Allen Medical Systems

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1262-2018Class IIF-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used tFebruary 21, 2018
Z-0642-2018Class IIRadiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spOctober 6, 2017
Z-0641-2018Class IIAllen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spineOctober 6, 2017
Z-1198-2017Class IIArthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex LateralJanuary 3, 2017
Z-0928-2017Class IIArthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between MarcNovember 23, 2016
Z-0959-2013Class IIAllen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg February 28, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K971988ALLEN, ULTRA AND SMART SOCKETSJuly 11, 1997
K964273DURA-BOARD ARMBOARDJanuary 8, 1997
K960027HIGH VOLUME I.V. & IRRIGATION TOWERMarch 12, 1996
K944779CARBON LIGHTS HAND SURGERY TABLEOctober 14, 1994
K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000April 21, 1993