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

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    AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    Smith & Nephew, Inc.·23596010091141·BONE TUNNEL PLUG NON-CANNULATED, ...

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508688·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508671·

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795134301·3.5mm x 62mm, Threaded Peg, Ti

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508664·

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·May 4, 2015

    LUMEND PERCUTANEOUS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALPHA DX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CORAIL2 STD SIZE 12

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWA·March 30, 2020

    AVIATOR ASSY TWO LEVEL PLATE SIZE 28

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016

    TI PSPC MATRIXMANDIBLE 7X23 H ANGLE RECON PL/LEFT/2.0MM THK

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code JEY·March 20, 2013

    OXIMAX N-560 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code DQA·February 2, 2011

    INSYNC ICD

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·March 10, 2008

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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