BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Matrixx System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169595910·TRIAL 2171140 O25 IB 20MM 6 DEG 8X40

    Oticon

    FDA UDI
    Oticon A/S·05707131319142·OPN 1, BTE 13 PP 2.4G 105 C091

    Stainless Steel Femoral Nailing System

    FDA UDI
    ORTHOFIX SRL·18032568033762·FLEXIBLE REAMER D 14.0 MM

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045643·PrimaLIF LLIF PEEK Implant, 11mm X 26mm X 40mm,...

    MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DENTLIGHT ORAL EXAM LIGHT KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    VC10 PUMP, 115V

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HHK·January 2, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 14, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·July 1, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Injury ·BIOENTRICS CORP.·Product code LTI·September 18, 2008

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·August 15, 2024

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·August 15, 2024

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·August 15, 2024

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·August 15, 2024

    PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·August 11, 2020

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024