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ELMED
ELMED INCORPORATED · Model EL-RH850 · UDI-DI 00842180179691
LRC
Prescription
10
510(k) clearances
563
Adverse events (13 deaths)
5
Recalls
220
Facilities
Description
Hamrick suction dissector and elevator. Blunt elevator blade with suction connector and obturator. Tubular, blunt end and fitting to connect with suction apparatus. Matte and mirror finish. Overall length 6-3/4in (17.2cm).
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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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.