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

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MDx-Chex for BC-GN

FDA 510(k)
FDA Class 2 ·Microbiology

ACE

FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950025343·6' DISS SWIVEL TO PURITAN MALE NITROUS OXIDE HO...

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573021376·INTRG WHISP MBT CUS 0T +8A 018 UR

SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARESCAPE MONITOR B650

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025

LYNX ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025

MECTALIF ANT - LAG

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

LYNX ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

SYNERGY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 13, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 17, 2013

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026

BD¿ ARTERIAL CANNULA WITH FLOWSWITCH

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·June 29, 2023

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022