEL T 101 CLINICAL TRANSMITTER
K842435 · DXH
Biometric Products, Inc.
Cardiovascular · 330d
Cleared May 16, 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731 · DRT
Kontron Instruments, Inc.
Cardiovascular · 163d
Cleared May 16, 1985
OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
K844800 · DQO
Vas-Cath of Canada , Ltd.
Cardiovascular · 156d
Cleared May 16, 1985
DESERET INTRODUCER SET
K844840 · DYB
Parke-Davis Co.
Cardiovascular · 155d
Cleared May 16, 1985
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 143d
Cleared May 16, 1985
MEDWATCH 400 CARDIAC CENTRAL NURSES STATION
K850135 · DRT
Medwatch Systems, Inc.
Cardiovascular · 122d
Cleared May 16, 1985
RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH
K850322 · DPS
Eaton Medical Group
Cardiovascular · 108d
Cleared May 16, 1985
TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH
K850323 · DPS
Eaton Medical Group
Cardiovascular · 108d
Cleared May 16, 1985
ACCUTRACKER HEART-RATE MONITOR
K850867 · DXN
Eutectic Electronics, Inc.
Cardiovascular · 76d
Cleared May 16, 1985
BP/CLINIC SYS MEASUREMENT, BP NON-INVASIVE
K850893 · DXN
Sun Dance Technology, Inc.
Cardiovascular · 73d
Cleared May 16, 1985
CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX
K851004 · DTP
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared May 16, 1985
AMERICAN BENTLEY OXYGENATOR MAX-2
K851035 · DTZ
American Bentley
Cardiovascular · 64d
Cleared May 16, 1985
NORELCO BLOOD PRESSURE METER
K851049 · DXN
Philips Park
Cardiovascular · 63d
Cleared May 16, 1985
UMI ANGIOGRAPHIC CATHETER
K851088 · DQO
Universal Medical Instrument Corp.
Cardiovascular · 59d
Cleared May 16, 1985
VASOSCREEN IMPEDANCE PLETHYSMOGRAPH
K851102 · DQB
Sonicaid, Inc.
Cardiovascular · 58d
Cleared May 16, 1985
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · DYB
Teleflexmedical, Inc.
Cardiovascular · 56d
Cleared May 16, 1985
PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH
K851322 · DPS
Parexel Intl. Corp.
Cardiovascular · 44d
Cleared May 16, 1985
COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE
K851699 · DXY
Cook Pacemaker Corp.
Cardiovascular · 22d
Cleared May 16, 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861 · DXY
Pacesetter Systems
Cardiovascular · 20d