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

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    STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.

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

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517962249·Brigade Lateral Trial, 9x34x28mm 25°

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515229198·Pick, .33 point ang 45deg up, 7"

    ADVIA CENTAUR RUBELLA IGG ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AXIOM FASCIAL CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ADULT BREATHING CIRCUIT DUAL HEATED

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·January 21, 2025

    M2A 38MM MOD HD -6MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 30, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 12, 2010

    BARDIA BEDBAG

    FDA Adverse Event
    Malfunction ·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code KNX·December 14, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021