BEUDAMED
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    LACTOSORB RAPIDFLAP

    FDA 510(k)
    FDA Class 2 ·Dental

    HI-TORQUE STEELCORE

    FDA UDI
    ABBOTT VASCULAR INC.·08717648013942·HI-TORQUE STEELCORE 18 Peripheral GuideWire 190 cm

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00328101·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450573334·

    NBP-ONE

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935109204·

    WALLSTENT ENTERNAL PROSTHESIS

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

    GERATHERM BABYWATCH TEMPERATURE MONITOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code MCX·February 28, 2011

    PRE-SHAPED PROWLER MICROCATHETERS

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code KRA·December 18, 2007

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·August 11, 2023

    TMJ SYSTEM CROSS DRIVE FOSSA SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 1, 2018

    TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·June 1, 2018

    TMJ SYSTEM CROSS DRIVE FOSSA SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 1, 2018

    TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·June 1, 2018

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 11, 2024

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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