8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRA-ARTICULAR SURGICAL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Partial Pelvis Replacement
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575048328·3 hole flanges
3MENSIO WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
MICRESURGICAL TRAY, SM.,MED., & LG.
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·April 24, 2014
SCREW
FDA Adverse Event
Injury
·Product code HSB·November 6, 2012
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 5, 2015
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