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

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    Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    WIENER LAB. ALP 405

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    DIMESION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC·Product code MMI·October 24, 2008

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·August 4, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·July 9, 2013

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 12, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024

    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