BEUDAMED
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    ALADDIN HW3.0

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694018951·2.7mm Cannulated Drill, Manual

    The Block

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215046378·

    HEARTWAY POWER CHAIR, P23

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC SINGAPORE OPERATIONS·Product code NVN·June 10, 2013

    NITRO I.V. DC INF. SET W/LB TBG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017

    GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 3 LM/RL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·May 24, 2017

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015