BEUDAMED
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    URETHROTOME 8667.XXX AND 8670.XXX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Preclean Kit

    FDA UDI
    MEDIVATORS INC.·40677964007901·Preclean Plus Kit includes Brush, DEFENDO Air W...

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741183102·Catheter Placement Kit

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00009051·

    Tooth Tone

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730015518·SS Coated Lower 020 10 archwires per pack

    IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OLYMPUS SONOSURG TROCAR XT3900 SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    PORTEX BLUE LINE ULTRA SUCTIONAID CUFFED TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL CZECH REPUBLIC A. S·Product code BTO·December 31, 2024

    DIALYZER

    FDA Adverse Event
    Malfunction ·CGH MEDICAL, INC.·Product code FJI·March 1, 1994

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code BTO·July 11, 2024

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·June 5, 2024

    PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL CZECH REPUBLIC A. S·Product code BTO·May 13, 2024

    PORTEX BLU-SELECT SUCTIONAID TRACHEOSTOMY TUBE, CUFFED

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL CZECH REPUBLIC A. S·Product code BTO·March 13, 2024

    DIALYZER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORP.·Product code FJI·March 1, 1994

    ONYX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·December 9, 2020

    ONYX

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·December 9, 2020

    PORTEX TUBES BLUSELECT SUCTIONAID

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·May 21, 2024

    EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 3, 2015

    PORTEX BLUSELECT SUNCTIONAID CUFFED TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL CZECH REPUBLIC A. S·Product code BTO·July 10, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013