BEUDAMED
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    ROSA ONE Brain Application

    FDA 510(k)
    FDA Class 2 ·Neurology

    Curette

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102107·SHEPHERD CAPSULE POLISHER LEFT

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

    XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASCO MIC AND MIC/ID PANELS (ERTAPENEM)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·December 22, 2025

    MERIT HEMOSTASIS VALVE

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DQX·August 25, 2011

    MODULEX

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES TE·Product code LXH·September 19, 2025

    HARMONY RETRACTOR SLIDERS (LONG SLIDER)

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE·Product code GAD·October 30, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 26, 2011

    PLUM XLD 110V LA

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 12, 2013

    NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

    FDA Enforcement
    Class II ·Ongoing·Orthosoft, Inc. dba Zimmer CAS·March 9, 2022

    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·July 3, 2024

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023