ArjoHuntleigh Inc.
FDA Regulatory Profile
ArjoHuntleigh Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0926-2014, Class II) was initiated on September 11, 2013. Its most recent 510(k) clearance was granted on July 6, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0926-2014 | Class II | The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of | September 11, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110994 | PARKER 500 | July 6, 2011 |