BEUDAMED
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    3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON

    FDA 510(k)
    FDA Class 2 ·General Hospital

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5820302700·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496030270·VENERE 70, SIZE M, BRONZE, GRADUATED COMPRESSIO...

    SCFE Screw

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132114735·4.0mm X 70mm SHORT THREAD CANNULATED SCREW

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981175023·Z-Rod, Dia. 5.5mm, Titanium, 270mm

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197057585·Gross-Maier Swab Forceps straig...

    IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ELECSYS CORTISOL TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067

    FDA 510(k)
    FDA Class 2 ·Radiology

    TriVerse Femoral Component CR

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215100322·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 4, 2025

    MAXI 500

    FDA Adverse Event
    Injury ·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·March 28, 2013

    PD1200 DEFIBRILLATOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·March 21, 2011

    AQUAMANTYS 6.0 BIPOLAR SEALER

    FDA Adverse Event
    Injury ·TISSUELINK MEDICAL, INC.·Product code GEI·April 17, 2008

    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

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024