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CIVCO MEDICAL INSTRUMENTS CO., INC.

Last updated September 17, 2026

What CIVCO MEDICAL INSTRUMENTS CO., INC. makes

CIVCO MEDICAL INSTRUMENTS CO., INC. manufactures ultrasound imaging system tracking positioners, needle guides (both single-use and reusable), body-surface ultrasound imaging transducer covers, electromagnetic surgical navigation device tracking systems, prostate brachytherapy system applicators, and medical equipment/instrument drapes.

The company's portfolio includes Class I and Class II devices listed in the FDA UDI registry, and it is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does CIVCO MEDICAL INSTRUMENTS CO., INC. manufacture?

Where is CIVCO MEDICAL INSTRUMENTS CO., INC. based?

CIVCO MEDICAL INSTRUMENTS CO., INC. is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list CIVCO MEDICAL INSTRUMENTS CO., INC.'s devices?

The company's devices are listed in the FDA UDI registry, which is specifically mentioned in the device data as the registry where their products are registered.

How are CIVCO MEDICAL INSTRUMENTS CO., INC.'s devices classified?

The company manufactures Class I and Class II medical devices, as explicitly stated in the device data. These classifications indicate the level of regulatory control required for each device type.

AI-generated from registry data and not verified by a human reviewer.

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 (1137)

Page 3 of 23

Device	Model / Reference	Registries	Class	Status
BX2 Needle Guide	680-112	FDA UDI	Class II	Active
Biopsy Starter Kit	639-034	FDA UDI	Class II	Active
Needle Guide	676-167	FDA UDI	Class II	Active
Tracking Bracket	657-041	FDA UDI	Class II	Active
Intuit Roll Transducer Cover	610-1347, 610-1347-5	EUDAMEDFDA UDI	Class II	Active
eTRAX™ Needle	610-1411-01	FDA UDI	Class II	Unknown
Biopsy Starter Kit	613-209	FDA UDI	Class II	Active
Gus	610-2168	FDA UDI	Class I	Active
Toshiba Verza Biopsy Bracket	680-152	FDA UDI	Class II	Active
Biopsy Starter Kit	10658470	FDA UDI	Class II	Active
Biopsy Starter Kit	H4908ND	FDA UDI	Class II	Active
Gus	610-720	FDA UDI	Class I	Active
Multi-Purpose Workstation ™ Stepper	7700-2	FDA UDI	Class II	Active
Needle Guide Bracket	P27063-01	FDA UDI	Class II	Active
Biopsy Starter Kit	657-026	FDA UDI	Class II	Unknown
Biopsy Starter Kit	612-085	FDA UDI	Class II	Active
Needle Guide	613-198	FDA UDI	Class II	Active
Transducer Cover	610-2424	FDA UDI	Class II	Active
Biopsy Starter Kit	667-104	FDA UDI	Class II	Unknown
CIV-Flex™ Transducer Cover	610-1028	FDA UDI	Class II	Active
CIV-Flex™ Transducer Cover	610-1600	FDA UDI	Class II	Active
Needle Guide	676-206	FDA UDI	Class II	Active
Transducer Cover	610-046	FDA UDI	Class II	Active
eTRAX™ Needle	610-1411-10	FDA UDI	Class II	Unknown
eTRAX™ Needle	610-1213-01	FDA UDI	Class II	Unknown
Verza Guidance System	644-096	FDA UDI	Class II	Active
GE Ultra-Pro II Biopsy Starter Kit	H40482LP	EUDAMEDFDA UDI	Class II	Active
Biopsy Starter Kit	698-006	FDA UDI	Class II	Active
Transducer Cover	610-2425	FDA UDI	Class II	Active
Needle Guide Bracket	676-243	FDA UDI	Class II	Active
Needle Guide	H40462LB	FDA UDI	Class II	Active
Multi-Purpose Workstation Stepper	627-042	FDA UDI	Class II	Active
eTRAX™ Needle	610-1806-10	FDA UDI	Class II	Unknown
Needle Guide	676-132	FDA UDI	Class II	Active
Biopsy Starter Kit	698-013	FDA UDI	Class II	Active
Needle Guide Starter Kit	11654277	EUDAMEDFDA UDI	Class II	Active
Biopsy Bracket	680-169	FDA UDI	Class II	Active
System Drape	610-870, H46222LS	FDA UDI	Class II	Active
Needle Guide	H42742LJ, 742-428	FDA UDI	Class II	Active
Needle Guide	614-079	FDA UDI	Class II	Active
Ultra-Pro e™ Variable Angle Needle Guide	610-1135	FDA UDI	Class II	Unknown
Tracking Bracket Starter Kit	10441190	FDA UDI	Class II	Active
Biopsy Bracket	614-063	FDA UDI	Class II	Unknown
Verza Guidance System	639-060	FDA UDI	Class II	Active
Biopsy Bracket	658-005	FDA UDI	Class II	Active
Biopsy Bracket	610-888	FDA UDI	Class II	Active
Biopsy Starter Kit	680-105	FDA UDI	Class II	Active
GE Reusable Endocavity Needle Guide	5776036	FDA UDI	Class II	Active
CIV-Flex™ Guide Sheath	SH-01	EUDAMEDFDA UDI	Class II	Active
Needle Guide	677-057	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

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.

CIVCO MEDICAL INSTRUMENTS CO., INC. has 53 recall records initiated between 2008-01-16 and 2026-03-02, with statuses recorded as open, classified, and terminated. The reasons for recalls include incorrect needle guides, potential puncture of sterile covers, inadequate adhesive assembly, reversed scale displays, incorrect calibration of electromagnetic sensors, leaks compromising sterility, misaligned scales, mislabeled masks, pinhole breaches in transducer covers, improper polyethylene treatment, non-sterile covers labeled as sterile, and incorrect localization moves.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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).