40 results · 31ms · Sources: EU EUDAMED, US FDA

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HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO

FDA 510(k)
FDA Class 2 ·Immunology

XPS® HANDPIECE - VISAO®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015

CAPTIA(R) RUBELLA-G

FDA 510(k)
FDA Class 2 ·Microbiology

MOTO-MED RF-II AND PICO

FDA 510(k)
FDA Class 1 ·Physical Medicine

XPS® HANDPIECE - VISAO®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016

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

XPS HANDPIECE - VISAO

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021

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

PORTEX 8.0MM VOCALAID TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL INTERNATIONAL LTD·Product code BTO·June 24, 2014

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013

LOW RECIRCULATION VOLUME APDSET W/CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 10, 2011

DRILL 3334800 VISAO 80K HANDPIECE

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013

XPS® HANDPIECE - VISAO®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017

XPS® HANDPIECE - VISAO®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017