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., part of BaxterLabelled by claude-sonnet-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 Allen Medical Systems with 6 device recalls and 5 510(k) clearances. The most recent is a device recall dated Jan 3, 2017: Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Art….
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.
| Jan 3, 2017 | Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intendClass II · During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and pote | Device recalls |
| Nov 23, 2016 | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.Class II · During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspensio | Device recalls |
| Feb 28, 2013 | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices deClass II · Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and a | Device recalls |
| Jul 11, 1997 | ALLEN, ULTRA AND SMART SOCKETSK971988 · FQO | 510(k) clearances |
| Jan 8, 1997 | DURA-BOARD ARMBOARDK964273 · GDC | 510(k) clearances |
| Mar 12, 1996 | HIGH VOLUME I.V. & IRRIGATION TOWERK960027 · FOX | 510(k) clearances |
| Oct 14, 1994 | CARBON LIGHTS HAND SURGERY TABLEK944779 · FWZ | 510(k) clearances |
| Apr 21, 1993 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000K921168 · KZD | 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
