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ELMED
ELMED INCORPORATED · Model 37400-130 · UDI-DI 00842180172333
LRC
Prescription
10
510(k) clearances
561
Adverse events (13 deaths)
5
Recalls
219
Facilities
Description
4MM, 30 DEG., VIEWING, ELMED ES ECONOMY SINUS SCOPE WITH STORZ TYPE SLEEVE LOCK, PREMIUM AMERICAN MADE OPTICAL LENS SYSTEM, STANDARD TYPE ACMI LIGHT POST WITH WOLF AND STORZ ADAPTER, FULLY AUTOCLAVABLE.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. |
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
| 2013-05-24 | Gyrus Acmi, Incorporated | lack of sterility assurance |
| 2006-01-20 | Acclarent Inc | Device sterility may be compromised as evidenced by a loss of package integrity. |
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