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Sign in to claim this brandBreg, Inc.
United States·US-MF-000018362
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2382, Faraday Avenue, Suite 300, Carlsbad, United States
- Website
- breg.com
- —
- —
- [email protected]
- Phone
- 8003210607
- PRRC Contact
- Monique Zamora
- EUDAMED SRN
- US-MF-000018362
- FDA FEI Number
- 3010694026
- DUNS Number
- 604483321
Catalogue (251)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Breg | 100579-000 | FDA UDI | Class II | Active |
| Breg | PC CUBE W/ KNEE WO | FDA UDI | Class II | Active |
| Breg | PAD RECT LG LS | FDA UDI | Class II | Active |
| Breg | NOVAPLUS PC KODIAK W/ IF KNEE | FDA UDI | Class II | Active |
| Breg | NOVAPLUS PC CUBE W/ WO KNEE L | FDA UDI | Class II | Active |
| Breg | PC GLACIER W/ M/U XL | FDA UDI | Class II | Active |
| Breg | PAD SHLDR WO | FDA UDI | Class II | Active |
| Breg | PAD INTELLI-FLO HIP | FDA UDI | Class II | Active |
| Breg | WRAP SHDLR S/M | FDA UDI | Class II | Unknown |
| Breg | PAD INTELLI FLO ANKLE COMPRESSION | FDA UDI | Class II | Active |
| Breg | EXTENSION PANEL, ASCEND BELT | FDA UDI | Class I | Active |
| Breg | PINNACLE CERV TX 174 W/O REPL PADS | FDA UDI | Class I | Active |
| Breg | NOVAPLUS PAD INTELLI FLO KNEE | FDA UDI | Class II | Active |
| Breg | NOVAPLUS PC CUBE W/ WO SHLDR XL | FDA UDI | Class II | Active |
| Breg | PC GLACIER W/ ANKLE WO | FDA UDI | Class II | Unknown |
| Breg | ASCEND SI BELT, LARGE | FDA UDI | Class I | Active |
| Breg | PINNACLE LSO 639/651 | FDA UDI | Class I | Active |
| Breg | PC KODIAK COMBO IFP ANKL CMP | FDA UDI | Class II | Active |
| Breg | NOVAPLUS PC CUBE W/ WO M/U LS XL | FDA UDI | Class II | Active |
| Breg | PAD M/U XL LS | FDA UDI | Class II | Active |
| Breg | POLAR CARE CUBE | FDA UDI | Class II | Active |
| Breg | NON-ELASTIC STRAP IF PAD, HIP | FDA UDI | Class II | Active |
| Breg | WRAP HIP L | FDA UDI | Class II | Unknown |
| Breg | PAD BACK WO | FDA UDI | Class II | Active |
| Breg | VPULSE W SEQ COMP PADS (2) | FDA UDI | Class II | Active |
| Breg | EPIC LSO 637/650 | FDA UDI | Class I | Active |
| Breg | POLAR CARE Y IN ADAPTOR | FDA UDI | Class II | Active |
| Breg | PAD ANKLE WO | FDA UDI | Class II | Active |
| Breg | EPIC LSO 631/648 | FDA UDI | Class I | Active |
| Breg | PAD INTELLI FLO KNEE COMPRESSION | FDA UDI | Class II | Active |
| Breg | PC KODIAK COMBO IFP SHLDR | FDA UDI | Class II | Active |
| Breg | PAD INTELLI-FLO BACK | FDA UDI | Class II | Active |
| Breg | POLAR DRESSING, 3x5 INTELLI-FLO | FDA UDI | Class I | Active |
| Breg | ASCEND SI BELT, MEDIUM | FDA UDI | Class I | Active |
| Breg | PINNACLE CTO4 200 | FDA UDI | Class I | Active |
| Breg | AUTO ADAPTER COLD THERAPY | FDA UDI | Class II | Unknown |
| Breg | PAD KNEE L WO | FDA UDI | Class II | Active |
| Breg | PC CUBE W/ KNEE/SHLDR | FDA UDI | Class II | Active |
| Breg | TOPSHELF WRAP SHDLR S/M | FDA UDI | Class I | Active |
| Breg | NOVAPLUS WO PAD KNEE XL | FDA UDI | Class II | Active |
| Breg | ASCEND LSO 631/648 | FDA UDI | Class I | Active |
| Breg | PINNACLE LSO 637/650 | FDA UDI | Class I | Active |
| Breg | HEEL CUP SILICONE L | FDA UDI | Class I | Active |
| Breg | PAD BACK W/LONG STRPS WO | FDA UDI | Class II | Active |
| Breg | EPIC LP TLSO 627/642 | FDA UDI | Class I | Active |
| Breg | POLAR CARE Y ADAPTOR (6') | FDA UDI | Class II | Unknown |
| Breg | PC GLACIER W/ SHLDR WO | FDA UDI | Class II | Active |
| Breg | PAD SHLDR W/LONG STRAPS WO | FDA UDI | Class II | Active |
| Breg | NOVAPLUS POLAR CARE KODIAK | FDA UDI | Class II | Active |
| Breg | PAD KIT, PINNACLE LUMBAR | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (13)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 13, 2023 | Z-0231-2024 | — | open, classified | Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels. |
| Mar 30, 2017 | Z-1902-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 30, 2017 | Z-1906-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 30, 2017 | Z-1904-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 30, 2017 | Z-1905-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 30, 2017 | Z-1903-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 30, 2017 | Z-1908-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 30, 2017 | Z-1907-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 30, 2017 | Z-1901-2017 | — | terminated | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. |
| Mar 14, 2014 | Z-1447-2014 | — | terminated | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label. |
| Mar 14, 2014 | Z-1446-2014 | — | terminated | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label. |
| Jan 14, 2013 | Z-0804-2013 | — | terminated | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. |
| Jan 14, 2013 | Z-0803-2013 | — | terminated | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. |