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

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    CRYOMATIC

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040111823·LINGUAL RETAINER LIGHT CURE 30MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000772·2.4mm x 12mm Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694008273·2.4mm x 12mm Lag Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035095·2.4 x 12mm Lag Screw, Sterile

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2023

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694066884·HPS 2.4 x 12mm Lag Screw Sterile Qty 5

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694062848·2.4 x 12mm Screw Sterile Qty 5

    RE-USEABLE MICROSTAAR INJECTOR, MSI-S

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 5, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·April 12, 2011

    ANGIODYNAMICS / SMART PORT

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code LJT·August 21, 2017

    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

    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