3B Medical, Inc.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0828-2025 | Class II | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Numbe | November 27, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K212263 | Luna G3 BPAP System | March 25, 2022 |
| K201620 | Luna® G3 BPAP 25A | January 29, 2021 |
| K200496 | Aer X | July 24, 2020 |
| K160127 | iCodeConnect | November 10, 2016 |
| K153387 | Luna CPAP and Auto CPAP System | September 8, 2016 |
| K141770 | LUNA CPAP AND AUTO-CPAP SYSTEM | April 22, 2015 |
| K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A | August 25, 2014 |
| K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | December 23, 2013 |
| K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP | December 6, 2013 |
| K131707 | 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS | August 22, 2013 |