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

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    Hudson RCI Triflo II Incentive Deep Breathing Exerciser

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180120990·5 MM DIA., 33 CM INSULATED KNIFE ELECTRODE WITH...

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996134576·LATERAL,10DEG ANGLED CONVEX

    BALLARD™

    FDA UDI
    SUNMED, LLC·10889483623411·BALLARD™ SUCTION SYSTEM FOR ADULTS, T-Piece, En...

    Ballard* Closed Suction System for Adults

    FDA UDI
    Avanos Medical, Inc.·00609038983073·BALLARD* Closed Suction Catheter, T-Piece, WET ...

    H-TRONPLUS

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·February 10, 2006

    EMBLEM¿ MRI S-ICD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·November 29, 2022

    EAV COMBI-2

    FDA 510(k)
    FDA Class 2 ·Neurology

    Galapogos

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNKNOWN

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HSH·October 31, 2008

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 23, 2011

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 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: N/A

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

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 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: N/A

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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021