8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
AKRO-SIL FOLEY KIT 5CC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXCELSIUS GPS
FDA 510(k)
FDA Class 2
·Neurology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 3, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·April 24, 2014
HUDSON NEONATAL CIRCUIT, DUAL HTD LIMB, 60 IN
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BZO·September 26, 2012
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 28, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024