19 results · 22ms · Sources: EU EUDAMED, 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