BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    UNKNOWN BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020

    UNKNOWN BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020

    UNKNOWN BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020

    UNKNOWN BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020

    SHEA MIDDLE EAR MICRODRILL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    XPS® BUR - UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·March 9, 2017

    DRILL 3055601 SKEETER OTO-TOOL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC·Product code ERL·January 11, 2013

    XPS® BUR - UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·March 8, 2017

    tmCMF Solution

    FDA 510(k)
    FDA Class 2 ·Dental

    MYOLIGHT

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKONWN DEPUY BROACH

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 27, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 15, 2012

    SUPER POLIGRIP ULTRA FRESH CREAM

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·September 8, 2010

    Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018