BEUDAMED
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    BARLE TISSUE ADHESIVE 2

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MINICAT DENTOCAT

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY

    FDA 510(k)
    FDA Unclassified ·Unknown

    XORAN

    FDA Adverse Event
    Malfunction ·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 27, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 25, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 3, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 26, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 29, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·ANGEL KISS LLC·Product code FTC·February 2, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 4, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    TOTALCARE

    FDA Adverse Event
    HILL-ROM, INC.·Product code FNL·June 13, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·July 31, 2008

    GMK PS CEMENTED FEMUR SIZE 3 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 2, 2015

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015