BEUDAMED
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    THERMAGE CPT SYSTEM

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

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    AGXO

    FDA UDI
    Oticon A/S·05707131257185·H160, BTE 13 WL 85 SIL AGXO

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030834·AILERON Canted Static Posterior Fusion Plate, 1...

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030827·AILERON Canted Static Posterior Fusion Core, 11...

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PRISMA M60/M100 SETS

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

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·January 6, 2020

    SLOTTED-HAMMER 400G CAN BE MOUNTED

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZY·May 29, 2013

    TRIAGE CARDIAC PROFILER

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·June 13, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 22, 2008

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·September 2, 2020

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 25, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    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

    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