BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAHA 3 POWER SOUND PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ORTHOPEDIATRICS 3.5MM, 80 DEGREE, 4-HOLE, 5 DEGREE FLARE, PLATE

    FDA Adverse Event
    Injury ·ORTHOPEDIATRICS, INC·Product code HRS·June 29, 2018

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·October 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 13, 2011

    ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

    FDA Adverse Event
    Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018

    ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

    FDA Adverse Event
    Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018

    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017

    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020