BEUDAMED
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    ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810017331·REAMERS

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00173031·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040093655·Maxima Reamers 25mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450179673·

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 20, 2024

    AGILITY STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 8, 2022

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·March 13, 2013

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 25, 2011

    LIFESHIELD BIFURCATED EXTENSION SET

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPB·February 19, 2008

    bk3000 Ultrasound System w/battery; Model No. 2300-66; 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