FDA Registration
Active
🇺🇸 United States
CLINICAL INNOVATIONS, LLC
Reg #: 1722684
·
FEI: 1000220650
·
Expires 2026
Products
15
Proprietary Names
18
Establishment Types
4
Classifications
15
Registration Details
- Registration Name
- CLINICAL INNOVATIONS, LLC
- Registration Number
- 1722684
- FEI Number
- 1000220650
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 747 W 4170 S
- City
- MURRAY
- State
- UT
- ZIP
- 84123
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250298
Owner / Operator
- Firm Name
- Clinical Innovations, LLC
- Operator Number
- 10035300
- Address
- 747 W 4170 S
- City
- Murray
- State
- UT
- Postal Code
- 84123
- Country
- US
- Correspondent
- Nicole Boser
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Extractor, Vacuum, Fetal | HDB | Class 2 | Obstetrics/Gynecology | No | 2025-12-09 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2025-05-14 |
| Transducer, Pressure, Intrauterine | HFN | Class 2 | Obstetrics/Gynecology | No | 2025-06-09 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2020-12-04 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2015-01-14 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2011-02-17 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2011-02-17 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2023-03-08 |
| Dynamic Rectal Control System | PJH | Class 2 | Gastroenterology, Urology | No | 2022-05-24 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2011-02-17 |
| Immunoassay For Detection Of Amniotic Fluid Protein(S). | NQM | Class 1 | Clinical Chemistry | No | 2012-04-30 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-04-30 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-12-07 |
| Monitor, Uterine Contraction, External (For Use In Clinic) | HFM | Class 2 | Obstetrics/Gynecology | No | 2014-07-28 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2011-02-17 |
Proprietary Names
Kiwi Complete Vacuum Delivery System
LifeBubble
Koala Intrauterine Pressure Catheter
Koala
BoogieBaby
Kiwi
Traxi Panniculus Retractor
Clearview Uterine Manipulator
AccuCirc
babyLance
Eclipse System
AIR-CHARGED CATHETERS
ROM Plus Fetal Membranes Rupture Test
ABBy Postoperative Panniculus Retractor
Koala Toco
ClearView Total
Spiral Fetal Scalp Electrode
Reusable Cables (accessories)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)