BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Shina Syringe; Shina Safety Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111148712·SKLARLITE MAYO DISS STR 6.75

    Brisbane ALIF Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215018245·

    PLUS ORTHOPEDICS CEMENTED HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANKER DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA)

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·July 9, 2024

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 12, 2008

    PACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH. LTD. / HUNTINGTON·Product code MFK·August 26, 2011

    PAGEWRITER

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DPS·June 25, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026