BEUDAMED
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    EVIS EXERA III VIDEO SYSTEM

    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

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970379·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970423·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970393·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970416·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970409·

    DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE

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

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·November 22, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 6, 2019

    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY

    FDA Adverse Event
    Injury ·WILLIAM COOK AUSTRALIA·Product code MIH·May 15, 2013

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    FDA Adverse Event
    Other ·CARIDIANBCT·Product code LKN·June 1, 2011

    CURLIN

    FDA Adverse Event
    Malfunction ·CURLIN MEDICAL, INC.·Product code MEA·August 13, 2008

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·June 27, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·October 17, 2019

    HISTOACRYL BLUE TISSUE ADHESIVE

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·January 23, 2020