9 results
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18ms
·
Sources: EU EUDAMED, US FDA
ALTAIR EYEWEAR FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 3, 2024
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PUMP MMT-522RNAS PRDGM INS SK EN RC
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·December 8, 2010
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 28, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·July 14, 2014
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014