BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    Surgical Drills

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777679·LUMBAMED BASIC DORSAL STAYS M SILVER V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777624·LUMBAMED BASIC DORSAL STAYS WM SILVER V

    Fungal Serology

    FDA UDI
    MICROBIOLOGICS INC.·10634853000039·Blastomyces dermatitidis Antiserum, 1mL ID/EXO

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034487·VISIDISK, PROFILE ZERO

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306837036·AK Thyroidectomy Blade 35mm x 125mm

    BALANCE MICROPLASTY BROACH

    FDA UDI
    Biomet Orthopedics, LLC·00880304459342·

    SERRALENE, MODEL CATALOG NO 1S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 8, 2022

    ONE TOUCH II

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·January 10, 2002

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 17, 2020

    EZ-IO 25MM NEEDLE SET + STABILIZER(B

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FMI·August 11, 2020

    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

    FDA Recall
    Terminated ·Gibson Laboratories LLC·Product code LSI·January 20, 2017

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013

    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

    FDA Enforcement
    Class II ·Terminated·Gibson Laboratories LLC·February 21, 2018

    TRUE METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·September 18, 2020

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024