BEUDAMED
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    PNS MAGNETIC STIMULATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964020467·Endo Carry-On Procedure Kit

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450207765·

    ROSETTA-LT/ROSETTA-RX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENOJ IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DA VINCI ROBOTICS SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003

    SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·March 13, 2013

    ASR UNI FEMORAL IMPL SIZE 41

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

    IMPLANTIUM

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

    DETACHABLE SLIDE HAMMER 580 GRAMS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZY·April 24, 2017

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

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

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