7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ACCLAIM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RODEO Telescopic Nail
FDA 510(k)
FDA Class 2
·Orthopedic
UCA CREAM PRODUCT REFORMULATION
FDA 510(k)
FDA Class 2
·Neurology
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 27, 2014
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·November 14, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024