BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    Newclip Patient-matched instrumentation non sterile PSI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221615070·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221615150·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221615000·

    J & J INSTRUMENTS

    FDA UDI
    J & J INSTRUMENTS INC·00817524025712·MAYO SCISSOR 6.75"" CVD

    Symmetry Roux

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482044827·Symmetry® Retractor, Roux, 1 in Wide, 1 1/2 in ...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981215545·No-Profile Interbody, 39mm x 27mm x 16mm, 15 Deg

    4CIS VANE SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAXTER ACCURA SYSTEM, MODEL 5M5660

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

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962113868·ROUX RETRACTOR, 1"X1 1/2"X6", MEDIUM, DOUBLE EN...

    ENDO GIA ROTICULATOR 45-2.0 SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·August 19, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 3, 2014

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 9, 2013

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Enforcement
    Class III ·Ongoing·Alcon Research LLC·November 27, 2024

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code OJK·October 15, 2024