FDA Registration
Active
🇺🇸 United States
L&R USA INC.
Reg #: 2135152
·
FEI: 3008162665
·
Expires 2026
Products
36
Proprietary Names
55
Establishment Types
5
Classifications
36
Registration Details
- Registration Name
- L&R USA INC.
- Registration Number
- 2135152
- FEI Number
- 3008162665
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3880 West Wheelhouse Road
- City
- Milwaukee
- State
- WI
- ZIP
- 53208
- Country
- US
Regulatory Submissions
- 510(k) Number
- K024054
Owner / Operator
- Firm Name
- L&R USA INC.
- Operator Number
- 9040291
- Address
- 3880 W Wheelhouse Road
- City
- Milwaukee
- State
- WI
- Postal Code
- 53208
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2001-06-08 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2018-01-12 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2017-06-19 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2016-01-14 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2016-01-14 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2016-01-14 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2016-01-14 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2017-06-19 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2017-06-19 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2016-01-14 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2021-01-07 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2016-01-14 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2016-01-14 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2013-01-21 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2016-01-14 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2016-01-14 |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 2016-01-14 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2017-06-19 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2017-06-19 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2020-06-05 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2016-01-14 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-06-19 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2016-01-14 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2016-01-14 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2016-01-14 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2017-06-19 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2017-06-19 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2016-01-14 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2000-02-04 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-07-06 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2018-01-12 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2001-06-08 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2016-01-14 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2021-06-25 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2017-06-19 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2002-06-19 |
Proprietary Names
JOINTJACKET
Debrisoft
Debrisoft Duo
EPX
Cellacare
Mom-EZ
BioCol
DAUERBINDE
Rosidal CC
IDEALBINDE
TG
ROSIDAL K
MOLLELAST
LENKELAST
Rosidal TCS
Rosidal Soft
Rosidal SC
LoFore
Raucolast
ACOLS Kit
SwiftBand
Suprasorb P Sensitive Ag Border
BioPad
Suprasorb P Sensitive Ag Non-Border
Komprex products
SWELLSPOTS
CerviCare
Debrisoft Lolly
CARESIA
READYWRAP
TRIBUTEWRAP
THERAFIT
EXO
TRIBUTENIGHT
TributeWrap Sleep Sleeve
ReadyWrap Fusion Kit
Tribute Freedom
Suprasorb A products
Suprasorb P products
Metallline Products
Vliwasorb
Flivasorb
Zorflex
ReadyWrap Liner
ReadyWrap Fusion Liner
Venosan 3000
Venosan 4000
Venosan 6000
Venosan Athletic
Venosan Silk Support
Venosan Jet Legs
Venosan Sheer Secrets
Venosan Cotton Support
Venosan 5000
Venosan Siliverline
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device