BEUDAMED
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    Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments

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

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

    Oticon

    FDA UDI
    Oticon A/S·05707131339713·SIYA 1, KIT 312 NFM 85 R C001

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111246470·BROPHY DRESSING FCP CVD 8"

    ELLUME COVID-19 HOME TEST

    FDA Adverse Event
    Malfunction ·ELLUME LIMITED·Product code QKP·December 22, 2021

    CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALPHA I INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·MENTOR UROLOGY, INC.·Product code FHW·February 28, 1997

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·October 1, 2008

    PROVISIONAL LINER LOCKING SCREW

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·July 22, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

    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