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

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    PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    PALLA M SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED FEMORAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FEMOSTOP

    FDA Adverse Event
    Malfunction ·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 10, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 26, 2011

    FEMOSTOP

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021