BEUDAMED
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    AL-40

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

    Invotec Quick Pack Nasal Balloon Packing

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501020683·Invotec Quick Pack Nasal Balloon Packing, Silicone

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450252871·

    Single Use Biliary Stent V

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170185816·Single Use Biliary Stent V

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033463864·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033463833·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033463871·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033463857·

    Klaitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100150·Counter Torque, Low Profile Assembly

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033463840·

    COBAS® MPX - 480T

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

    POWDERED PATIENT EXAMINATION GLOVES, LATEX

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENVOY AND VISTA BRITE TIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 19, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 2, 2011

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    COBAS® MPX - 480T

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

    COBAS® MPX - 480T

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

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·May 1, 2014