13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Easi-Vue embolic microspheres System
FDA 510(k)
FDA Class 2
·Cardiovascular
ELMED
FDA UDI
ELMED INCORPORATED·00842180121034·5 MM DIA., 33 CM INSULATED KNIFE ELECTRODE WITH...
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134590·LATERAL,PSOAS RETRACTOR,HANDLE
AKUPORT M1
FDA 510(k)
FDA Class 2
·Neurology
GYRUS AMCI PK BUTTON ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VDW.SILVER RECIPROC
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EBW·January 12, 2026
KERAMOS CERAMIC ON CERAMIC ACETABULAR LINER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWB·October 31, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·August 23, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
SMR HUMERAL HEAD Ø50 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·March 11, 2024
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·January 2, 2026
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·December 3, 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