Shape Medical Systems, Inc
Shape Medical Systems, Inc appears in FDA public data with 2 recalls, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1060-2015, Class II) was initiated on December 23, 2014. Its most recent 510(k) clearance was granted on January 21, 2016.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1060-2015 | Class II | Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. | December 23, 2014 |
| Z-2051-2014 | Class II | Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable | May 28, 2014 |