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

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    PILOT POSTERIOR LUMBAR PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 14, 2023

    CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD DIRECTIGEN FLU A+B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code MNI·April 16, 2013

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·March 17, 2011

    PEAK FX PLATE 3 HOLE NS

    FDA Adverse Event
    Injury ·DEPUY ACE S.A. 'R.L.·Product code KTT·June 13, 2008

    PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 2, 2019

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015