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CIVCO MEDICAL INSTRUMENTS CO., INC.

Last updated September 17, 2026

Information

Country: US
Address: 750 Lois Lane, Coralville, IA, 52241
Website: civco.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(319)248-6502
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1937223
DUNS Number: 134614411

Catalogue (1128)

Page 1 of 23

Device	Model / Reference	Registries	Class	Status
Needle Guide	657-069	FDA UDI	Class II	Active
Biopsy Starter Kit	639-019	FDA UDI	Class II	Active
Verza Guidance System	676-216	FDA UDI	Class II	Active
EX3 Stepper	676-177	FDA UDI	Class I	Active
Verza Guidance System	642-503	FDA UDI	Class II	Active
Needle Guide Bracket	674-054	FDA UDI	Class II	Active
NeoGuard™ Transducer Cover	610-1348	FDA UDI	Class II	Active
Biopsy Starter Kit	10787043	FDA UDI	Class II	Active
Biopsy Starter Kit	667-126	FDA UDI	Class II	Active
Biopsy Bracket	680-171	FDA UDI	Class II	Active
Biopsy Starter Kit	E8385RJ	FDA UDI	Class II	Unknown
Tracking Bracket Starter Kit	11292182	EUDAMEDFDA UDI	Class II	Active
Classic Stepper	639-055	FDA UDI	Class II	Active
Biopsy Bracket	614-068	FDA UDI	Class II	Active
Needle Forceps	610-611	FDA UDI	Class I	Active
Biopsy Bracket	680-128	FDA UDI	Class II	Active
Biopsy Starter Kit	680-104	FDA UDI	Class II	Active
Scanning Kit	612-056	FDA UDI	Class II	Unknown
AccuSITE Needle Guide	610-1017, 610-1030, 610-1123	FDA UDI	Class II	Active
AccuSITE™ Needle Guide	610-2338	FDA UDI	Class II	Active
Tracking Bracket Starter Kit	10441184	FDA UDI	Class II	Active
Needle Guide	644-068	FDA UDI	Class II	Active
Cradle	610-1396	EUDAMEDFDA UDI	Class II	Active
Biopsy Bracket	657-095	FDA UDI	Class II	Active
Reusable Acoustic Standoff Pad	610-459	FDA UDI	Class II	Unknown
BX2 Biopsy Bracket	680-110	EUDAMEDFDA UDI	Class II	Active
NeoGuard™	UA0068	EUDAMEDFDA UDI	Class II	Active
Cook CollectEVAC	CCE-10	FDA UDI	Class II	Active
Transducer Cover	610-795	FDA UDI	Class II	Active
Verza Biopsy Bracket	657-079	FDA UDI	Class II	Active
Needle Guide	657-072	FDA UDI	Class II	Active
Biopsy Bracket	680-085	FDA UDI	Class II	Active
Needle Guide	680-116	FDA UDI	Class II	Active
Needle Guide	680-121, 680-121-5	FDA UDI	Class II	Active
Biopsy Starter Kit	H4908NB	FDA UDI	Class II	Active
Needle Guide	667-119	FDA UDI	Class II	Active
Biopsy Starter Kit	639-036	FDA UDI	Class II	Active
Verza Guidance System	680-174	FDA UDI	Class II	Active
eTRAX™ Needle Sensor	5408134	FDA UDI	Class II	Unknown
Biopsy Starter Kit	680-170	FDA UDI	Class II	Active
Biopsy Starter Kit	667-071	FDA UDI	Class II	Active
Variety Pack	H2O-013	FDA UDI	Class II	Active
omniTRAX Patient Tracker	610-1228	FDA UDI	Class II	Active
PROcovers™	610-042	EUDAMEDFDA UDI	Class II	Active
Verza Guidance System	11508588	FDA UDI	Class II	Active
NeoGuard™ Transducer Cover	610-843, 610-843-5	FDA UDI	Class II	Active
Needle Guide	610-590	FDA UDI	Class II	Active
Biopsy Starter Kit	657-030	FDA UDI	Class II	Unknown
eTRAX™ Needle System Starter Kit	610-1401	FDA UDI	Class II	Active
EX3 Stepper	614-119	FDA UDI	Class I	Active

