BEUDAMED
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    MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Bur PM2-95 80K matchstick Ø1.8mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711003360011·

    Bur PM2-95 80K Mstick Ø1.8 St

    FDA UDI
    Bien-Air Surgery SA·17630055503074·

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037309186·HUMERIS SPACER CUP +3mm GLENOSPHERE Ø36C

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450174180·

    RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVANTAGE WINDOWS CT/PET FUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    microTargeting™ WayPoint™ Inserter Kit

    FDA UDI
    FHC, INC.·00873263003367·microTargeting WayPoint Inserter Kit, 130mm, fo...

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    PINN CAN BONE SCREW 6.5MMX15MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·May 8, 2013

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·September 18, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2011

    DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244

    FDA Adverse Event
    Injury ·FIAB SPA·Product code GEI·October 12, 2023

    ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 10, 2021

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020