BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    Osseointegrated Fixtures

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

    WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE

    FDA 510(k)
    FDA Class 2 ·Radiology

    STRYKER URETERAL ILLUMINATION SYSTEM IV

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    P.F.C.* FLUT TIB ROD 75X22MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code JWH·June 11, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 14, 2011

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR REDWOOD CITY·Product code FGE·September 15, 2008

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    TFNA FEM NAIL Ø11 R 130° L360 TIMO15

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·February 23, 2023

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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