BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C.T.M. MOBILITY SCOOTER MODEL # HS-320

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    TRANSVAGINAL MESH

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON·Product code FTL·March 26, 2013

    SIMILE

    FDA Adverse Event
    Injury ·PENTRON CLINICAL·Product code EBF·March 17, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·March 28, 2008

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    PT HYBRID GLEN POST REGENEREX

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 3, 2023

    MD HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 3, 2023

    VERSA-DIAL/COMP TI STD TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 3, 2023

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 25, 2013

    FREEDOM ALL POLY CUP 50MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWZ·October 31, 2012

    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.

    FDA Enforcement
    Class II ·Terminated·Tedan Surgical Innovations Llc·September 26, 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