Healthium Medtech Limited
Healthium Medtech Limited appears in FDA public data with 0 recalls, 5 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent FDA inspection ended on Apr 29, 2016 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Jan 4, 2024.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 1
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 29, 2016 | Bangalore, India | Devices | Voluntary Action Indicated (VAI) | 3004944585 |
| Dec 20, 2012 | Bangalore, India | Devices | Voluntary Action Indicated (VAI) | 3004944585 |
| Apr 23, 2010 | Bangalore, India | Devices | Official Action Indicated (OAI) | 3004944585 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Jan 4, 2024 |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | Dec 28, 2023 |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Nov 8, 2023 |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop… | Aug 4, 2023 |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | Mar 22, 2023 |