BEUDAMED
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    LEGION POROUS PRIMARY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·October 20, 2025

    POINT 4 FLOWABLE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM

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

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2021

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·May 1, 2011

    VERITY ADX SR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022

    PROFILE 3D

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021

    BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012