BEUDAMED
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    SPEEDLINK TRANSVERSE CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054731·Strip Crown Forms

    TruLock

    FDA UDI
    Rmo, Inc.·00885797644930·TRULOCK Primer Activated Adhesive Kit (40 Capsule)

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002082·artVeneer life upper posteriors, L, B4

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112670·BARRON CORNEAL PUNCH 9.0MM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450139677·

    STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

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

    SUREFIT DISPERSIVE ELECTRODE

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

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013

    TOTALCARE-

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 4, 2011

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 20, 2008

    GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    TURBO-POWER LASER ATHERECTOMY CATHETER

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code MCW·October 7, 2025

    LACTOSORB SYSTEM 14 MM RAPID FLAP CLAMP

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·April 28, 2016

    LACTOSORB SYSTEM 14 MM RAPID FLAP CLAMP

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·April 28, 2016

    OXF ANAT BRG LT SM SIZE 3 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·May 20, 2021

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 2, 2011

    STERNALOCK 360 MULTI-IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·April 4, 2019

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 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