BEUDAMED
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    IV ADMINISTRATION SET WITH HAND PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319705100·Thomas-Allis Tissue Forceps 8" (20cm), 6x7 teeth

    MEDLINE STRIDER MINI 4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ERGO IMAGING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    MAXZERO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

    GYNNIE OB-GYN STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·May 31, 2011

    SPECTRANETICS LEAD LOCKING DEVICE

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code MFA·May 31, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·October 3, 2014

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

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

    BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    DISTAL FEMUR JTS

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

    BD MAXZERO¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

    DISTAL FEMUR JTS / PROXIMAL TIBIA MIG

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

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: 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. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013