BEUDAMED
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    Biopsy Forceps

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HUMERAL NAIL

    FDA UDI
    Biomet Orthopedics, LLC·00887868004865·

    NIO COLOR 3MP AND MDNC 3120

    FDA 510(k)
    FDA Class 2 ·Radiology

    CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM

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

    MERSILENE TAPE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·November 13, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 17, 2024

    BALL HEADS: MECTACER BIOLOX OPTION 28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2021

    MONTERIS MEDICAL NEUROBLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015

    UNKNOWN_INSTRUMENTS_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code KCY·June 14, 2013

    GEM PREMIER 4000

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code CHL·June 22, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2008

    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

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022