BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025057·G85 Mini Incubator

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·April 24, 2020

    SEVIIN REVERSE SHOULDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OCULIGHT SL/SLX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GLIDEWELL HT IMPLANT Ø3.5 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 28, 2025

    GLIDEWELL HT IMPLANT Ø3.5 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 28, 2025

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 4, 2008

    OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO·Product code DTZ·August 11, 2011

    QUADRA ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    G85 MINI INCUBATOR WITH

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code PUB·May 24, 2023

    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·March 29, 2017

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024