Device recall event
Recall event 97879: Edan Diagnostics
FDA device recall · Class II · Open, Classified
Key facts
| Recall event number | 97879 |
|---|---|
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K101539, K102140, K113623, K113653, K120727, K131818, K131971, K150901, K152552, K160981, K161056, K171178 and 8 more |
At a glance
- 10–99 Recalled products (Z-numbers)
- 10–99 Linked 510(k)s
- 1–9 Recall events for this firm
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall events
A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database