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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 3 of 6

Device	Model / Reference	Registries	Class	Status
Breg	PC GLACIER W/ M/U XL LS WO	FDA UDI	Class II	Active
Breg	WRAP HIP M	FDA UDI	Class II	Unknown
Breg	WRAPON PAD, HIP	FDA UDI	Class II	Active
Breg	VPULSE THERM PAD ANKL	FDA UDI	Class II	Unknown
Breg	PINNACLE CERVICAL COLLAR MP 180	FDA UDI	Class I	Active
Breg	DRESSING IF STER SHLDR XL	FDA UDI	Class I	Active
Breg	VPULSE THERM CMP PAD HIP NO LNR	FDA UDI	Class II	Unknown
Breg	IF HIP, STERILE POLAR DRESSING	FDA UDI	Class I	Active
Breg	DRESSING BACK, ANKLE, WRIST	FDA UDI	Class I	Active
Breg	HEEL LIFT L	FDA UDI	Class I	Active
Breg	ASCEND CERV 172, X-TALL, W/O REPL PADS	FDA UDI	Class I	Active
Breg	PC KODIAK COMBO IFP ANKL	FDA UDI	Class II	Active
Breg	TOP SHELF KODIAK W/MU	FDA UDI	Class II	Unknown
Breg	VPULSE W/O PADS	FDA UDI	Class II	Active
Breg	PC CUBE W/ M/U XL	FDA UDI	Class II	Active
Breg	PAD RECT S	FDA UDI	Class II	Active
Breg	PC GLACIER W/ KNEE WO	FDA UDI	Class II	Active
Breg	TOP SHELF KODIAK	FDA UDI	Class II	Unknown
Breg	WRAP ANKLE	FDA UDI	Class II	Unknown
Breg	PAD M/U LS	FDA UDI	Class II	Active
Breg	EPIC LP TLSO 456/457	FDA UDI	Class I	Active
Breg	PAD INTELLI FLO SHOULDER XL	FDA UDI	Class II	Active
Breg	VPULSE THERM COMP PAD BACK NO LNR	FDA UDI	Class II	Active
Breg	NOVAPLUS WO PAD SHLDR	FDA UDI	Class II	Active
Breg	WRAP SHDLR L/XL	FDA UDI	Class I	Active
Breg	PC CUBE W/ SHLDR XL WO	FDA UDI	Class II	Active
Breg	HEEL LIFT S	FDA UDI	Class I	Active
Breg	NOVAPLUS PC CUBE	FDA UDI	Class II	Active
Breg	PC CUBE W/ M/U XL LS WO	FDA UDI	Class II	Active
Breg	PAD M/U	FDA UDI	Class II	Active
Breg	POLAR CARE KODIAK COMBO INT-FLO HIP	FDA UDI	Class II	Active
Breg	100578-000	FDA UDI	Class II	Active
Breg	PC GLACIER W/ KNEE L WO	FDA UDI	Class II	Active
Breg	PC GLACIER W/ HIP WO	FDA UDI	Class II	Unknown
Breg	PC GLACIER W/ SHLDR XL WO	FDA UDI	Class II	Active
Breg	ASCEND PD4 PED COLLAR W/O REPL PADS	FDA UDI	Class I	Active
Breg	PC CUBE W/ KNEE XL WO	FDA UDI	Class II	Active
Breg	NOVAPLUS WO PAD SHLDR XL	FDA UDI	Class II	Active
Breg	NOVAPLUS WO PAD M/U XL	FDA UDI	Class II	Active
Breg	DRESSING M/U	FDA UDI	Class I	Active
Breg	PAD SHLDR LT XL WO	FDA UDI	Class II	Active
Breg	VPULSE SEQ COMP PAD (2)	FDA UDI	Class II	Active
Breg	NOVAPLUS POLAR PAD M/U	FDA UDI	Class II	Active
Breg	NOVAPLUS PC CUBE W/ MU XL	FDA UDI	Class II	Active
Breg	PC GLACIER W/ KNEE XL WO	FDA UDI	Class II	Active
Breg	PC KODIAK W/O TRANSFORMER	FDA UDI	Class II	Active
Breg	PC KODIAK COMBO IFP MU LS	FDA UDI	Class II	Active
Breg	TOPSHELF WRAP SHDLR L/XL	FDA UDI	Class I	Active
Breg	PAD SHLDR RT WO	FDA UDI	Class II	Active
Breg	ASCEND LSO 637/650	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.