BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    MSI I2010 DUAL PLACE HYPERBARIC CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743670·ACHIMED ACHILLES SUPP SILVER IV

    Safco Gates Glidden Drills

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310222146·Safco Gates Glidden drills, #06, 28mm, 6/box

    MedGyn Uterine Curette

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803022214·14mm rigid straight curette

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113522·PS-C Insert, Size 2 x 14mm

    SINUSCOPE AND BACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CRYOPEN AND ACCESSORIES

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

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Injury ·MATORHTO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    BD NEOFLON¿ PRO IV CANNULA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·January 12, 2023

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·February 28, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 19, 2014

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·March 26, 2008

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 20, 2024

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

    RANGER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ONU·December 21, 2022

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013