FDA Registration
Active
🇺🇸 United States
CIVCO Medical Instruments Co., Inc.
Reg #: 3034286426
·
FEI: 1937223
·
Expires 2026
Products
15
Proprietary Names
50
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- CIVCO Medical Instruments Co., Inc.
- Registration Number
- 3034286426
- FEI Number
- 1937223
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 750 Lois Lane
- City
- Coralville
- State
- IA
- ZIP
- 52241
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091022
Owner / Operator
- Firm Name
- CIVCO Medical Instruments Co., Inc.
- Operator Number
- 1937223
- Address
- 750 Lois Lane, --
- City
- Coralville
- State
- IA
- Postal Code
- 52241
- Country
- US
- Correspondent
- JIM - LEONG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2022-08-23 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2016-09-22 |
| Cabinet, Instrument, Ac-Powered, Ophthalmic | HRE | Class 1 | Ophthalmic | No | 2016-11-21 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2022-08-23 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 1987-08-13 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2015-02-03 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2005-07-26 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-03-05 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2013-12-17 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2013-12-17 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2023-11-28 |
| High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | PSW | Class 2 | Radiology | No | 2016-11-21 |
| Endoscope Maintenance System | PUP | Class 2 | Gastroenterology, Urology | No | 2026-03-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2014-04-08 |
| Basin For Endoscope Reprocessing | PHT | Class 1 | Gastroenterology, Urology | No | 2016-05-12 |
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
VitroPRO
TP Pivot Pro
GUS ASTRA TEE Transesophageal Probe Reprocessor
GUS ASTRA VR Endovaginal/Endorectal Probe Reprocesor
CIVCO Storage System
CT Extension Handle
RAD guide
Endocavity Transducer Soaking System
CIVCO ENDOCAVITY ULTRASOUND
Brachyballoon standoff
eTRAX Needle System
ViruTRAX Instrument Navigator
Active Fiducial Marker
EMT System
General Purpose Sensor
eTRAX Variable Angle Needle Guide
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility