BEUDAMED
    10,000 results · 74ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    8015 ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 24, 2020

    UNK_CARTRIDGE_EMERALD_UNKNOWN

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·April 28, 2021

    UNFOLDER EMERALDAR INSERTION HANDPIECE

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·April 7, 2021

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

    UNK-CARTRIDGE_EMERALD

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code KYB·April 7, 2026

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

    Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code KYB·January 23, 2009

    STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

    FDA Recall
    Terminated ·Staar Surgical Co.·Product code KYB·May 2, 2016

    Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code KYB·November 13, 2024

    MicroSTAAR Injector, MSI-PF Packed ten per box.

    FDA Recall
    Terminated ·Staar Surgical Co Inc·Product code KYB·April 21, 2004

    MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)

    FDA Recall
    Terminated ·Staar Surgical Co Inc·Product code KYB·January 6, 2004

    MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF

    FDA Recall
    Terminated ·Staar Surgical Co Inc·Product code KYB·February 23, 2004

    MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code KYB·July 7, 2008

    Lens, Guide, Intraocular

    FDA classification
    FDA Class 1 ·Lens, Guide, Intraocular

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·December 27, 2016

    MICROSTAAR INJECTOR

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code KYB·October 14, 2016

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·October 13, 2016