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

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    LEONE MONOIMPLANT FOR O-RING OVERDENTURE

    FDA 510(k)
    FDA Class 2 ·Dental

    POINT PRESSURE ITALIA SOCIETA' A RE

    Manufacturer
    🇮🇹 Italy

    ARES

    Device
    EU MDR · Eu Md Class 2b ·GNG S.R.L.·On the market·1 country

    LETTINO ARES

    Device
    EU MDR · Eu Md Class 1 ·FISIOTECH srl·On the market

    Dual Bore Cannula 27G

    Device
    EU MDR · Eu Md Class 2a ·AKTIVE SRL·On the market·32 countries

    Dual Bore Cannula 25G

    Device
    EU MDR · Eu Md Class 2a ·AKTIVE SRL·On the market·32 countries

    Dual Bore Cannula 20G

    Device
    EU MDR · Eu Md Class 2a ·AKTIVE SRL·On the market·32 countries

    Cannula Dual Bore 23G

    Device
    EU MDR · Eu Md Class 2a ·AKTIVE SRL·On the market·32 countries

    Dual Bore Cannula 25G, 36mm

    Device
    EU MDR · Eu Md Class 2a ·AKTIVE SRL·On the market·32 countries

    Dual Bore Cannula 23G, 36mm

    Device
    EU MDR · Eu Md Class 2a ·AKTIVE SRL·On the market·32 countries

    ARES

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·FISIOTECH srl·1 device

    DUAL BORE CANNULAE / CANNULA DUAL BORE

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·AKTIVE SRL·6 devices

    INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·May 24, 2017

    OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·May 24, 2017

    PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·May 24, 2017

    Spectrum Medical Quantum Standard heat exchanger

    FDA Enforcement
    Class II ·Terminated·QURA S.R.L.·August 18, 2021

    Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.

    FDA Enforcement
    Class II ·Ongoing·Villa Sistemi Medicali S.P.A.·January 8, 2020

    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

    FDA Enforcement
    Class II ·Terminated·HEALTH ROBOTICS S.R.L.·January 18, 2017

    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 9, 2015

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015