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

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    Contact Lens Case, Model: A-1, B-1

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331155116·lanes tissue forceps, cross-serrated, 1x2 teeth...

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575203840·Hip Prosthesis Stem,Size 01

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575203864·Hip Prosthesis Stem,Size 03

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320691·Hip Prosthesis Stem,Size 0

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575203857·Hip Prosthesis Stem,Size 02

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575203901·Hip Prosthesis Stem,Size 06

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575203871·Hip Prosthesis Stem,Size 04

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575203895·Hip Prosthesis Stem,Size 05

    CANDELA-INOLASE SERENITY PRO PSF SYSTEM

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

    NEXGEN EXPANDABLE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXTRACTOR HANDLE OMEGA2 HANSSON TWIN HOOK

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·June 1, 2011

    TBD

    FDA Adverse Event
    Malfunction ·Product code KOD·April 5, 2018

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 23, 2011

    UNKNOWN DEPUY ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 17, 2013

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 19, 2008

    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 1, 2023

    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