Company ยท TW
Besmed Health Business Corp
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2024. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| BZH | Meter, Peak Flow, Spirometry | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 |
| IPF | Stimulator, Muscle, Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 2024 | K241339 | Besmed Bacterial Filter and HMEF Besmed Health Business Corp, TW | CAH |
| Jan 11, 2018 | K172804 | Besmed Peak Flow Meter Besmed Health Business Corp, TW | BZH |
| Apr 29, 2016 | K160112 | Besmed PEEP Valve Besmed Health Business Corp, TW | BYE |
| Jun 30, 2015 | K150591 | Besmed Reusable Jet Nebulizer Besmed Health Business Corp, TW | CAF |
| Feb 5, 2015 | K143150 | CO2 monitoring line with and without in-line filter Besmed Health Business Corp, TW | CCK |
| Sep 3, 2014 | K141355 | VOLUMETRIC INCENTIVE SPIROMETER Besmed Health Business Corporation, TW | BWF |
| Jun 19, 2014 | K140370 | DISPOSABLE PRESSURE MANOMETER Besmed Health Business Corp, TW | CAP |
| Apr 4, 2014 | K133873 | TRIBALL INCENTIVE SPIROMETER Besmed Health Business Corp, TW | BWF |
| Nov 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET Besmed Health Business Corp, TW | CAF |
| Nov 28, 2003 | K031374 | BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 Besmed Health Business Corp, TW | GZJ |
| Nov 20, 2003 | K031375 | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 Besmed Health Business Corp, TW | IPF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2018 | Besmed Health Business Corporation Ambu Aura40 Standard, Reusable Laryngeal Mask
Catalog Number: 340300000 Terminated |
CAE | None listed |