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

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    ACCESS DIGOXIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ALVINE TOTAL ANKLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CENTAURI/PEGASUS

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

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 22, 2013

    SENSIA SR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·December 14, 2010

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014

    LAPRO-CLIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GCJ·June 4, 2025

    TPRLC 133 MP TYPE1 PPS HO 10.0 M T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019

    TPRLC 133 MP TYPE1 PPS HO 12.0 M T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019

    TLOC 133 MP SP T1 PPS HO 8X101

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019

    TPRLC 133 MP TYPE1 PPS SO 17.0 1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019

    TPRLC 133 T1 PPS HO 17X154MM 4MM T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019

    BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 2, 2013

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024