BEUDAMED
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    WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    9300

    FDA UDI
    HANS RUDOLPH, INC.·00874750008636·9316 INSP OCCL W/9301 LES 2600

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G2231123950·Iris scissors - light model, 4", straight blade...

    MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C.T.M. MOBILITY SCOOTER - MODEL HS 118

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2023

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 14, 2013

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·September 24, 2014

    S-SPECIAL-COMBINED-M4/TT4/H4.3

    FDA Adverse Event
    Injury ·IMPLANTECH ASSOCIATES, INC.·Product code LZK·May 23, 2011

    Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025