BEUDAMED
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    Water-soluble Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TempoCem®NE Smartmix

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2121040·Temporary cement automix system, eugenol free. ...

    NA

    FDA UDI
    Synthes GmbH·10886982151780·3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RE...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154262748·DRILL, WL 4MM, STRYKER SHAFT

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM

    ELECSYS N-MID OSTEOCALCIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BD BBL COLUMBIA CNA AGAR 500 G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JSJ·December 6, 2024

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·January 16, 2014

    MESH-COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 24, 2008

    TAXUS¿ ELEMENT¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 15, 2011

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 8, 2013

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    IMMULITE 1000 TURBO TROPONIN 1

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MMI·April 21, 2014

    BOTTLE COLUMBIA CNA AGAR BBL 500G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·August 4, 2025

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 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