BEUDAMED
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    K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L

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

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517676986·Monolith Core, Ø12x29mm

    TrapIt

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLUCOMANAGER DATA MANAGEMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009

    CATGUT CHROMIC 2/0 (3.5) 100M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code GAL·November 27, 2018

    CATGUT CHROMIC 3 (7) 50M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code GAL·November 20, 2018

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·March 6, 2013

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011

    CATGUT PLAIN 3/0 (3) 100M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·May 28, 2020

    CATGUT PLAIN 1 (5) 75M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·July 20, 2020

    CATGUT PLAIN 1 (5) 75M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·February 10, 2021

    CATGUT CHROMIC 2 (6) 50M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·February 25, 2021

    MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·February 17, 2020

    CATGUT PLAIN 6 (10) 25M D2

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019

    CATGUT PLAIN 5 (9) 25M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·July 16, 2019

    CATGUT PLAIN 5 (9) 25M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·October 29, 2019

    CATGUT PLAIN 5 (9) 25M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012