BrosMed Medical Co.,Ltd. FDA Record
- Latest inspection NAI · Apr 26, 2018
- No warning letters matched by name
BrosMed Medical Co.,Ltd. has 1 FDA recall, 1 inspection, 10 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "BrosMed Medical Co.,Ltd." is on file.
- Latest recall
- Z-0963-2019 · Class II · Dec 14, 2018
- Latest inspection
- Apr 26, 2018 · NAI
- Latest 510(k)
- Feb 27, 2025
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 10 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0963-2019 | Class II | Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate… | Dec 14, 2018 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 26, 2018 | Dongguan, China | Devices | No Action Indicated (NAI) | 3010391265 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010391265 | Dongguan, China | 1 | Apr 26, 2018 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter… | Feb 27, 2025 |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Oct 22, 2024 |
| K230705 | POT PTCA Balloon Dilatation Catheter | Apr 11, 2023 |
| K212215 | Tiche PTA Balloon Dilatation Catheter | Jul 19, 2022 |
| K203390 | Artimes pro Balloon Dilatation Catheter | Apr 14, 2021 |
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | Dec 13, 2016 |
| K153742 | Apollo Balloon Dilatation Catheter | Aug 8, 2016 |
| K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Jul 29, 2016 |
| K133852 | APOLLO BALLOON DILATATION CATHETER | Sep 19, 2014 |
| K141025 | ARTIMES BALLOON DILATATION CATHETER | Sep 12, 2014 |
BrosMed Medical Co.,Ltd. and the FDA: common questions
Has BrosMed Medical Co.,Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "BrosMed Medical Co.,Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has BrosMed Medical Co.,Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "BrosMed Medical Co.,Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect BrosMed Medical Co.,Ltd.?
The most recent FDA inspection on file ended Apr 26, 2018 at Dongguan, China and was classified NAI. FDA has 1 inspection of BrosMed Medical Co.,Ltd. on file.
Has BrosMed Medical Co.,Ltd. had an FDA recall?
Yes. BrosMed Medical Co.,Ltd. has 1 FDA recall on record. The most recent started Dec 14, 2018.
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