BEUDAMED
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    SmartStart Air/Water and Suction Valves

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768475·GENUMEDI PSS GREEN III

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003197·MCK PATELLOFEMORAL IMPACTOR

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821604030·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383535625·Gutta Percha Points is used to root canal filin...

    Orthocryl®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011160403000·Orthocryl® LC, red/ orthodontic acrylics

    PTA (PROGRESSIVE TIBIAL ALIGNMENT)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 30, 2017

    PROMUS PREMIER¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 30, 2017

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025

    SUREFIX

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 13, 2011

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2013

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    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