BEUDAMED
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    SYNELISA SM ABS/RNP-SM ABS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Nu-Edge Cobalt Chromium Brackets

    FDA UDI
    TP ORTHODONTICS INC·00192029045466·UL LAT

    PLIF Allograft

    FDA UDI
    Seaspine Orthopedics Corporation·10889981087685·Offset Curette, Left

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515237155·Cook Osteotome, 5mm cut edge, 6 1/4", cvd, rt g...

    MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNSPECIFIED SAFESET TRANSPAC SETS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

    16F X 24CM SPLIT CATH III

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code MSD·November 18, 2010

    TI 12-POINT NUT-11MM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·January 25, 2013

    LARGE HEXAGONAL SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HXX·July 11, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 14, 2019

    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014