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econom® XL 2.5 V,
Rudolf Riester GmbH · Model 2052-201 · UDI-DI 04045396130609
1
510(k) clearances
10
Adverse events
2
Recalls
231
Facilities
Description
The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula The laryngeal mirrors are produced for mirroring or examination of the oral cavity and pharynx in combination with the Riester bent-arm illuminator. The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. The nasal speculum is produced for illumination and therefore examination of the inside of the nose. The blade holder is produced for examination of the oral cavity and pharynx in combination with commercial wooden
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.