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

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    Mako Shoulder Application (1.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    Medos International Sàrl·10886705032365·

    Artman Instruments

    FDA UDI
    Wise Linkers, LLC·D1272423731·Dental 2.5 Ring Aspirating Syringe 1.8ml ARTMAN

    Evolve Masters

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215002336·

    Evolve Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215051969·

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·June 25, 2010

    GALEO FOCUS GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ULTRACISION BLADES 5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 11, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 10, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 23, 2013

    EXP DI POLYAXL SCRW 7 X 45MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·June 17, 2020

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025