BEUDAMED
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    INTRALASE 600C LASER KERATOME

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

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776123734·Yasargil Bipolar Forcep

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

    CHAD THERAPEUTICS OXYMATIC MODEL 401

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    VUELOCK PLATE, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·March 13, 2013

    14/16 LG TAPER M HEAD 36MM+5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·February 16, 2011

    IMPLANTIUM

    FDA Adverse Event
    Other ·DENTIUM CO., LTD.·Product code DZE·February 22, 2008

    Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

    FDA Recall
    Terminated ·Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom·Product code CAH·June 7, 2005

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024