BEUDAMED
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    SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113578·PRESET 600 MICRON KNIFE (BX/5)

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009276·PedFuse, Rod, Straight, Bulleted, 5.5mm X 60mm

    CRADLE SLING ECONOMY

    FDA UDI
    DARCO INTERNATIONAL, INC.·00609271020788·Extra-large

    ODONTOSURGE 3

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES (USA) RESORBABLE TACK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    PORTEX GENERAL ANESTHESIA CIRCUITS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 13, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 16, 2011

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 8, 2008

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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