BEUDAMED
    3,046 results · 28ms · Sources: EU EUDAMED, US FDA

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    UNKNOWN_INSTRUMENTSTIRE_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFA·October 26, 2017

    DRILL 3334800 VISAO 80K HANDPIECE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ERL·July 3, 2013

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·October 21, 2016

    INFERIOR TURBINATE BLADE 2.9MM

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code EQJ·July 12, 2013

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code EQJ·August 8, 2014

    Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur PART NUMBER AND LOT NUMBER IS LISTED ON POUCH AND BOX LABEL.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code EQJ·January 25, 2002

    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code EQJ·August 31, 2021

    Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code EQJ·July 5, 2024

    Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

    FDA Recall
    Open, Classified ·Gyrus ACMI, Inc.·Product code EQJ·August 3, 2017

    XPS® BUR - HIGH SPEED RAD®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·October 26, 2016

    XPS® BLADE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·November 16, 2016

    XPS® BUR - IPC® M5 AND M4 30K

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·October 25, 2016

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·July 10, 2015

    XPS® BUR - UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC·Product code EQJ·July 28, 2015

    XPS® BLADE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code EQJ·September 25, 2015

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·September 21, 2015

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·August 5, 2015

    DRILL BURR 7777 DIA 2.0MM LEMOINE

    FDA Adverse Event
    Injury ·INTEGRA MICROFRANCE S.A.S.·Product code EQJ·September 9, 2015

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·July 2, 2015

    ROUND FLUTED BUR

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND LTD.·Product code EQJ·February 22, 2012