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EdgeEndo®
US ENDODONTICS, LLC · Model 100818365020058 · UDI-DI 00818365029006
KJJ
Prescription
10
510(k) clearances
24
Adverse events
7
Recalls
35
Facilities
Description
EdgeIce™ 0
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
| 2019-06-27 | Inter-Med Llc | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and ex |
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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.