BEUDAMED
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    Jumong Series

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENMATRIX

    FDA UDI
    Davol Inc.·00801741128981·XenMatrix AB Surgical Graft, 8cm x 16 cm

    HHM

    FDA UDI
    Oticon A/S·05707131280800·H160V2, BTE 13 WL 100 SGR HHM

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197541893·RZ Tebbet Breast Retractor 150x16...

    VITEK 2 GRAM POSITIVE MEROPENEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PK SUPERPULSE SYSEM GENERATOR MODEL 744000

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

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    NEXGEN ALL POLY PATELLA SIZE 29 MM

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·September 20, 2018

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    INVACARE TAYLOR STREET·Product code IOR·October 8, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·June 6, 2013

    ISERT ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·June 21, 2011

    NEXGEN NONAUGMENTABLE STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·September 20, 2018

    NEXGEN FEMORAL COMPONENT SIZE D LEFT

    FDA Adverse Event
    Injury ·ZIMMER ORTHOPAEDIC MFG. LTD.·Product code NJL·September 20, 2018

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    TREVO XP PROVUE 4MM X 30MM

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

    TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

    FDA Recall
    Terminated ·Theralase Inc.·Product code NHN·September 26, 2019

    TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

    FDA Recall
    Terminated ·Theralase Inc.·Product code NHN·September 26, 2019

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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