BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    ACCUCLOT CONTROL I, MODEL A4089

    FDA 510(k)
    FDA Class 2 ·Hematology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964022980·The ENDO CARRY-ON Procedure Kit contains all of...

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134

    INTRODUCER SHEATH

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

    MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    Zimmer, Inc.·00889024066472·

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MRW·June 4, 2009

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code HWC·June 4, 2009

    UCSS

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2016

    BTB TIGHTROPE

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HTY·March 14, 2013

    N/A

    FDA Adverse Event
    Malfunction ·ASCENT·Product code NLH·March 1, 2011

    STERRAD 100S STERILIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 27, 2008

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·January 3, 2011

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 23, 2020

    GUIDE, SURGICAL, INSTRUMENT

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code FZX·September 25, 2019

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024