Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Custom Ultrasonics with 6 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Mar 30, 2020: System 83 Plus Washer/Disinfector.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 30, 2020 | System 83 Plus Washer/DisinfectorK173590 · FEB | 510(k) clearances |
| Apr 28, 2017 | Scope-Assist Flushing SinkK162120 · FEB | 510(k) clearances |
| May 6, 2016 | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes thClass II · To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level di | Device recalls |
| Mar 12, 2013 | Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.Class II · Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prio | Device recalls |
| Jan 25, 2013 | SYSTEM 83 PLUSK122172 · FEB | 510(k) clearances |
| Jan 12, 2007 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTORK061430 · FEB | 510(k) clearances |
| Sep 22, 1998 | MODIFICATION TO SYSTEM 83 PLUSK983017 · NVE | 510(k) clearances |
| Nov 28, 1984 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2K842754 · FLG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
