BEUDAMED
    16 results · 41ms · Sources: EU EUDAMED, US FDA

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    Oral-B Dry Mouth Oral Rinse

    FDA 510(k)
    FDA Unclassified ·Unknown

    36M - Navajo Tribal Utility Authority

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority

    10PW - Penn Power & Light

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012179·10PW - Penn Power & Light

    Navajo Tribal Utility Authority - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal

    ORION II (HEAVY DUTY 350 LBS AND 500 LBS)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TRIFLANGE ACETABULAR CUP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HAHN TAPERED IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 19, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 3, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    VALIANT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·March 1, 2013

    TALENT

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 14, 2014

    ONYX AVM

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code MFE·April 28, 2015

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021