BEUDAMED
    84 results · 24ms · 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 FDA Recall ×

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code LXH·April 13, 2022

    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 15, 2017

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    FDA Recall
    Terminated ·Medacta Usa·Product code KRO·April 17, 2015

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KRO·May 19, 2017

    Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024

    Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JWH·October 24, 2017

    Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    FDA Recall
    Terminated ·Medacta Usa·Product code HSB·September 22, 2014

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code LXH·June 26, 2017

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Recall
    Terminated ·GSK Consumer Healthcare·Product code N/A·April 25, 2016

    ClubMax Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Logolas Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Burstberry Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Atom Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Spectrum Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code BRX·July 10, 2019

    Maxim Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·April 22, 2024

    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·April 22, 2024

    ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·April 22, 2024