19 results · 23ms · Sources: EU EUDAMED, US FDA

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Disposable Endoscope Valves System

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

BD Difco™ QC Antigen Salmonella O Group C2

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902213314·Vial Qc Antigen Salmonella O Grp C2 1Ml

DEXACARE G4

FDA 510(k)
FDA Class 2 ·Radiology

BodySculp

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 10, 2012

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·August 10, 2012

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 3, 2014

4000CMS

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 1, 2013

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025

ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·November 23, 2021

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024