BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    APEX SPECIMEN BAG

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Couture Essence

    FDA UDI
    Carolon Company·00078301930333·

    Mini Sprint ®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR79303131·Mini Sprint II Bracket FACE Evolution II System...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9303130·

    Mini Sprint ®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR79303130051·Mini Sprint II Bracket FACE Evolution II System...

    Mini Sprint ®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR79303131001·Mini Sprint II Bracket FACE Evolution II System...

    Mini Sprint ®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR79303130101·Mini Sprint II Bracket FACE Evolution II System...

    QUANTUM Patient Specific Instrumentation (PSI) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIEMENS INFINITY SC 6002XL MODIFICATIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·January 23, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 24, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 11, 2014

    PFNA-II BLADE L90 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HSB·October 27, 2016

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    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