7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TDX THEOPHYLLINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SURGICAL FACE MASK (Ear Loops and Tie-on)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 25, 2014
SMARTSET MV ENDURANCE 80G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·November 15, 2012
QUANTUM MAVERICK BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·September 14, 2010
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