AZIYO BIOLOGICS
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0040-2020 | Class II | CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2 | August 21, 2019 |
| Z-0039-2020 | Class II | BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single | August 21, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope | June 15, 2020 |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope | October 21, 2019 |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) | November 15, 2018 |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope | October 25, 2017 |