BEUDAMED
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    SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040095553·Prophy Angle Seal-Tite

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126521·

    Comfort Short™ cannula

    FDA UDI
    Unomedical A/S·05705244003132·Single use infusion cannula for subcutaneous in...

    neria™soft cannula

    FDA UDI
    Unomedical A/S·05705244001534·Single use infusion cannula for subcutaneous in...

    TRUSTEEL

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 8, 2025

    TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION

    FDA 510(k)
    FDA Class 2 ·Dental

    BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 15, 2020

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 18, 2025

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013

    DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·February 28, 2011

    ACCU-CHEK COMPACT PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·February 8, 2008

    bk5000 Ultrasound System w/battery; Model No. 2300-61; 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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

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

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