BEUDAMED
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    Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    Conventional Lead Apron .5mm Xtra Large 25 X 40

    FDA UDI
    Flow X Ray Corporation·00843696123611·Conventional Lead Apron .5mm Xtra Large 25 X 40...

    10PW - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020129·10PW - General Purpose

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112519·BARRON VACUUM TREPHINE 8.0MM

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 16, 2022

    NDO SURGICAL SURGICAL OVERTUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560

    FDA 510(k)
    FDA Class 2 ·Immunology

    NORIAN REINFORCED FAST SET PUTTY/3CC

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code GXP·May 19, 2015

    OPTISENSE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM INC.·Product code MDS·July 2, 2013

    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

    FDA Recall
    Open, Classified ·Thomas Scientific·Product code LIO·July 14, 2020

    SFX SYM PDS+ VIO 18IN 1 S/A CT-1

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·December 14, 2018

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

    FDA Enforcement
    Class II ·Ongoing·Thomas Scientific·November 25, 2020

    CNS-6201A

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·January 10, 2019

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)

    FDA Recall
    Terminated ·Johnson & Johnson Surgical Vision Inc·Product code MLZ·September 24, 2018

    Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

    FDA Recall
    Terminated ·Quasar Bio-Tech, Inc.·Product code OHS·June 29, 2018