34 results · 33ms · Sources: EU EUDAMED, US FDA

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OLYMPUS LIPASE REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FILM DIGITZER, MODEL 2908 MAMMO PRO

FDA 510(k)
FDA Class 2 ·Radiology

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

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

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 20, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 18, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 3, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 5, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 16, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 28, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 17, 2026

UNKNOWN ZIMMER KNEE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·February 13, 2013

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS INC·Product code MUZ·December 20, 2010

RESOLUTION CLIP CLIPPING DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·July 29, 2014

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 23, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 30, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·July 30, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·September 12, 2025

ARCHITECT TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 9, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·June 19, 2025