7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VARELISA M2 ANTIBODIES
FDA 510(k)
FDA Class 2
·Immunology
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
KODAK X-OMAT MULTILOADER 300
FDA 510(k)
FDA Class 2
·Radiology
2.0MM THREADED GUIDE WIRE 230MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code DQX·February 6, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 21, 2014
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024