9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
FDA 510(k)
FDA Class 1
·Anesthesiology
TRABECULAR METAL PRIMARY HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Falck Medical Multifunction Tonometer, FAT1
FDA 510(k)
FDA Class 2
·Ophthalmic
CAPSUREFIX
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 9, 2013
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2014
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024