BEUDAMED
    22 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

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

    SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPRESSYN STAPLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLAT TITANIUM PECTUS BAR 10.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 12

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·CMEDTRONIC MINIMED·Product code OYC·October 13, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·July 12, 2011

    PFC*SIGMA C/S STTB IN20MM/SZ 4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC·Product code JWH·July 9, 2013

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    CEFALY

    FDA Adverse Event
    Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

    CEFALY

    FDA Adverse Event
    Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

    FLAT TITANIUM PECTUS BAR 12.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    PRECISION FLOW PLUS

    FDA Adverse Event
    Malfunction ·VAPOTHERM·Product code QAV·February 28, 2022