BEUDAMED
    32 results · 15ms · Sources: EU EUDAMED, US FDA

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    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MCX·March 8, 2022

    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MCX·March 8, 2022

    Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

    FDA Recall
    Open, Classified ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code MAX·December 15, 2024

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023

    ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·June 19, 2023

    ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·June 19, 2023

    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·June 19, 2023

    CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023

    CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840

    FDA Recall
    Open, Classified ·Western/Scott Fetzer Company·Product code ECX·October 16, 2021

    Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CCX·April 8, 2024

    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)

    FDA Recall
    Open, Classified ·MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany·Product code NFJ·September 9, 2025

    ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

    FDA Recall
    Open, Classified ·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024

    Alinity i Anti-HCV Reagent Kit, List Number 08P0521

    FDA Recall
    Open, Classified ·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Recall
    Open, Classified ·MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China·Product code RHP·October 26, 2021