BEUDAMED
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    AUTO SUTURE SURGIPORT SPIRAL SLEEVE

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

    Intellijet

    FDA UDI
    Smith & Nephew, Inc.·00885554007657·SOD INTELIJET CANN W/ OLYMPUS INTERFACE

    Instruments

    FDA UDI
    Nuvasive, Inc.·00887517382689·ALGI Chisel, 7mm Straight

    3M™ Unitek™

    FDA UDI
    3M COMPANY·30605861027138·3M™ Unitek™ Stainless Steel First Primary Molar...

    Barricade Coil System

    FDA UDI
    BALT USA LLC·00818053021220·Barricade Coil System (BCS) is intended for the...

    PicoMix Syringe

    FDA UDI
    G21 SRL·08058964725042·Bone Cement Mixing System (120 gr)

    SS Crown 4LL

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199001230·

    MyndMove

    FDA UDI
    MyndTec Inc·00692520001232·

    MyndMove

    FDA UDI
    MyndTec Inc·06925209001235·

    Emergent Respiratory

    FDA UDI
    MDL Solutions Incorporated·00850071887129·Breathing Circuit with Small S3 Mask

    Revolution External Plating System

    FDA UDI
    Metalogix·00854641008051·Implant Tray

    Denovo Stainless Steel Primary Molar Crown

    FDA UDI
    Denovo Dental, Inc.·00810059293373·Denovo Stainless Steel Primary Molar Crown - 1s...

    PicoMix Syringe

    FDA UDI
    G21 SRL·08058964726261·Bone Cement Mixing System (120 gr)

    CONLIN MOLAR BAND

    FDA UDI
    Ortho Arch Company Inc·D90990012312·MOLAR BAND CONLIN RX UPPER RIGHT 40

    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

    XBraid S

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00840277401144·Suture

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707050689·.022 LR6 CV DBT -25T 0A 4O

    ACUMED WRIST ARTHRODESIS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEONATAL BIOTINIDASE KIT, MODEL 3018

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEENEN PANCREATIC STENT SET

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·January 10, 2019