BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    HemoCue® Hb 301 Microcuvettes

    FDA UDI
    Hemocue AB·17311091118094·HemoCue Hb 301 Microcuvettes 4x50 vial

    Bernafon

    FDA UDI
    Bernafon AG·05711584005613·CT7 M, VC PS SF GB CANTEO 7

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G2231118090·Bonn Suture Forceps 1x2 teeth, TW 0.12mm OL 70m...

    Flexitron

    FDA UDI
    Nucletron B.V.·08717213026551·Flexitron Transfer Tube for Metal Needles (4)

    FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WIRELESS MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260901·

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 7, 2013

    KIMBERLY CLARK-BALLARD MEDICAL R-2 PAD ADAPTOR

    FDA Adverse Event
    Malfunction ·CON MED·Product code MKJ·August 13, 2008

    PAIN CARE 3000

    FDA Adverse Event
    Injury ·BREG, INC.·Product code FRN·May 25, 2011

    PANTHER FUSION ADV/HMPV/RV ASSAY

    FDA Adverse Event
    Injury ·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021

    PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021

    UNK - PLATES: SPINE

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·March 27, 2020

    AMISTEM-P COLLARED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 25, 2025

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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

    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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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