BEUDAMED
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    Lumipulse G whole PTH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319741764·Spratt (Brun) Bone Curette 6-1/2" (16.3cm), siz...

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402382·Reamer Template, Tibial Cone M/L

    MODIFICATION TO DASH 2500 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS

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

    AUTOPULSE® LIFEBAND

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code DRM·March 13, 2024

    AUTOPULSE® LIFEBAND

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code DRM·March 13, 2024

    MONOJECT

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD·Product code PNR·April 14, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    CARDINAL

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    BD 20 ML SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 20, 2020

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 6, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 26, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    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

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    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