Home › Davol Inc. › HEMADERM
HEMADERM
Davol Inc. · Model ENT0001-2 · UDI-DI 00801741044083
1
510(k) clearances
178
Adverse events
15
Recalls
35
Facilities
Description
ENT Kit with HEMADERM, (Contents: 1) 2g bellows container and (Contents: 2) ENT Applicators
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
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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.