12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Digital flat panel detector
FDA 510(k)
FDA Class 2
·Radiology
ELMED
FDA UDI
ELMED INCORPORATED·00842180120877·5 MM DIA., 33 CM INSULATED CONE ELECTRODE, SIDE...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327090505·FRACTURE PLATE, CURVED, WITH BAR
HEART SYNC PEDIATRIC PHYSIO AED PAD
FDA 510(k)
FDA Class 3
·Cardiovascular
GAZELLE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·November 3, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 18, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
LAPIPLASTY SYSTEM S4A
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025
BD MICROLANCE¿3 NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 8, 2023
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015