BEUDAMED
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    EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    HHM

    FDA UDI
    Oticon A/S·05707131351845·G300 SC, BTE PP 13 2.4G 105 C090 TAR HHM

    METAPHYSARY BROACH ESOP LEFT SIZE 12,5

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489017582·

    7450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136022567·7450XS FACE MASK-HDGR& 2700 MA

    NA

    FDA UDI
    Synthes GmbH·10886982142696·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2017580·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M9307201758010·Long Cobb Elevator 5/8", 9" Handle

    Accuvue+

    FDA 510(k)
    FDA Class 2 ·Radiology

    DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·July 12, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 4, 2019

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·March 4, 2019

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·March 4, 2019

    GE OEC 6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 5, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 26, 2013

    HAMILTON-C6

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025