BEUDAMED
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    MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES

    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

    SUPER REVO SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR

    FDA 510(k)
    FDA Class 2 ·Immunology

    OT BASIC METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 8, 2010

    OT BASIC METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 6, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·March 27, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 14, 2011

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008

    OT BASIC ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 6, 2011

    OT BASIC METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 4, 2011

    OT BASIC ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 12, 2011

    OT BASIC METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 20, 2011

    OT PROFILE METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 2, 2012

    OT BASIC ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 16, 2010

    OT PROFILE METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 30, 2010

    OT BASIC METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 14, 2011

    OT PROFILE METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 22, 2011

    OT BASIC METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 7, 2011