27 results · 25ms · Sources: EU EUDAMED, US FDA

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ARCHITECT HAVAB-G

FDA 510(k)
FDA Class 2 ·Microbiology

ARCHITECT HAVAB-IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·May 8, 2026

ARCHITECT HAVAB-IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·April 3, 2026

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·August 20, 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

ARCHITECT HAVAB-IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·February 4, 2026

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

BIO-MODULAR SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304204478·

REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP

FDA 510(k)
FDA Class 2 ·Dental

MEDIPLUS SINGLE USE GI MANOMETRY CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

POLARIS 6.35 IMPLANTS

FDA Adverse Event
Malfunction ·EBI, LLC·Product code MNI·June 16, 2009

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

NITE GUARD

FDA Adverse Event
Malfunction ·RANIR CORPORATION·Product code OBR·May 1, 2014

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·May 15, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 2, 2011

ANTI-B (MURINE MONOCLONAL) SERIES 3

FDA Adverse Event
Malfunction ·IMMUCOR·Product code KSZ·July 6, 2009