BEUDAMED
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    Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

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

    ASO Speed Lacer Ankle Stabilizer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236169·

    VariAx

    FDA UDI
    Stryker GmbH·37613153067970·LOCKING SCREWS, CROSS-PIN

    PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2011

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 5, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 12, 2013

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026