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    Symbia 6.7

    FDA 510(k)
    FDA Class 2 ·Radiology

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457205647·Conical Bl

    SCALP DURA RETRACTOR, MODEL KS00474

    FDA 510(k)
    FDA Class 2 ·Neurology

    PHYSICA TT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code MBH·May 10, 2023

    MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95

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

    VIEW NT

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·September 28, 2017

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SPAREKEY F/DRILL CHUCK CLAM RANGE - Ø4

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HTW·October 24, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2013

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·March 14, 2019

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024