BEUDAMED
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    ENVOY AND VISTA BRITE TIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    DEPUY SPINE, LLC·10705034007236·SPINAL INSTRUMENT POSTERIOR SPREADER 15mm

    Nobel

    FDA UDI
    Preat Corporation·00842092167106·NobelBiocare™ Tri-Lobe-compatible 6.0mm Non-Eng...

    Immunalysis

    FDA UDI
    IMMUNALYSIS CORP·00840937108260·Opiates Urine Calibrator 2000, 1

    Single Use Biliary Stent V

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170185472·

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025

    BARCOMED 2MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    RETIC CHEX LINEARITY

    FDA 510(k)
    FDA Class 2 ·Hematology

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·March 12, 2013

    LVAS KIT, HM-II, EUROPEAN, EP

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·February 16, 2011

    MICROSTAAR INJECTOR

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code MSS·February 21, 2008

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 19, 2025

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 22, 2025

    TALENT AUI

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·April 8, 2014

    TALENT OCCLUDER

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·April 8, 2014

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 28, 2018