BEUDAMED
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    SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER

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

    LANDANGER

    FDA UDI
    LANDANGER·03661219202066·

    LoFric®

    FDA UDI
    Wellspect AB·07333387037523·Single Use Urinary Catheter LoFric Nelaton 8" 14FR

    LoFric®

    FDA UDI
    Wellspect AB·07392532135132·Single Use Urinary Catheter LoFric Nelaton 8" 14FR

    PLANO LENS

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111635·

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20314401·BioTorque wires Straight-Arch-F. max. .016"x.016"

    NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

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

    ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

    FDA Adverse Event
    Injury ·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022

    TI MATRIX TOP LOADING POLYAXIAL HEAD

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code NKB·April 2, 2013

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 28, 2011

    BD LOGIC BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP·Product code NBW·April 18, 2008

    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

    FDA Enforcement
    Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016