BEUDAMED
    67 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Vented Vial Adapter 20mm

    FDA 510(k)
    FDA Class 2 ·General Hospital

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

    PLANCET

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

    DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTICROSS? 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 2, 2025

    OPTICROSS? 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 7, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 20, 2025

    OPTICROSS 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·November 25, 2024

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 12, 2025

    OPTICROSS? 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025

    OPTICROSS? 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 11, 2025

    OPTICROSS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025

    OPTICROSS? 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 1, 2025

    OPTICROSS? 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·October 1, 2025

    OPTICROSS 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 31, 2025

    OPTICROSS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025

    OPTICROSS 6 HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·November 26, 2024

    OPTICROSS HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025