BEUDAMED
    29 results · 8ms · Sources: EU EUDAMED, US FDA

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    10 GAUGE DRILL, CODE INTVM-DRL

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    SMR allen wrench 5 mm, product code 9013.50.210

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 7, 2016

    Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120

    FDA Enforcement
    Class II ·Terminated·RanD S.r.l.·July 21, 2021

    10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.

    FDA Enforcement
    Class II ·Terminated·RanD S.r.l.·July 21, 2021

    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·January 3, 2018

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·December 20, 2023

    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·June 13, 2018

    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·March 22, 2023