BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    VERTECEM II CEMENT KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

    MAS WITH OR WITHOUT SYRINGE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 25, 2024

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 31, 2023

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 21, 2013

    TRIO TRAUMA SCREW DIA 5.5 X 45 MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code MNI·September 26, 2014

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 9, 2011

    INSERTER FOR TI ELASTIC NAILS

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·September 11, 2014

    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

    Inserter for Titanium Elastic Nails (TEN), orthopedic device

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

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024