BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032453·Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl B...

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746161421·DB BKT MINI MS UL BIC 018 T=0 A=0 R=0 197 PAD

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·Product code FOZ·July 6, 2021

    SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IPC® STYLUS TRANSNASAL BUR

    FDA Adverse Event
    Death ·MEDTRONIC XOMED INC.·Product code ERL·February 4, 2015

    TENSION FREE VAGINAL TAPE

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

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 25, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·August 25, 2014

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 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

    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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016