10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TECHNICON PARACUT
FDA 510(k)
FDA Class 1
·Pathology
PULSE
FDA UDI
Nuvasive, Inc.·00195377058539·PULSE LessRay Tablet, Labeled
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ELASTIC IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012
GEMSTAR PAIN MGE SNG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 25, 2014
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·September 14, 2010
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 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