BEUDAMED
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    MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM

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

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704508109·

    Clean-Bor Tube 1-3/8" x 47"

    FDA UDI
    Vacumed·00850644007756·Clean-Bor Tube

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450189658·

    Clean-Bor Tube 1-3/8" x 47"

    FDA UDI
    Vacumed·00850644007763·Clean-Bor Tube

    CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)

    FDA 510(k)
    FDA Class 2 ·Dental

    ENHANCED POLYETHYLENE KNEE PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLAKE DRAIN

    FDA Adverse Event
    Injury ·ETHICON, INC·Product code KOG·April 19, 2011

    ONE TOUCH BASIC

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·April 30, 2002

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 11, 2020

    DELTAFILL18 8MM X 35CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 25, 2022

    DREAMSTATION

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 23, 2025

    FORTIFY DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·September 17, 2014

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 24, 2011

    BLAKE DRAIN

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GBX·March 24, 2011

    BIO-MEDICUS

    FDA Adverse Event
    Injury ·PERFUSION SYSTEMS·Product code DWF·November 1, 2017

    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

    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