Related Companies

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FDA Recalls (53)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 2, 2026	Z-1738-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Mar 2, 2026	Z-1734-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Mar 2, 2026	Z-1736-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Mar 2, 2026	Z-1733-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Mar 2, 2026	Z-1732-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Mar 2, 2026	Z-1737-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Mar 2, 2026	Z-1731-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Mar 2, 2026	Z-1735-2026	—	open, classified	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
May 1, 2025	Z-1892-2025	—	open, classified	During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
Oct 8, 2021	Z-0398-2022	—	terminated	There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Oct 8, 2021	Z-0395-2022	—	terminated	There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Oct 8, 2021	Z-0396-2022	—	terminated	There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Oct 8, 2021	Z-0397-2022	—	terminated	There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Nov 2, 2018	Z-0566-2019	—	terminated	—
Nov 2, 2018	Z-0574-2019	—	terminated	—
Nov 2, 2018	Z-0570-2019	—	terminated	—
Nov 2, 2018	Z-0573-2019	—	terminated	—
Nov 2, 2018	Z-0569-2019	—	terminated	—
Nov 2, 2018	Z-0567-2019	—	terminated	—
Nov 2, 2018	Z-0564-2019	—	terminated	The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Nov 2, 2018	Z-0562-2019	—	terminated	The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Nov 2, 2018	Z-0565-2019	—	terminated	—
Nov 2, 2018	Z-0568-2019	—	terminated	—
Nov 2, 2018	Z-0571-2019	—	terminated	—
Nov 2, 2018	Z-0575-2019	—	terminated	—
Nov 2, 2018	Z-0572-2019	—	terminated	—
Nov 2, 2018	Z-0563-2019	—	terminated	The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Nov 2, 2018	Z-0576-2019	—	terminated	—
Jul 30, 2018	Z-2947-2018	—	terminated	The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Jul 30, 2018	Z-2946-2018	—	terminated	The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Feb 23, 2018	Z-2888-2018	—	terminated	A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Oct 21, 2015	Z-0287-2016	—	terminated	Sterility of the product cannot be assured.
Oct 21, 2015	Z-0288-2016	—	terminated	Sterility of the product cannot be assured.
Oct 21, 2015	Z-0286-2016	—	terminated	Sterility of the product cannot be assured.
Oct 21, 2015	Z-0289-2016	—	terminated	Sterility of the product cannot be assured.
Oct 21, 2015	Z-0290-2016	—	terminated	Sterility of the product cannot be assured.
Feb 26, 2015	Z-1400-2015	—	terminated	Leaks were detected in the recalled lot which may compromise the sterility of the product.
Aug 1, 2014	Z-2558-2014	—	terminated	A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Oct 25, 2013	Z-0802-2014	—	terminated	Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Oct 25, 2013	Z-0803-2014	—	terminated	Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
May 7, 2012	Z-1956-2012	—	terminated	The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
May 7, 2012	Z-1955-2012	—	terminated	The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
May 7, 2012	Z-1952-2012	—	terminated	The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
May 7, 2012	Z-1953-2012	—	terminated	The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
May 7, 2012	Z-1954-2012	—	terminated	The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Jan 21, 2011	Z-1607-2011	—	terminated	Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.
Dec 30, 2010	Z-3019-2011	—	terminated	Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Dec 30, 2010	Z-3021-2011	—	terminated	Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Dec 30, 2010	Z-3020-2011	—	terminated	Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Jul 20, 2010	Z-2242-2010	—	terminated	Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
Jun 18, 2008	Z-2137-2008	—	terminated	A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
Feb 25, 2008	Z-1608-2008	—	terminated	Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
Jan 16, 2008	Z-1054-2008	—	terminated	Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).