BEUDAMED
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    ACTIVECARE SFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780024613·Integra® Jarit® Vorse Tube Occluding Forceps, 8"

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642108576·Modular Spacer, 26 mm (W) x 26 mm (L) x 17 mm ...

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110152101·MYSTIQUE® MB RT RX 022 U 5-5 CS HK

    SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTODISC 50 TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·January 11, 2007

    AUTODISC 50 TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·March 24, 2006

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 8, 2022

    MRH KNEE FEM XS LFT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 13, 2013

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 11, 2014

    SIMPLEX P - US TOBRA FD 10-PK

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·May 19, 2011

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·LABSTYLE INNOVATIONS LTD·Product code NBW·October 15, 2025

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 22, 2023

    Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025