BEUDAMED
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    EXACTECH EQUINOXE, PLATFORM FRACTURE STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821019090·

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691028·

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691011·

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691035·

    PLAINSENSE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ULTRA-THIN SDS BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 1, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·March 27, 2007

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code DQY·December 28, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·March 5, 2007

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 28, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code DQY·April 12, 2007

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 19, 2014

    UNICEL DXC 800 PRO INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·April 29, 2011

    SMARTXIDE 50 HS

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021