BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Juliet Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813834·GENUMEDI PRO SILVER SIZE III

    ZenFlex

    FDA UDI
    Kerr Corporation·00195062029585·Rotary Files

    Origin Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215051778·

    Origin Lateral Offset Collared Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215017781·

    Paxeon Origin

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570205004·

    TINA-QUANT ALBUMIN GEN 2

    FDA 510(k)
    FDA Class 2 ·Immunology

    OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STRATUS Stem - High Offset - Collared - Size 12

    FDA UDI
    AMPLITUDE SAS·03701089504928·

    Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·July 24, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    LAG SCREWDRIVER GAMMA3 380X110MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·June 21, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 30, 2008

    MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·April 28, 2023

    MOZECTM NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·October 21, 2023

    SOEHENDRA STENT RETRIEVER

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 26, 2017

    INNOVA IGS 530

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019

    K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

    FDA Enforcement
    Class II ·Ongoing·Kamiya Biomedical Company, LLC·November 30, 2022

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021