BEUDAMED
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    Neuromaster G1 MEE200

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

    AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVITA WRIST TYPE BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 3, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·June 21, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    PKG, MIXTER FORCEPS, P/N 0250080249. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023