BEUDAMED
    36 results · 77ms · Sources: EU EUDAMED, US FDA

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    eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

    eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

    eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

    eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

    eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

    eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·August 29, 2018

    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

    CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. 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

    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. 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

    CIVCO Sales Demo Kit. REF DEMOGPGUIDE 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

    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. 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

    SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·September 5, 2018

    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·September 5, 2018

    CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018