Data / Medical devices / United States / Merlyn Associates, Inc.
Merlyn Associates, Inc.: FDA-registered device maker in Santa Ana, CA, United States, 1 510(k) clearance
Merlyn Associates, Inc. is registered with the FDA (registration 3005160810) in Santa Ana, CA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 18, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005160810
- Address
- 2850 South Harbor Blvd., Santa Ana, CA, United States, 92704
- Owner or operator
- MERLYN ASSOCIATES, INC. (9071259)
- Roles
- Complaint file establishment
- First device listed
- March 11, 2005
- Registered through
- 2026
- Brand names listed
- Disposable Air Cushion Face Mask, ENDOMASK ECLIPSE, ENDOMASK ELITE, ENDOMASK ESSENTIAL, ENDOTUBE ENDOTRACHEAL TUBES, Merlyn Reservoir, Merlyn Wound Drain, Oxygen Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Complaint file establishment | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Complaint file establishment | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Complaint file establishment | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Complaint file establishment | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| February 18, 2005 | K042683 | WELL LEAD ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Gas, Anesthetic
- All makers of Catheter, Irrigation
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Catheter And Tip, Suction
- All makers of Mask, Oxygen
Updated February 18, 2005. 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.