BEUDAMED
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    ICRCO 3600M

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCOTT'S SELECT K-FILES 6/pk 25mm # 10

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811225101·ENDODONTIC K-FILES (6/pack) Length: 25mm, Size:...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776172152·BROWN-ADSON NEEDLE FCP T . TC

    Fibula Plate 3.5mm

    FDA UDI
    I.T.S. GmbH·09120047298329·Fibula Plate 3.5mm, 10-Hole, Right

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113706·PS-C Insert, Size 5 x 10mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1220100·Breaker, Extended Tab

    FONIX, MODEL 7000

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DIMENSIONS HB1C KIT, MODEL DF105A

    FDA 510(k)
    FDA Class 2 ·Hematology

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·May 15, 2013

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 22, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020

    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

    I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    OPT SLEEVE 12X100 STABILITY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 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

    GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 28, 2019

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025