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

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    Out Of Srl

    Manufacturer
    🇮🇹 Italy

    OUT OF SRL

    FDA registration
    OUT OF SRL·2 products·🇮🇹 Italy

    REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 5, 2023

    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 5, 2023

    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 9, 2015

    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 9, 2015

    PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·January 24, 2024

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SPA·August 9, 2017

    Non Sterile Cut Gauze

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·RAYS S.p.A.·8 devices

    Neuromed Spa

    Importer
    🇮🇹 Italy·9 Manufacturers