BEUDAMED
    17 results · 36ms · Sources: EU EUDAMED, US FDA

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    WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V

    Bernafon

    FDA UDI
    Bernafon AG·05711584058992·SU9 P, VC PS MSIL/MAC SUITE 9

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1622250·16mm H x 22mm W x 25mm L x 0 degrees XLIF

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122285·KWire .062x9" (1.6x225mm)

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X162225120·16mm H x 22mm W x 25mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X16222580·16mm H x 22mm W x 25mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L162225120·16mm H x 22mm W x 25mm L XLIF Trial 12 degree L...

    HALO COAGULATION CATHETER

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

    ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 7, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

    COMPAX 40E

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code IZZ·September 16, 2008

    CP5 FLOW MODULE

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 2024

    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

    FDA Recall
    Terminated ·Neomed Inc·Product code KNT·October 24, 2018

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024