BEUDAMED
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    MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574584·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00196365849474·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00196365849221·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00196365848880·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574560·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574577·

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 15, 2023

    TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTO-DRIVE LAG SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    TENDRIL DX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE SJ·Product code JPA·March 14, 2008

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 13, 2021

    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