Data / Medical devices / Stool, Operating-Room / United States
FDA-registered makers of Stool, Operating-Room in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Stool, Operating-Room (product code FZM). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Stool, Operating-Room
- Product code
- FZM
- Country
- United States
Makers of Stool, Operating-Room in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apramed USA LLC | Kissimmee, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Casco Manufacturing Solutions, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GF Health Products, Inc | Atlanta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intensa, Inc. | High Point, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Technology Industries, Inc. | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mid Central Medical | Saint Vincent, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reina Imaging | Crystal Lake, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smart Step Surgical, LLC | Billings, MT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Medical | Portage, MI, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Summit Dental Systems LLC. | Fort Lauderdale, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Brewer Company LLC | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.