7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ANGIOGRAPHIC GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
DOVER URINE METER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OSFERION D
FDA 510(k)
FDA Class 2
·Dental
TPS HANDPIECE CORD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·April 30, 2014
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 10, 2012
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JHS·August 3, 2010
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024