BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    AQUILION ONE VISION, V4.90

    FDA 510(k)
    FDA Class 2 ·Radiology

    ArgenZ HT+ 98x25 OM2

    FDA UDI
    ARGEN CORPORATION, THE·D818122109·Dental porcelain/ceramic restoration kit

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053203·PEERLESS 2NDMOL 6DEG UL WDX-10T X 022

    ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EIZO, MODEL FC-2091

    FDA 510(k)
    FDA Class 2 ·Radiology

    2000 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE ¿ ROUND LAKE·Product code LHI·September 17, 2019

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 21, 2013

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·May 24, 2011

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·August 14, 2008

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018