BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    FORTEX PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Conmed Corporation·10845854003350·MICRO ROUND BUR, SHORT, CARBIDE, 2MM, QTY 5

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776363321·Oral Exodontia Curette, #9

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027933·

    SYRINGE 10ML LL S/C 200

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 24, 2020

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·December 27, 2022

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197193146·Tebbet Breast Retractor 90x24m...

    SYRINGE 10ML LL S/C 200

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 24, 2020

    NPAC MULTI-USE THERMOMETER, MODEL TD400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLUROPERM 60-OK, PARAGON HDS-OK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 13, 2023

    FORTIFY VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·May 6, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 5, 2008

    UNK HAKIM PROGRAMMABLE VALVE

    FDA Adverse Event
    Injury ·Product code JXG·November 14, 2017

    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·September 3, 2014

    Inserter for Titanium Elastic Nails (TEN), orthopedic device

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 21, 2015

    Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 18, 2015