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

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    INSTRUMENTS FOR NEUROLOGICAL SURGERY

    FDA 510(k)
    FDA Class 2 ·Neurology

    PERITONEAL SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929013130·PERITONEAL SCISSORS STRAIGHT SINGLE-ACTION JAW

    HALO MOLAR BAND

    FDA UDI
    Ortho Arch Company Inc·D90990131314·L6R HALO MOLAR BAND .022 SGL NON-CV -20T BT

    SYSMEX MODEL XT-4000I

    FDA 510(k)
    FDA Class 2 ·Hematology

    AIRDENT II CS

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 23, 2021

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 4, 2021

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·January 8, 2013

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 17, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021