33 results · 29ms · Sources: EU EUDAMED, US FDA

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PAIN CARE 2000

FDA 510(k)
FDA Class 2 ·General Hospital

NUOVOCATH

FDA 510(k)
FDA Class 2 ·General Hospital

Tyece OTC EMS System

FDA 510(k)
FDA Class 2 ·Physical Medicine

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

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 27, 2014

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·February 28, 2013

TOTAL HIP BALL 32MM +0

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 31, 2011

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