BEUDAMED
    64 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    Achieva 3.0T TX for PET Model Number (REF): 781479

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Achieva 1.5T Initial system Model Number (REF): 781178

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    SmartPath to dStream for 3.0T Model Number (REF): 782145

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corp.·February 17, 2016

    Ingenia 1.5T S Model Number (REF): 781347

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024