Data / Medical devices / Unit, Examining/Treatment, Ent
Unit, Examining/Treatment, Ent (ETF): 16 FDA-registered makers in 7 countries
16 establishments in 7 countries are registered with the FDA to make Unit, Examining/Treatment, Ent (product code ETF, Class 1, 21 CFR 874.5300). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on August 11, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ETF
- Device class
- 1
- Regulation
- 874.5300
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 4 |
| China | 1 |
| India | 1 |
| Mexico | 1 |
| South Korea | 1 |
| Spain | 1 |
Makers of Unit, Examining/Treatment, Ent
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atmos Medizintechnik GMBH & Co. KG | LENZKIRCH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boyd Industries, Inc. | Clearwater, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haag-Streit Usa, Inc. | Mason, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happersberger Otopront GMBH | Hohenstein Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JEDMED Instrument Company | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M.I.One Co.,Ltd. | Wonju-si Gangwon, South Korea | 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 | |
| Optomic Espana, S.A. | COLMENAR VIEJO Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical | Philadelphia, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Specialties Co., Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 11, 1995. 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.