BEUDAMED
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    ILLUMINATING SINUS SEEKER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642108569·Modular Spacer, 26 mm (W) x 26 mm (L) x 15 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

    Avalign

    FDA UDI
    Avalign Technologies, Inc.·00190776021542·Square nut for 1000-918-009

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 12, 2022

    THROMBOMAX-HS WITH CALCIUM, MODEL T6540

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIC INSTRUMENT PROCESSING SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

    WAVEWRITER ALPHA? 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 2, 2026

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CAW·May 13, 2013

    TRUERESULT

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

    LINK(R) MP(TM) FIXATION SCREW

    FDA Adverse Event
    Injury ·WALDEMAR LINK GMBH & CO. KG·Product code JDI·June 1, 2011

    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

    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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024