BEUDAMED
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    Luxisse+

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490542302·SCRAPER 9150056 PULL

    Oticon

    FDA UDI
    Oticon A/S·05707131284587·NERA2 PRO, RITE 312 WL CBE

    Trial Cage 15deg 14L

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215066659·

    MEDCOM RT-VIEWER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODEL 2500A PALMSAT PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 7, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 21, 2013

    COLLEAGUE PRE 1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Ceterix Orthopedics, Inc.·November 18, 2015

    Philips DuraDiagnost stationary X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·September 7, 2016

    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012