BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    ORBITER II CCI/SPECT ORBITER II CCI/SPECT

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036006532·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776363840·Medial Ramus Retractor

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm

    ENHANCED COMPENSATING FILTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 19, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·March 1, 2011

    CALAXO - UNK

    FDA Adverse Event
    Other ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·March 10, 2008

    VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code MQP·February 20, 2013

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·March 11, 2024

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code KYF·March 3, 2025

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012

    GORE EXCLUDER AAA ENDOVASCULAR

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012

    Aurora Series, Aurora 7 lighthead; Models: LED7 (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