19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LVIS NeuroMatch
FDA 510(k)
FDA Class 2
·Neurology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111147876·METZ LAHEY DEL STR 4 1/2"
TriVerse Monoblock Pin Puller
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215109028·
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
FDA 510(k)
FDA Class 2
·Cardiovascular
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 25, 2022
FR MARSEILLE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
SITTER II
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·July 13, 2011
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSH·November 4, 2008
DELTA CER HEAD 12/14 36MM +5
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LZO·July 12, 2013
UNK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·November 26, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·July 22, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·January 23, 2026
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·January 16, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025