BEUDAMED
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    SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Triad

    FDA UDI
    Nuvasive, Inc.·00887517062567·Triad TLIF Allograft Scraper, Straight

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106810·Zirlux Titanium Abutment 3 mmH compatible with:...

    Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501021055·Custom Cut Silicone Sheeting For Internal Nasal...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450133095·

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 4, 2025

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 19, 2025

    AU5, AU6

    FDA 510(k)
    FDA Class 2 ·Radiology

    POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025

    FREEDOM CONSTRAINED HEAD STD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWZ·July 17, 2012

    FREEDOM CONSTR. LINER +5 SZ 23

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWZ·July 17, 2012

    RESPIRONICS VITAL SENSE CAPSULE SENSOR

    FDA Adverse Event
    Product code GWK·March 13, 2013

    GATEWAY BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code GBA·March 8, 2011

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 20, 2014

    CD HORIZON

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 16, 2016

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024