BEUDAMED
    22 results · 27ms · Sources: EU EUDAMED, US FDA

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    ECLIPSE 6.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152863·Endo Carry-on Procedure Kit contains Intercept ...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109750·Zirlux Titanium Abutment 6 mmH compatible with:...

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222669·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222706·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222744·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222683·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222751·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222690·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222713·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222737·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033222720·

    LIPIDURE REWETTING DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CERALAS D10 810NM LASER, MODEL CERALAS D10-60

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

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·September 11, 1997

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013

    CANCELOUS LOCKING SCREW 2.4MM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    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

    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