BEUDAMED
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    BIAFINE WOUND DRESSING EMULSION

    FDA 510(k)
    FDA Unclassified ·Unknown

    CAPSTONE® L Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169133020·CAGE 2964240 CAPSTONE-L 6 DEG 12X40

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515251489·Tebbetts Fiber Optic Retractor, 9cm x 25mm blade

    SINGLE USE LAPARSCOPIC ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·February 21, 2012

    SYMMETRY¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·February 15, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 29, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·January 19, 2011

    M2A-MAGNUM PF CUP 54ODX48ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 24, 2021

    SINGLE LOCKING DRILL GUIDE

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code FZX·February 4, 2016

    M2A-MAGNUM MOD HD SZ 48MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 24, 2021

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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