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

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    INVACARE LIFT CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950018536·FORCEP ROOT STEIGLITZ 45 DEGREE 5-1/4" 13.5CM

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102473·Astra®-compatible Aqua 3.5/4.0mm Esthetic Abutm...

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964016989·The ENDO CARRY-ON Procedure Kit contains all of...

    Rinsing Fluid 0.5 L 8/pkg

    FDA UDI
    M DIALYSIS INC.·07332699000379·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002171·artVeneer life lower posteriors, XL, BL2

    ACCESSORY DRAIN BAG

    FDA Adverse Event
    Malfunction ·GAMBRO·Product code KDI·November 14, 2010

    SURGITEK MAMMARY PROSTHESIS

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·May 23, 1994

    CBYON SURGICAL OPERATING SYSTEM (SOS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DELTA 16 TACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCESSORY DRAIN BAG

    FDA Adverse Event
    Malfunction ·GAMBRO·Product code KDI·November 14, 2010

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 12, 2014

    COUPLER AC ZOOM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code FEM·December 17, 2021

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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.·November 2, 2016