Allen Medical Systems
FDA Regulatory Profile
Allen Medical Systems appears in FDA public data with 6 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1262-2018, Class II) was initiated on February 21, 2018. Its most recent 510(k) clearance was granted on July 11, 1997.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1262-2018 | Class II | F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used t | February 21, 2018 |
| Z-0642-2018 | Class II | Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar sp | October 6, 2017 |
| Z-0641-2018 | Class II | Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine | October 6, 2017 |
| Z-1198-2017 | Class II | Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral | January 3, 2017 |
| Z-0928-2017 | Class II | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between Marc | November 23, 2016 |
| Z-0959-2013 | Class II | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg | February 28, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K971988 | ALLEN, ULTRA AND SMART SOCKETS | July 11, 1997 |
| K964273 | DURA-BOARD ARMBOARD | January 8, 1997 |
| K960027 | HIGH VOLUME I.V. & IRRIGATION TOWER | March 12, 1996 |
| K944779 | CARBON LIGHTS HAND SURGERY TABLE | October 14, 1994 |
| K921168 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 | April 21, 1993 |