BEUDAMED
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    Orfit Industries

    FDA UDI
    Orfit Industries NV·05420028729151·AIO Base Plate in CFL version Hexapod Base plat...

    IMAGE1 S HX-P FI

    FDA Adverse Event
    Malfunction ·KARL STORZ SE & CO. KG·Product code FET·June 20, 2024

    IMAGE1 S HX-P FI

    FDA Adverse Event
    Injury ·KARL STORZ IMAGING·Product code FET·February 26, 2025

    BACFIX ROD BENDER (2 HAND)

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code HXW·August 9, 2016

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020

    2.0MM HAND PLATE BENDER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HRS·April 23, 2018

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·July 19, 2021

    FOOT DOUBLE FAST GUIDE BENDER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LXH·August 21, 2018

    2.0MM HAND PLATE BENDER END

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code LXH·July 21, 2017

    2.0MM HAND PLATE BENDER

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code LXH·July 21, 2017

    POL 5.5 TI ROD BENDER

    FDA Adverse Event
    Malfunction ·BIOMET SPINE - BROOMFIELD·Product code HXW·August 10, 2016

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·February 2, 2023

    1.5MM VA LOCKING DOUBLE DRILL GUIDE/WITH CONE F/2.0 VAL PL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZX·May 22, 2024

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·September 14, 2020

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·September 14, 2020

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·September 28, 2022

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·December 20, 2022

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·January 8, 2021

    IN-SITU BENDING & TWISTING HANDLE/120°

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HXP·May 8, 2014