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Civco Medical Instruments Co. Inc.

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 recall (Z-1731-2026)Civco Medical Instruments Co. Inc.2026-04-01
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 recall (Z-1732-2026)Civco Medical Instruments Co. Inc.2026-04-01
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 recall (Z-1733-2026)Civco Medical Instruments Co. Inc.2026-04-01
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 recall (Z-1734-2026)Civco Medical Instruments Co. Inc.2026-04-01
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 recall (Z-1735-2026)Civco Medical Instruments Co. Inc.2026-04-01
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 recall (Z-1736-2026)Civco Medical Instruments Co. Inc.2026-04-01
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 recall (Z-1737-2026)Civco Medical Instruments Co. Inc.2026-04-01
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 recall (Z-1738-2026)Civco Medical Instruments Co. Inc.2026-04-01
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) pro recall (Z-1892-2025)Civco Medical Instruments Co. Inc.2025-05-30
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs recall (Z-0286-2016)Civco Medical Instruments Co. Inc.2015-11-17
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 1 recall (Z-0287-2016)Civco Medical Instruments Co. Inc.2015-11-17
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18G recall (Z-0288-2016)Civco Medical Instruments Co. Inc.2015-11-17
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with In recall (Z-0289-2016)Civco Medical Instruments Co. Inc.2015-11-17
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in nee recall (Z-0290-2016)Civco Medical Instruments Co. Inc.2015-11-17

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Every clearance here is in the API, with alerts when new ones post.