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ELMED INCORPORATED
ELMED INCORPORATED · Model ST322316IM · UDI-DI 00198506068898
HDF
Prescription
10
510(k) clearances
44
Adverse events
3
Recalls
227
Facilities
Description
INSULATED COMPACT WEIGHTED “E” VAGINAL SPECULUM, 2 1/2” LBS, 3 3/4” X 1 1/2” BLADE SIZE, 11" OVERALL LENGTH, WITH SLOTTED SMOKE TUBE FOR DISPOSABLE EVACUATION TUBE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2023-03-16 | Carefusion 2200 Inc | A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products. |
| 2019-07-01 | Centurion Medical Products Corporation | Potential for sterile packaging to be compromised |
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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.