BEUDAMED
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    Evenflo Premium Double Electric Breast Pump (Model 4018)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    inCoris ZI

    FDA UDI
    SIRONA Dental Systems GmbH·E27662304812·inCoris ZI mono S F0.5 3 Stück/pcs.

    Andorate Biopsy Valve, Andorate Biopsy Irrigator

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·October 22, 2014

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·August 12, 2011

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY-SAN JOSE·Product code HIF·July 16, 2013

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025