BEUDAMED
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    SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ArgenPMMA 98x20-C2

    FDA UDI
    ARGEN CORPORATION, THE·D818120882·Crown And Bridge, Temporary, Resin

    Mini Unicycle™

    FDA UDI
    Ortho Organizers, Inc.·00190707056834·Mini Unicycle™ .120” Ligature Ties - Neon Pink

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450194454·

    SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

    IMC INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEXIVA MAXZERO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 14, 2025

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 31, 2019

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013

    EEA 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·September 26, 2014

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 11, 2011

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·February 21, 2019

    ASANTE SNAP INSULIN PUMP SYSTEM

    FDA Adverse Event
    Injury ·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014

    Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN) designed to reduce risk of accidental needle sticks to the operators. The lateral port is equipped with a non-return silicone valve and a polypropylene snap cap with a winged polypropylene hub for fastening.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·December 28, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021