BEUDAMED
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    PLEURX PLEURAL CATHETER AND DRAINAGE KITS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106420·Zirlux UCLA Plastic Abut Eng

    K-Splint Internal Nasal Splint

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501020843·K-Splint Internal Nasal Splint Size: Medium 0.5...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100420·Assembly, Caddie, Adjustable Cross Links

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

    CT PERFUSION 2

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSIGHT IMAGE GUIDED SURGICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ORTHOBLAST

    FDA Adverse Event
    Injury ·INTEGRA LIFE SCIENCES·Product code MBP·September 27, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·March 19, 2013

    HEAD FOR ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code KWY·February 24, 2011

    RIATA ACTIVE FIXATION LEAD

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

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 16, 2018

    COPELAND THN SHL COCR/HA HUMS3

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWS·August 28, 2025

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019