BEUDAMED
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    POINT 4 TRANSLUCENT MODIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010090973·13 MM GRAFT SIZING TUBE

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 29, 2026

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507278·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507292·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507285·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507308·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507315·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507261·

    SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS

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

    TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAXTER- CONTINU FLO

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code FPA·April 3, 1998

    TI COLLAR WITH GROOVES

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

    ACTIV POWDER GP CEMENT

    FDA Adverse Event
    Malfunction ·BRASSELER USA·Product code EMA·February 3, 2011

    MAXIMO DR

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

    MINIARC SINGLE INCISION SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code PAH·November 6, 2013

    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 Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017