BEUDAMED
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    FULL AUTO TONOMETER MODEL TX-20

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04250317337283·

    Anterior Clavicle Plate, Medial

    FDA UDI
    I.T.S. GmbH·09120069811926·Anterior Clavicle Plate, 10-Hole, Right

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180513149·Long Tube Variable Drill Guide

    LUXATEMP ULTRA /STAR

    FDA 510(k)
    FDA Class 2 ·Dental

    OXOID PBP2 1 LATEX AGGLUTINATION TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    JRNY BCS PAT RESRF RD 35 MM STD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

    INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 2, 2019

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 16, 2016

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 8, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 23, 2015

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 10, 2013

    FLO-THRU INTRALUMINAL SHUNTS

    FDA Adverse Event
    Malfunction ·SYNOVIS SURGICAL INNOVATIONS·Product code DXC·September 23, 2014

    STRATA VALVE/SHUNT

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·May 25, 2011

    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

    JOURNEY POLY TIBIAL INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 11, 2025