BEUDAMED
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    Innomed NPWT Silicone Foam Dressing

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

    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·October 14, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012