13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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