BEUDAMED
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    IllumiFlow Laser Cap

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613123338·Universal Keyhole Bracket, For Aluminum Trays, ...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776115739·Universal Keyhole Bracket

    Avalign

    FDA UDI
    Avalign Technologies, Inc.·00190776020590·Universal Keyhole Bracket

    PROMETEY, MODEL G1-03

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

    OSTENE CT, AOC CT, OSTEOTENE, CERETENE

    FDA 510(k)
    FDA Unclassified ·Unknown

    WEREWOLF RF 20000 CONTROLLER

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORP.·Product code GEI·June 29, 2020

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·June 11, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 16, 2014

    INNOVA 4100

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS·Product code MQB·July 12, 2011

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 27, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 11, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 19, 2022

    PEDICLE SCREW LATERAL CONNECTOR L150

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023

    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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