7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABBOTT VERTEX ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
17HQ901G-B
FDA 510(k)
FDA Class 2
·Radiology
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PERCUFLEX¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FGE·January 17, 2013
PATIENT SPECIFIC IMPLANT
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code GXN·December 8, 2010
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014
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