BEUDAMED
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    ENAMIC

    FDA 510(k)
    FDA Class 2 ·Dental

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664222697·ULTRA SHEER 30-40 MM HG THIGH W/LACE BAND CLOSE...

    CORNEAL TREPHINE HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896013209·CORNEAL TREPHINE HANDLE

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970492·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970485·

    COATED VICRYL* (POLYGLACTIN 910) SUTURE

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

    ELECSYS IGE CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 30, 2026

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·September 18, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 13, 2011

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022

    Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020