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    JOURNEY II Unicompartmental Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Orthos

    FDA UDI
    ORMCO CORPORATION·00889989029963·ORTHOS CM SST 018 X 025 UPSM PK10

    Symetri Clear

    FDA UDI
    ORMCO CORPORATION·00889989082906·U2L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198956·AK3 Congruent Insert Trial Size 2, 11mm

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930719121100·O'brien Custom Curette 11mm

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191211801·IN-OVATION® mini EURO 018/UL1 17T 4A

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191211001·IN-OVATION® mini Base Rx 018/UL1 12T 5A

    EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CELL-DYN 22 PLUS CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    TORSION ADAPTER

    FDA Adverse Event
    Injury ·OTTO BOCK HEALTHCARE PRODUCTS GMBH·Product code ISY·December 22, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 26, 2013

    MEDTRONIC ANEURX (FLEXIBLE) STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 29, 2011

    PROLIEVE THERMODILATATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 26, 2008

    cobas 8000 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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018