BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441039·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441015·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441046·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441022·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441008·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033440995·

    MODIFICATION TO PROFILE -II

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 2, 2024

    0009613348-2024-012776

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 24, 2024

    GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 26, 2022

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 15, 2006

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 20, 2013

    ATN LAG SCREW 100MM STERILE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSB·February 24, 2011

    ACCU-CHEK AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·March 12, 2008

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019