BEUDAMED
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    NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00271331·

    CTXA Hip Bone Mineral Densitometer

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

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002133·artVeneer life lower posteriors, L, D2

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167900021330·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540030535·3.0mm Swanson Pilot Point Bur

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167S1900021330·

    MENICON Z

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VERTE-STACK® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·October 7, 2014

    OT ULTRA METER

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

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2024

    HEARTSINE SAMARITAN 300P AND PAD PAK

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

    HIRES 90K

    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

    A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    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

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018