8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PrimmaArt
FDA 510(k)
FDA Class 2
·Dental
MILAGRO
FDA UDI
Medos International Sàrl·10886705026418·MILAGRO ADVANCE INTERFERENCE SCREW Non-absorbab...
MULTIFUNCTIONAL SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 12, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·September 1, 2011
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·July 17, 2013
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·August 29, 2012