Company ยท US
Allen Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1997. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HST | Apparatus, Traction, Non-Powered | 3 |
| CCX | Support, Patient Position | 2 |
| FQO | Table, Operating-Room, Ac-Powered | 2 |
| FWZ | Operating Room Accessories Table Tray | 2 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | 2 |
| FOX | Stand, Infusion | 1 |
| GDC | Table, Operating-Room, Electrical | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 |
| N/A | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 1997 | K971988 | ALLEN, ULTRA AND SMART SOCKETS Allen Medical Systems, Inc. | FQO |
| Jan 8, 1997 | K964273 | DURA-BOARD ARMBOARD Allen Medical Systems, Inc. | GDC |
| Mar 12, 1996 | K960027 | HIGH VOLUME I.V. & IRRIGATION TOWER Allen Medical Systems, Inc. | FOX |
| Oct 14, 1994 | K944779 | CARBON LIGHTS HAND SURGERY TABLE Allen Medical Systems, Inc. | FWZ |
| Apr 21, 1993 | K921168 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 Allen Medical Systems, Inc. | KZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2018 | Allen Medical Systems F-T3SYSTEM, T3 (Trumpf Table Top) System
The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top fr Terminated |
N/A | None listed |
| Oct 6, 2017 | Allen Medical Systems Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures. Terminated |
JEB | None listed |
| Oct 6, 2017 | Allen Medical Systems Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures. Terminated |
JEB | None listed |
| Feb 14, 2017 | Allen Medical Systems, Inc. Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01
Product Usage:
The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shou Terminated |
HST | None listed |
| Nov 23, 2016 | Allen Medical Systems, Inc. Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016. Terminated |
HST | None listed |
| Mar 18, 2013 | Allen Medical Systems, Inc. Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinic Terminated |
HST | None listed |
| Jan 11, 2012 | Allen Medical Systems, Inc. Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery
Catalog Numbers: A-70700 and A-70701-2 Terminated |
CCX | None listed |
| Aug 20, 2008 | Allen Medical Systems, Inc. Allen Medical C-Flex, Polar Head Positioner
Catalog Number: A-70700-A1
Product is a medical device used to maintain the position of an anesthetized patient during surgery. Terminated |
CCX | None listed |
| Apr 22, 2005 | Allen Medical Systems Allen A-91000 Shoulder Positioner Terminated |
FWZ | None listed |
| Aug 7, 2004 | Allen Medical Systems Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table
Catalog No: MDTNA2 Terminated |
FQO | None listed |