Home › WISC MED, LLC › WiscMed
WiscMed
WISC MED, LLC · Model spec1-300 · UDI-DI 00850009819017
10
510(k) clearances
10
Adverse events
2
Recalls
231
Facilities
Description
A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the WiscMed Wispr digital otoscope. This item number consists of a quantity of 300 specula, packaged in plastic sleeves designed to fit traditional wall mounted specula holders found in most patient exam rooms.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.