BEUDAMED
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    IMPLANT, EYE SPHERE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517120731·Helix-T Plate, 56mm 3-Level

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838090040·Enables trained physicians to obtain cross-sect...

    OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POST-AURICULAR HEARING AID HC 880

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INCEPTA

    FDA Adverse Event
    Death ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 30, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 10, 2012

    PUMP MMT-522CAB PRDGM INS V2.2 BL EN PR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS, MED REL·Product code MDS·July 29, 2010

    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 8, 2019

    Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356

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

    Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356

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

    Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·March 25, 2019

    Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·April 23, 2021

    Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·April 23, 2021