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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 (250)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Breg	EXTENSION PANEL, EPIC LP BELT	FDA UDI	Class I	Active
Breg	POLAR CARE GLACIER	FDA UDI	Class II	Active
Breg	HEEL CUP SILICONE M	FDA UDI	Class I	Active
Breg	ASCEND CERV 172, TALL, W/O REPL PADS	FDA UDI	Class I	Active
Breg	PAD INTELLI FLO 3X5	FDA UDI	Class II	Active
Breg	WRAPON PAD, HIP, WITH 29 IN STRAPS	FDA UDI	Class II	Active
Breg	PINNACLE CERVICAL COLLAR 172	FDA UDI	Class I	Active
Breg	PC CUBE W/ HIP WO	FDA UDI	Class II	Active
Breg	PINNACLE TLSO 464	FDA UDI	Class I	Active
Breg	NOVAPLUS PAD INTELLI FLO SHOULDER	FDA UDI	Class II	Active
Breg	ASCEND CERV 172, SHRT, W/O REPL PADS	FDA UDI	Class I	Active
Breg	PINNACLE CERVICAL COLLAR TX 174	FDA UDI	Class I	Active
Breg	PAD BACK	FDA UDI	Class II	Active
Breg	TOP SHELF KODIAK W/SHLDR	FDA UDI	Class II	Unknown
Breg	PAD INTELLI FLO KNEE	FDA UDI	Class II	Active
Breg	PC KODIAK COMBO IFP SHLDR XL	FDA UDI	Class II	Active
Breg	ASCEND CERV 172, REGULAR, W/O REPL PADS	FDA UDI	Class I	Active
Breg	ASCEND TLSO 456/457	FDA UDI	Class I	Active
Breg	PINNACLE CERV MP 180 W/O REPL PADS	FDA UDI	Class I	Active
Breg	PC GLACIER W/ M/U XL WO	FDA UDI	Class II	Active
Breg	NOVAPLUS PC KODIAK W/ IF SHLDR XL	FDA UDI	Class II	Active
Breg	PC CUBE W/ M/U XL WO	FDA UDI	Class II	Active
Breg	PINNACLE LSO 631/648	FDA UDI	Class I	Active
Breg	WRAP BACK M	FDA UDI	Class II	Unknown
Breg	TOPSHELF WRAP BACK L	FDA UDI	Class I	Active
Breg	ASCEND PD1 PED COLLAR W/O REPL PADS	FDA UDI	Class I	Active
Breg	DRESSING, KNEE L / XL	FDA UDI	Class I	Active
Breg	EXTENSION PANEL, PINNACLE BELT	FDA UDI	Class I	Active
Breg	PC KODIAK COMBO IFP KNEE CMP	FDA UDI	Class II	Active
Breg	DRESSING TMJ	FDA UDI	Class I	Active
Breg	PAD INTELLI-FLO WRIST	FDA UDI	Class II	Active
Breg	ASCEND PD5 PED COLLAR W/O REPL PADS	FDA UDI	Class I	Active
Breg	ASCEND CERVICAL COLLAR 172, REGULAR	FDA UDI	Class I	Active
Breg	TOP SHELF KODIAK MU LS	FDA UDI	Class II	Unknown
Breg	ASCEND LO 627/642	FDA UDI	Class I	Active
Breg	DRESSING SHLDR XL	FDA UDI	Class I	Active
Breg	PC GLACIER W/ KNEE/SHLDR	FDA UDI	Class II	Active
Breg	ASCEND PD2 PED COLLAR W/O REPL PADS	FDA UDI	Class I	Active
Breg	PAD KNEE/SHLDR	FDA UDI	Class II	Active
Breg	POLAR CARE KODIAK	FDA UDI	Class II	Active
Breg	PAD HND/WRST WO	FDA UDI	Class II	Active
Breg	ASCEND PD1 PEDIATRIC COLLAR	FDA UDI	Class I	Active
Breg	ASCEND CERVICAL COLLAR 172, TALL	FDA UDI	Class I	Active
Breg	ASCEND PD3 PEDIATRIC COLLAR	FDA UDI	Class I	Active
Breg	100581-000	FDA UDI	Class II	Unknown
Breg	NOVAPLUS WO PAD KNEE	FDA UDI	Class II	Active
Breg	PAD M/U XL WO	FDA UDI	Class II	Active
Breg	ASCEND PD3 PED COLLAR W/O REPL PADS	FDA UDI	Class I	Active
Breg	PAD M/U XL	FDA UDI	Class II	Active
Breg	100579-000	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.