Data / Medical devices / United States / L&R Usa Inc.
L&R Usa Inc.: FDA-registered device maker in Milwaukee, WI, United States, 10 510(k) clearances
L&R Usa Inc. is registered with the FDA (registration 2135152) in Milwaukee, WI, United States. It lists 36 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2135152
- FEI number
- 3008162665
- Address
- 3880 West Wheelhouse Road, Milwaukee, WI, United States, 53208
- Owner or operator
- L&R USA INC. (9040291)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 4, 2000
- Registered through
- 2026
- Brand names listed
- ACOLS Kit, BioCol, BioPad, CARESIA, Cellacare, CerviCare, DAUERBINDE, Debrisoft and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 21, 2024 | K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch | FRO | Substantially Equivalent | Speciality Fibres and Materials, Ltd. | accessdata.fda.gov |
| March 30, 2017 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| August 17, 2016 | K160022 | LUOFUCON Silicone Ag foam dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 1, 2008 | K071442 | SUPRASORB A +AG | FRO | Substantially Equivalent | Specialty Fibres and Materials, Ltd. | accessdata.fda.gov |
| July 22, 2005 | K040283 | BIOPAD | QSY | Substantially Equivalent | Euroresearch Srl | accessdata.fda.gov |
| August 9, 2004 | K030774 | STIMULEN COLLAGEN | KGN | Substantially Equivalent | Southwest Technologies, Inc. | accessdata.fda.gov |
| March 7, 2003 | K024054 | XYLOS XCELL ANTIMICROBIAL DRESSING | MGQ | Substantially Equivalent | Xylos Corporation | accessdata.fda.gov |
| June 22, 1998 | K974251 | X-CELL WOUND DRESSING | MGQ | Substantially Equivalent | Xylos Corporation | accessdata.fda.gov |
| December 22, 1980 | K802794 | PRO-OPHTA STICKS | HOZ | Substantially Equivalent | Secol Co. | accessdata.fda.gov |
| December 17, 1980 | K802791 | ZINC PASTE BANDAGE | FRO | Substantially Equivalent | Secol Co. | accessdata.fda.gov |
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Updated October 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.