Data / Medical devices / United States / Alden Medical LLC
Alden Medical LLC: FDA-registered device maker in W Springfield, MA, United States, 1 510(k) clearance
Alden Medical LLC is registered with the FDA (registration 1221361) in W Springfield, MA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 30, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221361
- Address
- 360 Cold Spring Ave, W Springfield, MA, United States, 01089
- Owner or operator
- ALDEN MEDICAL LLC (9064620)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Aldahol 1.8, Compat, Compliance, Metricide OPA Plus, Micro-X, PerAldecide, Peracidin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Contract manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Contract manufacturer | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 30, 2012 | K113015 | ALDAHOL V HIGH LEVEL DISINFECTANT | MED | Substantially Equivalent | Microchem Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Sterilant, Medical Devices
- All makers of Calibrator, Secondary
Updated January 30, 2012. 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.