BEUDAMED
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    ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009083·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...

    Diagon

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030MO1022830·Trial, Bi-Convex, 12 x 34mm, 12mm

    SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 9, 2013

    NEUROSTIMULATOR RESTORE ADVANCED GENERATOR/BATTERY

    FDA Adverse Event
    Injury ·MEDTRONIC VASCULAR·Product code LGW·April 14, 2008

    FUSION ZILVER BILIARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FGE·April 11, 2011

    CENTURION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQC·January 3, 2018

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·August 29, 2022

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Model Number L101, ESSENTIO DR SL Pacemaker

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

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021