Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
Similar devices
- "LAMIS ""Y"" Tubing" MENTOR TEXAS L.P.
- 5F Axcess Percutaneous Catheter Introducer Kit ARGON MEDICAL DEVICES, INC.
- 7F Axcess Percutaneous Catheter Introducer Kit ARGON MEDICAL DEVICES, INC.
- 7F One Piece Introducer Kit ARGON MEDICAL DEVICES, INC.
- ACE ACE SURGICAL SUPPLY CO., INC.
- ACE ACE SURGICAL SUPPLY CO., INC.
- ACE ACE SURGICAL SUPPLY CO., INC.
- AESCULAP Aesculap AG
- AMSure® Single Spike Infiltration Tubing AMSINO INTERNATIONAL, INC.
- ARGYLE Cardinal Health, Inc.
- ARGYLE Cardinal Health, Inc.
- ARROW TELEFLEX INCORPORATED
Select up to two to place side-by-side with this device.