BEUDAMED
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    MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO SPARC SLING SYSTEM

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

    CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FOZ·September 11, 2018

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 25, 2022

    BD INTIMA-II Y 22GAX1.00IN

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 3, 2023

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 20, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·June 10, 2011

    PUL GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 14, 2008

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015