BEUDAMED
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    MODIFICATION TO SYNTHES (USA) POLYPIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier Explorers

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783006025·CAVITY FINDER DE 3CH

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085020778·Auramine O Stain 250ml bottle

    Lesser Metatarsal Shortening System

    FDA UDI
    Paragon 28, Inc.·00889795123626·Met Shortening Implant, Slot, 2.7

    FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES

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

    ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094

    FDA 510(k)
    FDA Class 1 ·Hematology

    DIALYZER

    FDA Adverse Event
    HAEMOTRONIC LTD.·Product code FJI·September 28, 1994

    BIO-CORKSCREW SUTURE ANCHOR

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 2, 2024

    SCREWDRIVER TI5, LENGTH 300MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·February 28, 2013

    ENDEAVOR RAPID EXCHANGE CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·February 22, 2011

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·February 26, 2008

    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

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; 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