13 results · 20ms · Sources: EU EUDAMED, US FDA

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INTAVENT LARYNGEAL MASK

FDA 510(k)
FDA Class 1 ·Anesthesiology

ZIPTIGHT

FDA UDI
Biomet Orthopedics, LLC·00880304478404·

ABBOTT IMX FREE T4

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INSTANT ICE PACK

FDA 510(k)
FDA Class 1 ·Physical Medicine

ZIPTIGHT ACROMIOCLAVICULAR JOINT 1 ZIPLOOP

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBI·September 19, 2017

RAPID EXCHANGE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code GCJ·January 9, 2013

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 22, 2010

LIVIAN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

AC JOINT PROCEDURE SYSTEM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code LXH·December 4, 2020

STEALTHSTATION¿ S8 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·February 7, 2025

BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

FDA Recall
Open, Classified ·Biomet, Inc.·Product code MBI·September 23, 2025

BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

FDA Enforcement
Class II ·Ongoing·Biomet, Inc.·October 29, 2025

Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·June 1, 2016