BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606301·Mini-Mono-Brackets Roth 'S2' .018" 9° 1000 Brac...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"

    Truliant CC

    FDA UDI
    Exactech, Inc.·10885862625984·TRULIANT CC MODULAR FEMORAL BOX TRIAL SIZE 3 LEFT

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862284792·LOGIC CC FEM BOX TRIAL SIZE 3 LEFT

    MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Y-TZP POWDER AND PROCERA ALLZIRKON

    FDA 510(k)
    FDA Class 2 ·Dental

    BD¿ STERILE INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 11, 2018

    Widex

    FDA UDI
    Widex A/S·05706069679106·Widex EVOKE E-CIC-M TR (Dark brown ) 330

    Widex

    FDA UDI
    Widex A/S·05706069679090·Widex EVOKE E-CIC-M TR (Clay brown ) 330

    Widex

    FDA UDI
    Widex A/S·05706069679083·Widex EVOKE E-CIC-M TR (Light beige ) 330

    BD STERILE INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 16, 2019

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 22, 2024

    BD PLASTIPAK¿ SYRINGE LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 23, 2019

    ULTRASONIC DISSECTOR QTY OF 6

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code LFL·March 27, 2013

    SHILEY FEN LPC

    FDA Adverse Event
    Injury ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code BTO·June 13, 2008

    TOTAL ASR FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 6, 2011

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022