CIVCO Medical Instruments Co., Inc.
CIVCO Medical Instruments Co., Inc. holds FDA 510(k) medical device clearances, first cleared 1982, most recent 2026, with 36 FDA device recalls on record.
Top product codes for CIVCO Medical Instruments Co., Inc.
FDA recalls by CIVCO Medical Instruments Co., Inc.
10 most recent of 36- Z-1734-2026 — eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- Z-1738-2026 — eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
- Z-1733-2026 — eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
- Z-1736-2026 — eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
- Z-1732-2026 — eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
- Z-1735-2026 — eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
- Z-1737-2026 — eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
- Z-1731-2026 — eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- Z-1892-2025 — BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
- Z-0395-2022 — VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by CIVCO Medical Instruments Co., Inc.
- K260114 — Align® Cover and Pad Guidance Tool
- K231783 — VitroPRO
- K222052 — VitroPRO
- K211270 — CIV-Clear cover
- K163313 — ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
- K160806 — Verza Guidance System
- K131161 — EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
- K131528 — NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
- K080072 — MRI PATIENT POSITIONING DEVICES
- K013721 — SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
- K002546 — CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
- K992152 — GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF
- K991236 — GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,
- K970513 — GENERAL PURPOSE TRANDUCER COVER
- K970514 — DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE
- K970515 — GENERAL PURPOSE LATEX TRANSDUCER COVERS
- K943393 — CIVCO PROBE BOOT/CORD COVER
- K900016 — TRANS/R - FP(3)
- K895614 — CIVCO LATEX ULTRASOUND SHEATHS
- K882383 — MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
- K875128 — TRANS/R NEEDLE GUIDE
- K875236 — TRANS/P NEEDLE GUIDE
- K875240 — TRANS/V NEEDLE GUIDE
- K875241 — CIVCO SEED IMPLANT NEEDLE GUIDE
- K871413 — CIVCO STEPPER
- K862481 — CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
- K844472 — CIVCO SCAN DRAPE
- K843573 — CIVCO-SUPER SCAN/BIOPSY GUIDE
- K841332 — CIVCO/SUPER SCAN
- K820269 — RNG SERIES ULTRASOUND NEEDLE/CATH. GDS
Data sourced from openFDA. This site is unofficial and independent of the FDA.