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

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    BIO FLOTE(R)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746097027·DB BRACKET MASTER SERIES IBD MAND RIGHT CUSPID ...

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131101·IN-OVATION® C Base Rx 018 U3-3 CS HK

    Mcot Patch

    FDA UDI
    BRAEMAR MANUFACTURING, LLC·B146MCP0·

    MCOT Electrode BTH

    FDA UDI
    BRAEMAR MANUFACTURING, LLC·B146MCP10·

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131611·IN-OVATION® C Roncone 018 U3-3 CS HK

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

    NA

    FDA UDI
    STRYKER CORPORATION·07613327643831·1/4" DRILL WITH KEY

    DS N95 SURGICAL MASKS AND FLAT SURGICAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AXXESS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·May 28, 2014

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·January 7, 2013

    APEX OVER-THE-WIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·November 16, 2010