UNIMAX MEDICAL SYSTEMS INC
FDA Regulatory Profile
UNIMAX MEDICAL SYSTEMS INC appears in FDA public data with 1 recall, 7 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-3164-2024, Class II) was initiated on June 25, 2024. Its most recent 510(k) clearance was granted on November 5, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3164-2024 | Class II | 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. | June 25, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211577 | SoftFix Balloon Trocar | November 5, 2021 |
| K103508 | UNMIAX LAPAROSCOPIC INSTRUMENT | December 20, 2011 |
| K112358 | UNIMAX TROCAR SYSTEM | October 17, 2011 |
| K111622 | UNIMAX ANTI-FOG SOLUTION | September 9, 2011 |
| K111441 | UNIMAX VERESS NEEDLE | August 19, 2011 |
| K103509 | UNIMAX SUCTION IRRIGATION SET | May 19, 2011 |
| K103510 | UNIMAX SPECIMEN RETRIEVAL SYSTEM | May 6, 2011 |