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    Artiglass NRFitTM Tip L.O.R. Glass Syringes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RIGIDFIX

    FDA UDI
    DEPUY MITEK, LLC·10886705003136·RIGIDFIX Tibial Guide Frame 40-90mm (Plus or Mi...

    Ophthalmic Hooks

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)

    CADD

    FDA UDI
    ICU MEDICAL, INC.·00610586016960·

    INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EYEVAN7285

    FDA UDI
    EYEVAN INC.·04571445037617·

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·October 22, 2008

    SYS 6 RECIP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 4, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·April 2, 2019

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 2, 2019

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019