BEUDAMED
    296 results · 47ms · 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 Status: Open, Classified ×

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

    Infant Heel Warmers w/strap, Reference # 989805603201 1223

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code IMD·November 29, 2021

    Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code IMD·November 29, 2021

    DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023

    DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023

    DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPR·September 21, 2023

    The Oncology Essentials Package of the Spectral CT imaging system.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·March 29, 2024

    Ingenia 3.0T, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Intera 1.5T Power/Pulsar, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Achieva 3.0T, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Intera 1.5T Achieva IT Nova, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

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

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

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

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MOS·June 5, 2024

    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024