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

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    Filters Country: Italy ×

    PRO-ACTIVE S.R.L.

    Manufacturer
    🇮🇹 Italy

    Pro-Eko Srl

    Manufacturer
    🇮🇹 Italy·3 Basic UDI-DIs·8 Devices

    Pro Medicare S.r.l.

    Manufacturer
    🇮🇹 Italy

    4 PRO s.r.l.

    Manufacturer
    🇮🇹 Italy

    PRO DATA S.r.l.

    Manufacturer
    🇮🇹 Italy·1 Basic UDI-DI·1 Device

    11.50/4RF - DEAMBULATORE 4 RUOTE

    Device
    EU MDR · Eu Md Class 1 ·VASSILLI S.R.L.·On the market

    Formalina Neutra Tamponata 4%

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    DIFF STAIN QUICK KIT

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    MP@web

    Device
    EU MDR · Eu Md Class 1 ·PRO DATA S.r.l.·On the market

    SOLUZIONE DI LUGOL

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    MAY-GRÜNWALD

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    GIEMSA

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    EMATOSSILINA SECONDO HARRIS

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    PAPANICOLAOU SOLUZIONE EA50

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    PAPANICOLAOU SOLUZIONE OG6

    Device
    EU IVDR · Eu Ivd Class A ·Pro-Eko Srl·On the market

    X-FRAME DRF

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·ITALRAY s.r.l.·1 device

    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is 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).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    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

    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is 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).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017