3B Medical, Inc.
3B Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2013, most recent 2022, with 2 FDA device recalls on record.
Top product codes for 3B Medical, Inc.
FDA recalls by 3B Medical, Inc.
- Z-1815-2026 — React Health PHOENIX 5L Oxygen Concentrator
- Z-0828-2025 — Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by 3B Medical, Inc.
- K212263 — Luna G3 BPAP System
- K201620 — Luna® G3 BPAP 25A
- K200496 — Aer X
- K160127 — iCodeConnect
- K153387 — Luna CPAP and Auto CPAP System
- K141770 — LUNA CPAP AND AUTO-CPAP SYSTEM
- K133769 — 3B RESMART BPAP 25A, BMC RESMART BPAP 25A
- K131901 — IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
- K132967 — 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
- K131707 — 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.