Total clearances
3
2022-04-20 → 2024-01-28
Name variants in FDA filings: Synovis Micro Companies Alliance / Synovis Micro Companies Alliance, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| IYN |
System, Imaging, Pulsed Doppler, Ultrasonic |
Class II |
Radiology |
1 |
2024-01-28 |
| DXC |
Clamp, Vascular |
Class II |
Cardiovascular |
1 |
2022-09-14 |
| DPW |
Flowmeter, Blood, Cardiovascular |
Class II |
Cardiovascular |
1 |
2022-04-20 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-01-28 |
K233394 |
Gem Flow Now (GEM2770-FN) |
IYN |
Class II |
Radiology |
| 2022-09-14 |
K221843 |
GEM Biover Microvascular Clamps |
DXC |
Class II |
Cardiovascular |
| 2022-04-20 |
K213974 |
GEM FLOW COUPLER Monitor (GEM1020M-2) |
DPW |
Class II |
Cardiovascular |