BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    TUTODENT DENTAL MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BRAIN COIL, MODEL 9800GE-64

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·January 14, 2019

    MERSILENE POLYESTER FIBER MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·April 23, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·April 29, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. 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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024