BEUDAMED
    16 results · 31ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO STRYKER SPINE OASYS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCITON IMAGE HAIR REMOVAL LASER

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

    SMART GLOVE STERILE NITRILE EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EEA 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·June 1, 2015

    EEA31

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 31, 2015

    PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*

    FDA Adverse Event
    Injury ·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GDW·November 4, 2015

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 17, 2013

    IMMULITE 2500 STAT TROPONIN I

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 18, 2008

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·April 19, 2011

    DST SERIES ORVIL AUTOMATIC 25MM DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·April 25, 2016

    CALCIUM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020

    EEA 31MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·December 11, 2015

    MOZAIK

    FDA Adverse Event
    Injury ·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021

    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 20, 2012

    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