BEUDAMED
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    CUSA Clarity Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306804236·Joseph Skin Hook, Single Prong, Length: 16 cm /...

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101087·HELVESTON "BARBIE" RETRACTOR

    SixFix Circular Fixation System

    FDA UDI
    Amdt Holdings, Inc.·00850030203526·Foot Arch, 180mm

    SixFix Circular Fixation System

    FDA UDI
    ARROWHEAD DE LLC·00855967006615·Foot Arch, 180mm

    TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGIQUEST ANCHORPORT SIL KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·September 15, 1999

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 23, 2017

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019

    EVIS EXERA III XENON LIGHT SOURCE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code NWB·January 6, 2021

    AERO TRACHEOBRONCHIAL STENT

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code JCT·June 21, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 4, 2011

    PRIME CARE (R) TRANSCEND MATTRESS

    FDA Adverse Event
    Malfunction ·PRIMUS MEDICAL LLC·Product code IKY·September 18, 2014

    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015