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

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    MODIFIED SEISMOCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Barricade Coil System

    FDA UDI
    BALT USA LLC·00818053021299·Barricade Coil System (BCS) is intended for the...

    Biopsy Handy

    FDA UDI
    SOMATEX Medical Technologies GmbH·04250195601896·

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746096952·DB BKT MASTER IBD LOWER ANT 022 T-1 A=0 R=0

    Intact

    FDA UDI
    MEDTRONIC, INC.·20643169863075·WAND 900-130 5PK 30MM DISPOSABLE

    MSI

    FDA UDI
    Modern Surgical Instruments LLC·00810130201884·Long Cobb Elevator 15" Overall With 9" Handle, ...

    CONLIN MOLAR BAND

    FDA UDI
    Ortho Arch Company Inc·D90990013010·MOLAR BAND CONLIN RX UPPER RIGHT 43 1/2

    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

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DXT·May 16, 2008

    TCP

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420169532·

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707050757·.022/.045 UL6 CV OCBT -14T 0A 14O

    XBraid TT

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00840277401212·Suture Tape

    ORTHOMED

    FDA UDI
    ORTHO-MED, INC.·B8039001300·COBB ELEVATOR 15" OVERALL W/9" HANDLE 1"

    HARDYDISK, NALIDIXIC ACID, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ATMOS S041 WOUND

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

    Truliant

    FDA UDI
    Exactech, Inc.·10885862604903·

    SINGLE EXTENSION

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

    FUSIONBOLT Ø6.5 L110 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·January 7, 2013

    EYE SURGERY STRETCHER

    FDA Adverse Event
    Injury ·STRYKER CORP, MEDICAL DIV.·Product code FPO·November 9, 2010

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021