BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    NEXA COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037312490·145° EXTRAMEDULLARIS DELTO PECTORAL CUTTING GUIDE

    TMA - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989026399·ARCH ALXLOOP TMA 17X25 S/U 36MM PK/5

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600010·Tray Insert, Level 1

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0600010·Tray Insert 1, Ocata

    ONESTEP

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 9, 2024

    VIRIDIS DERMA LASER

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

    SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HIRES 90K IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·April 11, 2013

    IMPULSE GUIDE CATHETERS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DQO·June 11, 2008

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 15, 2011

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013