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

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    CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO

    FDA 510(k)
    FDA Class 2 ·Dental

    SEMIAL 5°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844000779·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...

    SUGAR CHEX ONE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    THREADED CEMENT RESTRICTOR (CR) TITANIUM

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

    UNKNOWN COPELAND SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·April 14, 2017

    COPELAND SH HUM SZ4 STND PLUS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·June 8, 2016

    UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·October 21, 2016

    UNKNOWN COPELAND RESURFACING SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·May 16, 2017

    UNKNOWN COPELAND SHOULDER GLENOID COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·July 5, 2017

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 10, 2013

    TRANSPORT SERIES

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 4, 2011

    SEPARATOR 032

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·May 21, 2008

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 11, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022