Data / Medical devices / United States / Seiler Instrument & Mfg. Co.,Inc.
Seiler Instrument & Mfg. Co.,Inc.: FDA-registered device maker in Saint Louis, MO, United States, 1 510(k) clearance
Seiler Instrument & Mfg. Co.,Inc. is registered with the FDA (registration 1927430) in Saint Louis, MO, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 6, 2010. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1927430
- Address
- 3433 Tree Court Industrial Blvd, Saint Louis, MO, United States, 63122
- Owner or operator
- Seiler Instrument & Mfg. Co., Inc. (1927430)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 30, 1992
- Registered through
- 2026
- Brand names listed
- 3D Surgical Microscope, ALPHA AIR 3 DENTAL, ALPHA AIR 3 ENT, ALPHA AIR 6 DENTAL, ALPHA AIR 6 ENT, Evolution XR6, Evolution ZOOM, LED LOUPE LIGHT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | 2 | Manufacturer | accessdata.fda.gov |
| Lamps, Microscope | KEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Light, Microscope | IBJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Microscope, Surgical | EPT | 1 | 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 |
|---|---|---|---|---|---|---|
| August 6, 2010 | K101141 | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 | HEX | Substantially Equivalent | Seiler Precision Microscopes | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 1, 2017 | 79362 | Class II | Ongoing | Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat. | The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Microscope
- All makers of Loupe, Diagnostic/Surgical
- All makers of Colposcope (And Colpomicroscope)
- All makers of Microscope, Surgical
Updated August 6, 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.