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

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    EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters

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

    BIOFLEX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 13, 2014

    ETS FLEX ARTICNG LNR CUTR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 13, 2012

    ON-Q PAIN PUMP

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·September 8, 2010

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024