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Sigmoidoscope And Accessories, Flexible/Rigid
FDA product code FAM · Class 2 · Gastroenterology, Urology
25
Registered devices
54
Adverse events
2
Recalls
24
510(k) clearances
Devices with this code
VIDEO SIGMOIDOSCOPE — PENTAX OF AMERICA, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.FUJIFILM — FUJIFILM CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.FUJIFILM — FUJIFILM CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.PENTAX — HOYA CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.n.a. — Karl Storz GmbH & Co. KGVIDEO SIGMOIDOSCOPE — PENTAX OF AMERICA, INC.PENTAX — HOYA CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.PENTAX — HOYA CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.PENTAX — HOYA CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-06 | Pentax Medical Company | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with t |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's |
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