BEUDAMED
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    OPTIBOND XTR

    FDA 510(k)
    FDA Class 2 ·Dental

    Bur PM2-70 80K diamC Ø1.5x80 St

    FDA UDI
    Bien-Air Surgery SA·17630055519495·

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942748747·SUPPLY OR KIT

    HHM

    FDA UDI
    Oticon A/S·05707131164131·K140, RITE CBE HHM

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471156155·V D-Form 018X025

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450445174·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383500999·Gutta Percha Points is used to root canal filin...

    NA

    FDA UDI
    STERILMED, INC.·10888551037051·BUR CARBIDE ROUND FLUTED LONG 8 FLUTES

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326425909·NiTi SE Archwire, D-FORM .018x.025 10EA

    INPULSE DENTAL LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    BLAKE DRAIN

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GBX·March 24, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    SYNOX SX 60/15 BP

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·August 5, 2008

    MOTOBAND CP IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code HRS·March 22, 2019

    DUREPAIR®

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code GXQ·August 8, 2023

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    B125M Patient Monitor, REF 6160000-004-XXXXXX

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022