BEUDAMED
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    VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402

    FDA 510(k)
    FDA Class 2 ·Radiology

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981352·anteriors; shade D2; mould CM2

    PROFILE MULTI-PLATFORM SYSTEM

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

    Loop System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UMBILICAL CATHETER

    FDA Adverse Event
    Malfunction ·VYGON·Product code FOS·February 17, 2021

    SPINE

    FDA Adverse Event
    Malfunction ·SYNTHES·Product code LYQ·February 27, 2013

    ENDOPATH STEALTH CIR STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code KOG·February 8, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 5, 2014

    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

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017