BEUDAMED
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    Gobble Surgical

    Manufacturer
    🇵🇰 Pakistan·1 Importer

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·April 3, 2023

    KHANG BAO INTERNATIONAL KFT

    Authorized representative
    🇭🇺 Hungary·119 Manufacturers·1262 Devices

    La Centrale Médicale

    Importer
    🇫🇷 France·19 Manufacturers

    PWRD 29MM CURVED CIRCULAR, 18CM SHAFT

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 5, 2020

    Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·May 2, 2018

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code MFK·October 1, 2025

    Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code DZE·March 13, 2018

    IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code HBE·July 17, 2025

    Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code LXH·October 16, 2009

    IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·September 3, 2025