BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    V.A.C.ULTA Negative Pressure Wound Therapy System

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

    OTI CERAMIC FEMORAL HEAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIU·October 23, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023

    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