BEUDAMED
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    SAS SALMONELLA H G,P,U ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

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

    DAILIES VISITINT AQUACOMFORT PLUS

    FDA Adverse Event
    Injury ·CIBA VISION CORPORATION·Product code LPL·February 8, 2013

    RHAPSODY +

    FDA Adverse Event
    Malfunction ·SORIN CRM·Product code NVZ·December 15, 2010

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 15, 2014

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Injury ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 1, 2021

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2024

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2022

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2022

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 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