BEUDAMED
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    SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM

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

    CardioDay

    FDA UDI
    getemed Medizin- und Informationstechnik AG·04250903202520·The CardioDay Holter Analysis Software is desig...

    CardioDay

    FDA UDI
    getemed Medizin- und Informationstechnik AG·04250903202469·The CardioDay Holter Analysis Software is desig...

    CardioDay V 2.5

    FDA UDI
    getemed Medizin- und Informationstechnik AG·04250903200144·The CardioDay V2.5 Holter Analysis Software is ...

    CardioDay V2.5

    FDA UDI
    getemed Medizin- und Informationstechnik AG·04250903202445·The CardioDay V2.5 Holter Analysis Software is ...

    IDI-STREP B ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ARTHROCARE SYSTEM

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

    BD¿ ALCOHOL SWABS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code LKB·July 29, 2022

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 3, 2013

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·September 16, 2014

    PENUMBRA SYSTEM SEPARATOR 054

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·May 3, 2011

    INNOVA 3100-IQ

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM

    FDA Recall
    Terminated ·ACMI CORPORATION·Product code FFK·April 30, 2004

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025