BEUDAMED
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    ORTHOLOC™ SPS Shoulder Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071917110S0·11mm O'Brien Curette 17" 7" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930719171100·O'Brien Curette 17" 11mm

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071917110C0·O'Brien Curette 17" length 11mm

    S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

    FDA 510(k)
    FDA Class 2 ·Hematology

    CERULEAU ELECTROSURGICAL PROBE

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

    JRNY BCS PAT RESRF RD 35 MM STD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GET·July 1, 2011

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 26, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 22, 2014

    JOURNEY POLY TIBIAL INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    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