BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    COSINE™ Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464034680·Bernafon Oasisnxt 2022.1.0

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017972·K-Wire, Single Ended, Trocar Point, Diameter Si...

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")

    3I PATIENT-SPECIFIC OVERDENTURE BAR

    FDA 510(k)
    FDA Class 2 ·Dental

    TRANSONIC HCM 103 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014

    EAGLE PLUS ONE LEVEL PLATE 17MM

    FDA Adverse Event
    Malfunction ·DEPUY RAYNHAM·Product code KWQ·September 6, 2011

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE·Product code CBK·July 11, 2013

    Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.

    FDA Recall
    Terminated ·Alto Development Corp·Product code LRY·October 23, 2017

    A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.

    FDA Recall
    Terminated ·Alto Development Corp·Product code JDQ·September 10, 2019

    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

    FDA Recall
    Terminated ·Alto Development Corp·Product code LDF·June 21, 2019

    A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.

    FDA Recall
    Terminated ·Alto Development Corp·Product code JDQ·September 10, 2019

    A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.

    FDA Recall
    Terminated ·Alto Development Corp·Product code JDQ·September 10, 2019

    A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.

    FDA Recall
    Terminated ·Alto Development Corp·Product code JDQ·September 10, 2019

    A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.

    FDA Recall
    Terminated ·Alto Development Corp·Product code JDQ·September 10, 2019

    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