BEUDAMED
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    Ingenia Elition R5.7.1 SP4 MR Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

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

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496006220·WONDER MODEL 30, SIZE ML, PAPRIKA, GRADUATED CO...

    RIGIDLOOP

    FDA UDI
    Medos International Sàrl·10886705022762·RIGIDLOOP Standard Depth Gauge 10-130mm Plus or...

    MEGA PLUS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665580542·Rod(CoCr), Ø5.5 x 300mm

    NOVEOS Conjugate IgE

    FDA UDI
    HYCOR BIOMEDICAL LLC·00816879028836·

    NOVEOS Conjugate IgE

    FDA UDI
    HYCOR BIOMEDICAL LLC·00816879029635·

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247416·No-Profile Interbody, 39mm x 30mm x 20mm, 30 Deg

    N/A

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369597·THOMAS RADIOLUCENT LEG SPLINT STRAP

    SHILEY

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code JOH·March 6, 2026

    BLINK CL LUBRICANT EYE DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNERGY VERSITREL

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·November 6, 2014

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 1, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 5, 2013

    4.75 MM FIXED LOCKING SCREW 3.5 HEX

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·November 16, 2018

    M2A 1 PC SHELL 38MMX54MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·August 16, 2013

    COMP RVS CNTRL 6.5X35MM ST/RST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 27, 2022

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013