BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    Medaica M1 Telehealth Stethoscope

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ponto

    FDA UDI
    Oticon Medical AB·05712149026548·PONTO 5 SUPERPOWER, DBL

    iTero Lumina – PC cfg

    FDA UDI
    Align Technology, Inc.·00816063023289·Scanning unit Service RMA,Performance PC conf, ...

    PERMATAPE

    FDA UDI
    Medos International Sàrl·10886705027866·PERMATAPE SUTURE White/Blue Braided Flat Suture...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113998·HYDRO-DISSECT CANNULA VERTICAL 27GA

    TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WU'S 3-WHEELED NEO SCOOTER, WT-M4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 13, 2012

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 26, 2012

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 26, 2012

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 27, 2019

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 12, 2013

    Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 Product Usage: Tracheal tube/airway management

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTR·May 24, 2019

    Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 Product Usage: Tracheal tube/airway management

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·June 26, 2019

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018