BEUDAMED
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    LACTOSORB ETHMOID STENT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    CTXA Hip Bone Mineral Densitometer

    FDA UDI
    MINDWAYS SOFTWARE, INC.·B052DICTXAHIP0·The CTXA Hip Bone Mineral Densitometer (CTXA Hi...

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00271311·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002131·artVeneer life lower posteriors, XL, D2

    DURA-CUF

    FDA UDI
    GE Medical Systems Information Technologies, Inc.·00840682110549·DURA-CUF, LARGE ADULT LONG, 1 TB BAYONET, 31 - ...

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167900021310·

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167S1900021310·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540030528·2.0mm Swanson Pilot Point Bur

    3D HDRAULIC FINE MICROMANIPULATOR MO-188NE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CHLORAPREP ONE STEP

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·May 10, 2021

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 14, 2011

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    CLARION

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·February 1, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 25, 2008

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 24, 2023

    X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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

    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