9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 1, TAPER 12/14
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·November 7, 2018
JETTA JR. HYDRO MASSAGE
FDA 510(k)
FDA Class 2
·Physical Medicine
CAP WASHER ASSEMBLY
FDA 510(k)
FDA Class 2
·Orthopedic
AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 2, TAPER 12/14
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·November 7, 2018
Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·December 26, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
ACCENT DR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 10, 2011
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·July 24, 2014