10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SKED STRETCHER
FDA 510(k)
FDA Class 1
·General Hospital
COATED ISOLATION GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
IDENTITY ADX DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 22, 2014
HEART START XL
FDA Adverse Event
Malfunction
·AGILENTTECHNOLOGIES, INC·Product code MKJ·November 20, 2012
AIM-ARM F/LFN
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·July 11, 2016
AIMING ARM
FDA Adverse Event
Injury
·SYNTHES USA·Product code LXH·July 13, 2016
STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·July 11, 2016
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024