483
Zyno Medical LLCZyno Medical LLC – FDA 483, Sep 18, 2025
Record Details
Zyno Medical LLC, a medical device manufacturer in Natick, MA, received a Form FDA 483 with one repeat observation. The firm failed to submit 60 Medical Device Reports (MDRs) within the required 30-day timeframe, indicating a significant issue with their reporting procedures for device malfunctions. This is a repeat observation, highlighting a persistent compliance problem.
- Person
View Company Profile
ID · 465d5a17-4f0b-47b1-af1f-dbc2133882d3
Other documents for Zyno Medical LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.