Fetzer Medical GmbH & Co. KG
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0758-2019 | Class II | 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 | December 28, 2018 |
| Z-0755-2019 | Class II | 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 F | December 28, 2018 |
| Z-0757-2019 | Class II | 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetz | December 28, 2018 |
| Z-0756-2019 | Class II | 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 | December 28, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172661 | Fetzer Medical Gynecological Forceps | May 8, 2018 |
| K163524 | Vessel Dilator | June 29, 2017 |
| K161004 | Self-retaining Retractor | September 9, 2016 |