BEUDAMED
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    FACTOR II DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    Barricade Coil System

    FDA UDI
    BALT USA LLC·00818053021329·Barricade Coil System (BCS) is intended for the...

    3M™ Unitek™

    FDA UDI
    3M COMPANY·30605861027275·3M™ Unitek™ Stainless Steel First Primary Molar...

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

    Denovo Stainless Steel Primary Molar Crown

    FDA UDI
    Denovo Dental, Inc.·00810059293441·Denovo Stainless Steel Primary Molar Crown - 1s...

    Khaimi Concentrator, 0.33 mL

    FDA UDI
    KATALYST SURGICAL LLC·00840096203684·

    CONLIN MOLAR BAND

    FDA UDI
    Ortho Arch Company Inc·D90990013313·MOLAR BAND CONLIN RX LOWER RIGHT 30

    XBraid S

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00840277401243·Suture

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707050788·.022 UR6 CV STD -14T 0A 14O

    MENICON Z

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS

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

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·May 28, 2014

    LIFEGUARD NON-CORING SAFETY INFUSION SET

    FDA Adverse Event
    Malfunction ·VYGON·Product code FPA·October 22, 2010

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code LZH·December 27, 2012

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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