BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925015005·OFF-CENTERED TORP 6MM LENGTH 0.84 MM DIAMETER D...

    Biogel

    FDA UDI
    Bosma Enterprises·10818634023954·Biogel PI Surgical 9.0 - 40 Pair/Box

    VARIAN HIGH ENERGY LINEAR ACCELERATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    3M TEGADERM SILVER

    FDA 510(k)
    FDA Unclassified ·Unknown

    BDRV CANN SCW SS P/T DIA4.5X60 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    BDRV CANN SCW SS P/T DIA4.5X52 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 27, 2023

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 24, 2013

    CENTRA

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 31, 2011

    9600EMI

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 13, 2023

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

    DISTAL FEMUR JTS

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·October 15, 2018

    TRU CC TIB INSERT SIZE 5, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 24, 2025

    DISTAL FEMUR JTS / PROXIMAL TIBIA MIG

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 7, 2015

    LOGIC CC FEMORAL SIZE 4, RIGHT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 12, 2023

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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