BEUDAMED
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    SYNTHES AFS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032534·Baltic Denture System BDLoad Lw6 PLSEbil2DFl C3...

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103173·KATZEN LASIK FLAP SPATULA DOUBLE ENDED

    ADVANCED VASCULAR DYNAMICS

    FDA registration
    ADVANCED VASCULAR DYNAMICS·6 products·🇺🇸 United States

    EUPALAMUS DEFLECTABLE STYLET, MODEL 01545

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXI-SEAL FMS

    FDA Adverse Event
    Other ·CONVATEC·Product code KNT·June 7, 2006

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·April 3, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 29, 2011

    SILICONE INJECTIONS

    FDA Adverse Event
    Injury ·Product code KGM·April 9, 2008

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·CONVATEC INC.·Product code KNT·October 20, 2016

    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

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013