BEUDAMED
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    ABELSON CRICOTHYROTOMY CANNULA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BARCO

    FDA UDI
    Barco NV·05415334041639·MDSC-8527 SSTF

    STINGRAY LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

    Stingray LP Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GYNECARE TVT SECUR SYSTEM

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

    STINGRAY? LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code DTE·February 9, 2013

    IUNI/IDUO TIBIAL IMPACTOR

    FDA Adverse Event
    Malfunction ·CONFORMIS·Product code HSX·January 3, 2011

    COR/TRI POST STEM INSERT SHAFT

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·July 23, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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