Data / Medical devices / Mexico / ASO AMERICAS, S. de R. L. de C. V.
ASO AMERICAS, S. de R. L. de C. V.: FDA-registered device maker in JUAREZ Chihuahua, Mexico, 9 510(k) clearances
ASO AMERICAS, S. de R. L. de C. V. is registered with the FDA (registration 3005761322) in JUAREZ Chihuahua, Mexico. It lists 23 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 25, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005761322
- Address
- CENTRO INDUSTRIAL JUAREZ, RIO MICHIGAN No. 9730, JUAREZ Chihuahua, Mexico, 32648
- Owner or operator
- ASO LLC (1038758)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 8, 1988
- Registered through
- 2027
- Brand names listed
- DRESSING, WOUND, HYDROPHILIC, Tender Tape
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 25, 2019 | K192667 | gel-e Flex+ gel OTC | QSY | Substantially Equivalent | Gel-E, Inc. | accessdata.fda.gov |
| September 11, 2017 | K171317 | Clear Vinyl Powder-free Patient Examination Gloves | LYZ | Substantially Equivalent | Shandong Zhi Hong Medical Products, Co. , Ltd. | accessdata.fda.gov |
| October 16, 2012 | K121992 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | LZA | Substantially Equivalent | Xinwei (Shandong) Plastic and Rubber Products Co., | accessdata.fda.gov |
| August 3, 2012 | K121526 | POWER-FREE NITRILE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Shandong Junchi Medical Products Co., Ltd. | accessdata.fda.gov |
| November 22, 2010 | K102444 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Yingbo Medical Products, Inc. | accessdata.fda.gov |
| September 14, 2007 | K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| September 12, 2007 | K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| February 17, 1999 | K983368 | CARE BAND ANTIBACTERIAL BANDAGES | KGX | Substantially Equivalent | Aso Corp. | accessdata.fda.gov |
| January 29, 1988 | K874813 | OMED WOUND CLOSURE STRIPS | FPX | Substantially Equivalent | Oxboro Medical Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Fiber, Medical, Absorbent
- All makers of Vinyl Patient Examination Glove
- All makers of Forceps, General & Plastic Surgery
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Updated October 25, 2019. 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.