CIVCO Medical Instruments Co., Inc.

FDA Device Registration & Listing · Coralville, IA, US · Registration 3034286426

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3034286426
FEI Number
1937223
Entity Name
CIVCO Medical Instruments Co., Inc.
City/State/Country
Coralville, IA, US
Establishment Address
750 Lois Lane, Coralville, IA 52241, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
CIVCO Medical Instruments Co., Inc. (Owner Number: 1937223)
Owner / Operator Contact Address
750 Lois Lane, --, Coralville, IA 52241, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K163313
PMA Number
N/A

All Registered Proprietary Names

Verza Needle Guide VR Storage Cabinet TEE Storage Cabinet TRANSVAGINAL BIOPSY GUIDE PROcover omniTRAX(TM) Active Patient Tracker Envision Multi-Pro 2000 AccuSITE Maggi II Plus Ultra-Pro 3 Ultra-Pro II Infinity Neoguard CIVCO ULTRASOUND SNEATH TRANSDUCER COVER MULTI-PURPOSE HOLDER CIV-Clear Cover Thor LED Cover Brachystepper Brachystand Needle Guide Template Multi-Purpose Workstation Disposable Template Grid Classic Stepper EX3 Stepper Multi-Purpose Workstation LP Micro-Touch Multi-Purpose Workstation Stepper Micro-Touch LP L25 series needle guide Transrectal Guide Astra VR Astra TEE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2022-08-23
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-09-22
HRE Cabinet, Instrument, Ac-Powered, Ophthalmic Ophthalmic Class 1 886.1860 2016-11-21
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2022-08-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 1987-08-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2009-11-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-02-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-02-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-05-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2010-11-15
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2009-11-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 1989-09-14
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2005-07-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-09-15
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2026-03-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2009-11-16
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-12-17
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2013-12-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-12-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2009-09-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2009-11-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-12-19

Official Correspondent

JIM LEONG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CIVCO Medical Instruments Co., Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033381 Discus Dental, Inc. DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL 2004-01-27
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034286426. Last updated year: 2026. Please use registration number 3034286426 when referencing this establishment in official correspondence.
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