11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)
FDA 510(k)
FDA Class 2
·Dental
GENESIS II
FDA 510(k)
FDA Class 2
·Radiology
BESTALOY
FDA 510(k)
FDA Class 2
·Dental
BHR ACETABULAR CUP 60MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·February 19, 2019
BD LEUCOCOUNT¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·June 21, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
2520274-2013-04481
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·July 18, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PSZ·March 7, 2025