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    Wireless Digital Flat Panel Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZenFlex

    FDA UDI
    Kerr Corporation·00195062030017·Rotary Files

    N/A

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551921·In-Ovation R RNC/BASE/EURO 018 UL5-5 CS-BC HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183U1·IN-OVATION® R EURO 018 U5-5 CS-1BC HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183L1·IN-OVATION® R EURO 018 L5-5 CS-1BC HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551821·IN-OVATION® R EURO 018 UL/5-5 CS-BC HK

    S4 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROVITEMP

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·June 14, 2024

    LOW PRESSURE BLACK MAX HANDPIECE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 17, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 19, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014