BEUDAMED
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    TRIANGULAR BANDAGE CAT.#191

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Two Striper

    FDA UDI
    ABRASIVE TECHNOLOGY, INC.·B868C8020061·Dental Root Canal Post

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707066309·ELASTIC LIGATURE WIRE TRANSP 0,60mm

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515207837·Meyerhoffer Chal Curette, #3, 2.5mm

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482032213·Symmetry® Scissors, Micro, Curved, Sharp/Sharp,...

    ACUMED

    FDA UDI
    Acumed LLC·10806378090028·2.8 mm Locking Drill Guide 6-26 mm

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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

    LIFESHIELD ADDITIVE PIERCING PIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

    M2A MODULAR HEAD COMPONENT 32MM HEAD DIAMETER MINUS 3 MM NECK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·October 23, 2012

    COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013