Facility
IMPEDIMED, INC.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3005699942 |
|---|---|
| Establishment type | Develop Specifications But Do Not Manufacture At This Facility |
| Location | 5900 Pasteur Ct Ste 125 Carlsbad, CA, US 92008 |
| Registration status | Active · expires 2026 |
| Parent company | Impedimed, Inc. (owner-operator 9085941) |
Devices registered here (1)
- Plethysmograph, ImpedanceProduct code DSB · Class II · Cardiovascular · 21 CFR 870.2770
Recalls & enforcement
- Class IIOngoing2023-08-17Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and mor
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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