BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    H.N. TOTAL HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083014933·Fixed, 10 electrode, MPB, 5-5-5-20-3-3-3-3-3mm ...

    Printed Lower Crown Pack for Herbst LR8 8mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015940·

    TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020

    HEART-EXERCISE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3.5 MM LAPAROSCOPE (LG100, LG103)

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

    M2A-TAPER LINER SZ 41/28

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

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 12, 2010

    SCULPTRA

    FDA Adverse Event
    Injury ·AVENTIS PHARMA GRUPPO LEPETIT S.R.L.·Product code LMH·January 3, 2013

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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