BEUDAMED
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    Medical Endoscope Image Processing System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776379773·Small Wishbone Arm - set

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707012·Rubin Dorsal Osteotome 7" (17.5cm), 8mm wide

    CADD

    FDA UDI
    ICU MEDICAL, INC.·15019517126884·

    ACCULIF CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TREMOROMETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORPORATION·Product code MVK·March 10, 2026

    OMNI-FLEX SUPPORT ARM

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code FFO·August 27, 2019

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·June 26, 2024

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM LENG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·October 21, 2008

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code NKB·August 8, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code GXI·January 19, 2007

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·November 27, 2024

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024

    CADD SOLIS AC ADAPTER

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·October 4, 2022

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014