Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2135152

FEI Number

3008162665

Entity Name

L&R USA INC.

City/State/Country

Milwaukee, WI, US

Establishment Address

3880 West Wheelhouse Road, Milwaukee, WI 53208, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

L&R USA INC. (Owner Number: 9040291)

Owner / Operator Contact Address

3880 W Wheelhouse Road, Milwaukee, WI 53208, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2001-06-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-01-12
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2017-06-19
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2016-01-14
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2016-01-14
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2016-01-14
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2016-01-14
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2017-06-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-06-19
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2016-01-14
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-01-07
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-01-14
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-01-14
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-01-21
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2017-06-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-07-01
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	Class 1	890.3420	2016-01-14
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2016-01-14
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2016-01-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-06-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2017-06-19
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2017-06-19
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2020-06-05
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2016-01-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-06-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-07-01
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2016-01-14
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2016-01-14
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-01-14
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2017-06-19
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-06-19
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2016-01-14
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2000-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

L&R USA 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
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2135152. Last updated year: 2026. Please use registration number 2135152 when referencing this establishment in official correspondence.