BEUDAMED
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    nuance UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    BI-METRIC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304254732·

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2

    FDA 510(k)
    FDA Class 2 ·Neurology

    NI

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·December 27, 2018

    27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE

    FDA Adverse Event
    Injury ·BD CARIBE LTD.·Product code BSP·July 27, 2016

    QUADRA H FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 15, 2024

    BD WHITACRE HIGH FLOW PENCIL POINT NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code BSP·July 13, 2015

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2022

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 10, 2014

    PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 15, 2011

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 11, 2013

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 1, 2023

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·September 30, 2025

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 20, 2024

    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·October 3, 2012