11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
FDA 510(k)
FDA Class 2
·Cardiovascular
Headless Compression Screw
FDA UDI
I.T.S. GmbH·09120047299050·Headless Compression Screw, Cannulated, D=4.3mm...
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022
POWERHEART G5 AUTOMATIC AED
FDA Adverse Event
Malfunction
·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·October 6, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 12, 2015
BD SAFETYGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·February 26, 2019
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015