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File-Eze

ULTRADENT PRODUCTS, INC. · Model S127-CE · UDI-DI 00883205019356

KJJ Prescription
1
510(k) clearances
24
Adverse events
7
Recalls
35
Facilities

Description

Sample File-Eze CE

Recalls

DateFirmReason
2019-06-27Inter-Med LlcThe 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
2019-06-27Inter-Med LlcThe 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
2019-06-27Inter-Med LlcThe 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
2019-06-27Inter-Med LlcThe 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
2019-06-27Inter-Med LlcThe 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
2019-06-27Inter-Med LlcThe 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
2019-06-27Inter-Med LlcThe 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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Data 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.