BEUDAMED
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    ZIMMER DISTAL RADIUS PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131260116·RIA, BTE 13 WL 85 STG

    PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IPLAN RT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 14, 2021

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·May 29, 2013

    AUTOSONIX ULTRA SHEARS SHORT

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code LFL·May 11, 2011

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 21, 2008

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021

    OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Osteomed, LLC·June 10, 2020

    OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

    SmartPath to dStream for 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