FDA Registration
Active
🇺🇸 United States
ADVANCED CONCEPT INNOVATIONS LLC
Reg #: 3006015326
·
FEI: 3006015326
·
Expires 2026
Products
20
Proprietary Names
41
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- ADVANCED CONCEPT INNOVATIONS LLC
- Registration Number
- 3006015326
- FEI Number
- 3006015326
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4100 S. FRONTAGE RD., Suite 104
- City
- LAKELAND
- State
- FL
- ZIP
- 33815
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062638
- PMA Number
- P040045
Owner / Operator
- Firm Name
- ADVANCED CONCEPT INNOVATIONS LLC
- Operator Number
- 9094662
- Address
- 4100 S. FRONTAGE RD., ste 104
- City
- Lakeland
- State
- FL
- Postal Code
- 33815
- Country
- US
- Correspondent
- Matthew Muller
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2012-02-03 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2015-09-14 |
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2016-05-19 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-12-22 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-12-22 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2016-05-19 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2015-09-18 |
| Pad, Menstrual, Scented, Scented-Deodorized | HHL | Class 2 | Obstetrics/Gynecology | No | 2015-09-14 |
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | Class 2 | Obstetrics/Gynecology | No | 2015-09-14 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2021-12-22 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2014-09-05 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2014-09-05 |
| Nursing Pad, Cohesive Gel | NXH | Class 1 | General Hospital | No | 2015-09-11 |
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2016-05-19 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2021-05-21 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2015-09-11 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2022-08-10 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2021-12-22 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | Class 1 | Obstetrics/Gynecology | No | 2015-09-11 |
| Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | KOO | Class 1 | Dental | No | 2022-09-13 |
Proprietary Names
Tampon, Menstrual, Unscented
SUREVUE
ACUVUE CLEAR
ACUVUE
ACUVUE 3
Freedom Knee
ACUVUE BIFOCAL
1-DAY ACUVUE MOIST (MULTIFOCAL)
ACUVUE ADVANCE
ACUVUE ADVANCE PLUS
ACUVUE ADVANCE for ASTIGMATISM
Always Discreet
Pads, Scented Menstrual
Tampon, Menstrual, Scented, Deodorized
ACUVUE 2 DEFINE
ACUVUE 2 COLOURS
1-DAY ACUVUE DEFINE
NBX - NON BRIDGING EXTERNAL FIXATOR HAND
The Freedom Total Knee System
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
Nipple Shield
ACUVUE OASYS
ACUVUE OASYS for ASTIGMATISM
ACUVUE OASYS for PRESBYOPIA
NBX - NON BRIDGING EXTERNAL FIXATOR WRIST
ACI Surgical N95 Respirator
Feminine Pads
ACUVUE OASYS with HydraLuxe
1-DAY ACUVUE DEFINE with LACREON
1-DAY ACUVUE MOIST
1-DAY ACUVUE MOIST with LACREON
1-DAY ACUVUE MOIST for ASTIGMATISM
1-DAY ACUVUE MOIST for ASTIGMATISM with LACREON
SiteSeal Femoral Compression Device
1-DAY ACUVUE TruEye (narafilcon A)
Fixodent
ACUVUE 2
1-DAY ACUVUE TruEye (narafilcon B)
1-DAY ACUVUE for ASTIGMATISM
1-DAY ACUVUE EasyGo
1-DAY ACUVUE
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device