BEUDAMED
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    ORTHO-1(NOT FINALIZED)

    FDA 510(k)
    FDA Class 2 ·Dental

    Mini Twin

    FDA UDI
    Rmo, Inc.·00885797652805·ROTH MINI LOW PROFILE 022 HK/3 5-5 20EA

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857531505·Trial Size 35°

    Diabetes Antigen Control (Unassayed)

    FDA UDI
    Mercodia AB·07350108630078·Mercodia Diabetes Antigen Control is designed t...

    Halyard

    FDA UDI
    O&M HALYARD, INC.·10680651411348·ACM,DRAPE,SRGDRP,-,L,40

    SAFIL VIOLET 4/0 (1.5) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B BRAUN SURGICAL S.A.·Product code GAM·January 3, 2014

    K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

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

    BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BENCHMARK GX, STAINER MODULE

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 18, 2024

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 27, 2011

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 15, 2013

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·June 3, 2011

    EVIS EXERA III VIDEO SYSTEM CENTER

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·November 11, 2022

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 15, 2017

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    ACCOLADE DR EL MRI (Model L331)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 6, 2025