BEUDAMED
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    AUTOBAND LIGATOR

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

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103180·MADDOX LASIK SPATULA DOUBLE ENDED

    Pipeline

    FDA UDI
    Micro Therapeutics, Inc.·00836462014794·Embolization Device

    PIPELINE

    FDA UDI
    Micro Therapeutics, Inc.·00847536008700·FA-71325-35 PIPELINE EMB DEVICE

    PIPELINE

    FDA UDI
    Micro Therapeutics, Inc.·00847536008687·FA-71325-35 PIPELINE EMB DEVICE

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030629·AILERON Static Posterior Fusion Core, 15mm Slot...

    Freedom Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215027346·

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030636·AILERON Static Posterior Fusion Plate, 15mm Slo...

    SMITHS- MEDICAL HYPODERMIC NEEDLE-PRO EDGE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FMI·September 28, 2021

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

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    BATTERY HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM

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

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    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