BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    MODULEAF

    FDA 510(k)
    FDA Class 2 ·Radiology

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037308417·TRIAL HUMERAL CUP MOBILITY Ø36+9

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037302835·HUMERAL CUP MOBILITY PE/TA6V Ø36/+9

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106090·Trial, 26 x 9mm, 8 Degree, Tapered, Straight

    LYNX

    FDA UDI
    HNM TOTAL RECON LLC·00841742112343·LYNX Humeral Locking Plate, Dorso Lat Anatomica...

    N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARDTEL, MODEL NT-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    BOOMERANG PEEK FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011

    NUPRO PROPHY PASTE

    FDA Adverse Event
    Injury ·DENTSPLY PROFESSIONAL·Product code EJR·March 21, 2013

    TOTALCARE SPO2RT

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 22, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·April 16, 2008

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    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