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

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    TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973578·

    TALUS OF VILEX (TOV)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNSPECIFIED PRIMARY PLUM SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code OYC·October 3, 2014

    LIFEPAK EXPRESS(R) DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·June 3, 2013

    UNKNOWN DEPUY ACE 6.5 MM SCREWS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HWC·June 22, 2011

    O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024

    PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014