Merz North America, Inc.
FDA Regulatory Profile
Merz North America, Inc. appears in FDA public data with 5 recalls, 1 510(k) clearance, 20 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0401-2021, Class II) was initiated on September 30, 2020. Its most recent 510(k) clearance was granted on November 29, 2017.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 20
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0401-2021 | Class II | COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical partic | September 30, 2020 |
| Z-2607-2016 | Class II | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Produc | May 20, 2016 |
| Z-0368-2016 | Class II | PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Mode | October 26, 2015 |
| Z-0367-2016 | Class II | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in | October 26, 2015 |
| Z-0366-2016 | Class II | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantatio | October 26, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172689 | DESCRIBE PFD Patch | November 29, 2017 |