Data / Medical devices / Mexico / La Ada De Acuna, S. de. R. L. de C. V.
La Ada De Acuna, S. de. R. L. de C. V.: FDA-registered device maker in COL.EDUCATIVA,NOGALES Sonora, Mexico, 6 510(k) clearances
La Ada De Acuna, S. de. R. L. de C. V. is registered with the FDA (registration 3005997949) in COL.EDUCATIVA,NOGALES Sonora, Mexico. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 9, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005997949
- Address
- AV. HIDALGO No. 6 ESQ. BLVD. LUIS DONALDO COLOSIO, COL.EDUCATIVA,NOGALES Sonora, Mexico, 84093
- Owner or operator
- O&M Halyard, Inc. (10057479)
- Roles
- Manufacturer
- First device listed
- April 20, 2018
- Registered through
- 2026
- Brand names listed
- Anesthesia Breathing Circuit Kit (Adult & Pediatric), Back Table Covers, Equipment Covers, General Surgery Tray, HALYARD BASICS SURGICAL GOWN, HALYARD PROCEDURE GOWN, HALYARD ULTRA SURGICAL GOWN, Halyard Gown and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| November 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| March 19, 2010 | K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| March 25, 2009 | K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| September 3, 2008 | K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| November 12, 2003 | K033021 | KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS | DWJ | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| August 7, 1986 | K862801 | SPUNGUARD PLUS SURGICAL DRAPE | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Antimicrobial
- All makers of General Surgery Tray
- All makers of System, Thermal Regulating
- All makers of Anesthesia Breathing Circuit Kit (Adult & Pediatric)
- All makers of Drape, Surgical, Exempt
Updated November 9, 2010. 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.