BEUDAMED
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    Legend® Acetabular Shell

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·June 25, 2010

    INTRAGen

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

    SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    UNKNOWN DEPUY PATELLA

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HTG·July 23, 2013

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 21, 2025

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·March 11, 2026

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026