BEUDAMED
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    CARDIOSENTRY EVENT MONITOR, MODEL 8470-01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00163041·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054656·Strip Crown Forms

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00160341·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001634·artVeneer life upper anteriors, BOL, BL4

    Scanlan® SURG-I-BAND® color coding

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001310·Scanlan® SURG-I-BAND® color coding - Narrow, Gr...

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 21, 2022

    MODEL APS ALTERNANS PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROD TO ROD CROSS BRACES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·February 18, 2018

    2.8MM PERCUTANEOUS DRILL BIT F/LCP PL QC/200MM/100MM CALIB

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·February 8, 2021

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·March 13, 2013

    HEMOCCULT ICT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC·Product code KHE·February 25, 2011

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 7, 2008

    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.

    FDA Enforcement
    Class II ·Terminated·Physio Control, Inc.·July 31, 2013

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    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