BEUDAMED
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    PROBEAT-FR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MedDrain

    FDA UDI
    ARMM INC.·10850082007582·MedDrain 32 Fr Right Angle Thoracic Catheter 6 ...

    RIGIDLOOP

    FDA UDI
    Medos International Sàrl·10886705022786·RIGIDLOOP Cortical System Instrument Tray

    ihcDirect® Cytokeratin 20 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596429·Clone R1001

    ihcDirect® Cytokeratin 20 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596436·Clone R1001

    ihcDirect® Cytokeratin 20 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934178·Clone R1001

    ihcDirect® Cytokeratin 20 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934185·Clone R1001

    N/A

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369610·THOMAS RADIOLUCENT LEG SPLINT STRAP LARGE

    SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Idys LLIF 3DTi

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 17, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·November 6, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 17, 2013

    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