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ELMED
ELMED INCORPORATED · Model 115 515/715-100 · UDI-DI 00842180147768
FRK
Prescription
4
510(k) clearances
652
Adverse events (1 deaths)
1
Recalls
69
Facilities
Description
COMPLETE FOOTSWITCH FOR URO 2000 MODEL 515/715 (WITHOUT CONNECTING CABLE)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden |
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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.