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Breg, 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8003210607
PRRC Contact: Monique Zamora
EUDAMED SRN: US-MF-000018362
FDA FEI Number: 3010694026
DUNS Number: 604483321

Catalogue (251)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
Breg	NOVAPLUS PC KODIAK W/ IF SHLDR	FDA UDI	Class II	Active
Breg	UPGRADE KIT, PINNACLE TLSO 464	FDA UDI	Class I	Active
Breg	PC KODIAK COMBO IFP BACK	FDA UDI	Class II	Active
Breg	PAD KNEE XL WO	FDA UDI	Class II	Active
Breg	PINNACLE CTO 200	FDA UDI	Class I	Active
Breg	PAD INTELLI FLO SHOULDER	FDA UDI	Class II	Active
Breg	DRESSING RECT L	FDA UDI	Class I	Active
Breg	NOVAPLUS WO KNEE L	FDA UDI	Class II	Active
Breg	PINNACLE LO 627/642	FDA UDI	Class I	Active
Breg	PAD SHLDR RT XL WO	FDA UDI	Class II	Unknown
Breg	ASCEND CERVICAL COLLAR 172, SHORT	FDA UDI	Class I	Active
Breg	PAD INTELLI FLO ANKLE S	FDA UDI	Class II	Active
Breg	PAD EYE MASK	FDA UDI	Class II	Active
Breg	DRESSING KNEE/SHLDR	FDA UDI	Class I	Active
Breg	NOVAPLUS POLAR PAD KNEE/SHLDR	FDA UDI	Class II	Active
Breg	PAD M/U XL LS WO	FDA UDI	Class II	Active
Breg	PAD SHLDR LT WO	FDA UDI	Class II	Unknown
Breg	PAD SHLDR XL WO	FDA UDI	Class II	Active
Breg	PAD M/U XL WO	FDA UDI	Class II	Unknown
Breg	TOPSHELF WRAP BACK M	FDA UDI	Class I	Active
Breg	WRAP BACK L	FDA UDI	Class I	Active
Breg	HEEL CUP SILICONE S	FDA UDI	Class I	Active
Breg	ASCEND PD4 PEDIATRIC COLLAR	FDA UDI	Class I	Active
Breg	ASCEND SI BELT, SMALL	FDA UDI	Class I	Active
Breg	PC CUBE W/ ANKLE WO	FDA UDI	Class II	Active
Breg	100577-000	FDA UDI	Class II	Active
Breg	NOVAPLUS PAD INTELLI FLO MULTI USE	FDA UDI	Class II	Active
Breg	PAD INTELLI FLO MULTI USE LONG STEM	FDA UDI	Class II	Active
Breg	NOVAPLUS PC KODIAK W/ IF MU LS	FDA UDI	Class II	Active
Breg	HEEL LIFT M	FDA UDI	Class I	Active
Breg	NOVAPLUS PC CUBE W/ WO SHLDR	FDA UDI	Class II	Active
Breg	PAD ANKLE	FDA UDI	Class II	Active
Breg	NOVAPLUS PC CUBE W/ KNEE PAD	FDA UDI	Class II	Active
Breg	PC CUBE W/ SHLDR WO	FDA UDI	Class II	Active
Breg	PAD KNEE WO	FDA UDI	Class II	Active
Breg	DRESSING IF STER ANKLE	FDA UDI	Class I	Active
Breg	PAD KIT, ASCEND LUMBAR	FDA UDI	Class I	Active
Breg	PAD RECT L	FDA UDI	Class II	Active
Breg	PC CUBE W/ KNEE L WO	FDA UDI	Class II	Active
Breg	PAD INTELLI FLO MULTI USE	FDA UDI	Class II	Active
Breg	ASCEND PD2 PEDIATRIC COLLAR	FDA UDI	Class I	Active
Breg	PINNACLE CERV 172 W/O REPL PADS	FDA UDI	Class I	Active
Breg	WRAP KNEE/THIGH	FDA UDI	Class I	Active
Breg	100580-000	FDA UDI	Class II	Active
Breg	NOVAPLUS PC CUBE W/ WO KNEE XL	FDA UDI	Class II	Active
Breg	ASCEND CERVICAL COLLAR 172, X-TALL	FDA UDI	Class I	Active
Breg	DRESSING M/U XL	FDA UDI	Class I	Active
Breg	PC KODIAK COMBO IFP MU	FDA UDI	Class II	Active
Breg	ASCEND PD5 PEDIATRIC COLLAR	FDA UDI	Class I	Active
Breg	PAD INTELLI FLO ANKLE	FDA UDI	Class II	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.