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ELMED

ELMED INCORPORATED · Model 32-5004-I · UDI-DI 00842180179196

HDQ Prescription

510(k) clearances

Adverse events

Recalls

153

Facilities

Description

(A) 1 1/2" (3.8CM) DIA., X (B) 11 3/4"(30CM) OVERALL LENGTH. STAINLESS STEEL INSULATED ON- CONDUCTIVE VAGINAL DILATOR, WITH SMOOTH CURVED TIP FOR COMFORTABLE INSERTION AND BASE WITH GROOVES ON HANDLE FOR ANTI-SLIP CONTROL. (

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.
2009-04-09	Marina Medical Instruments Inc.	Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was
2009-04-09	Marina Medical Instruments Inc.	Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not p

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Data 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.