7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UREA NITROGEN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROGESTERONE SYSTEM BY EIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 16, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2010
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 14, 2012
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