BEUDAMED
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    Mako Total Knee Application

    FDA 510(k)
    FDA Class 2 ·Neurology

    CETRA

    FDA UDI
    Orthofix US LLC·18257200134601·4.0mm X 15mm PRIMARY CONSTRAINED SELF-TAPPING S...

    EQUAL DOSE

    FDA 510(k)
    FDA Class 2 ·Radiology

    3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·October 8, 2008

    2.4MM CORTEX SCREW SELF-TAPPING 10MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·June 27, 2013

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 21, 2011

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

    MIDAS REX MR8

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025

    MOTOR MR8 ELECTRIC

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022

    NEXTAR INFRARED CAMERA

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021

    Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·May 20, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026