BEUDAMED
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    FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776172169·Cushing Needle Fcps Str Delicate

    Uro-Con® Texas-Style Male Ext Catheter, 35mm 2" Tube with Urofoam®-2 & Uro-Prep®

    FDA UDI
    UROCARE PRODUCTS, INC.·00792293122551·These male external catheters are commonly refe...

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377757·Integra® Jarit® Cushing Needle and Tissue Force...

    SCOTT'S SELECT K-FILES 6/pk 25mm # 35

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811225351·ENDODONTIC K-FILES (6/pack) Length: 25mm, Size:...

    SurgyCut

    FDA UDI
    U.S. SURGITECH INC.·00810014631646·SurgyCut Straight Blade with Handle Electrode, ...

    ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100

    FDA 510(k)
    FDA Class 1 ·Dental

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·May 16, 2013

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code FZW·September 22, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE SINGAPORE·Product code FRN·June 13, 2011

    UNKNOWN COBLATION ENT DEV

    FDA Adverse Event
    Injury ·ARTHROCARE CORP.·Product code GEI·October 20, 2022

    3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    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

    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

    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