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

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    OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190

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

    ArgenZ ST 98x16 ML C3

    FDA UDI
    ARGEN CORPORATION, THE·D818123365·Dental porcelain/ceramic restoration kit

    AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 36cm x 130°

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665023541·

    LEFORTE SYSTEM BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 22, 2024

    SENSITHERM PROBE

    FDA Adverse Event
    Injury ·FIAB S.P.A.·Product code FLL·July 10, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·June 10, 2011

    PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 24, 2016