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

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    ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER

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

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020430·SPIRA®-A Integrated,Trial, 26x34mm, 20° Lordoti...

    SPIRA-C

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPC1020430·Trial 12.5mm x 16mm Lordotic 7°, 7mm

    SPIRA-L

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPL1020430·Trial, Bi-Convex, 20° Lordotic, 18 x 60mm, 10mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165964·MIS Acetabular Reamer, 43mm

    PELVEX HOMETRAINER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VACUETTE EDTA K2 GEL TUBES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971956·

    PAINSMART

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL GROUP·Product code FRN·April 22, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011

    CLINICAL CHEMISTRY AST-ACTIVATED

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code CIF·August 7, 2008

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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