BEUDAMED
    22 results · 27ms · Sources: EU EUDAMED, US FDA

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    ENDOCHOICE WATER BOTTLE CAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111065484·DEAVER SCISS DEL CVD S/B 5 1/2

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916120382·Hyper ZEUS®-L 14 x 21 x 55mm, 14 Degree

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916134266·ZEUS®-L, Lateral Lumber Interbody Fusion Device...

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916141011·ZEUS® LLIF 14mm x 21mm x 55mm x 14° TRIAL

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916140960·ZEUS® LLIF 14mm x 21mm x 55mm x 07° TRIAL

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916141059·ZEUS® LLIF 14mm x 21mm x 55mm x 21° TRIAL

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916134303·ZEUS®-L, Lateral Lumber Interbody Fusion Device...

    PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MR RADIATION ONCOLOGY OPTIONS

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 13, 2022

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 1, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 27, 2020

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·September 11, 2019

    GOLD PROBE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·June 3, 2013

    PENUMBRA CATHETER 025 (PX400 MICROCATHETER)

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code DQY·May 26, 2011

    PINN CAN BONE SCREW 6.5MMX25MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·October 4, 2014

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025