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BURLINGTON MEDICAL, LLC

Last updated September 17, 2026

Information

Country: US
Address: 3 ELMHURST ST., Newport News, VA, 23603
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000120804
DUNS Number: —

Catalogue (14228)

Page 18 of 285

Device	Model / Reference	Registries	Class	Status
601	RTL601-LM	FDA UDI	Class I	Active
A10	UEA10-SF	FDA UDI	Class I	Active
Euro	ECRBEUROD	FDA UDI	Class I	Active
Thyroid Shield	S3TSVHS-MD	FDA UDI	Class I	Active
Thyroid Shield	RBTSBHN-LG	FDA UDI	Class I	Active
Pvest	SPRPVST-XLF	FDA UDI	Class I	Active
Vest	RSSRVST-7XM	FDA UDI	Class I	Active
Skirt	RPRSKIRT-7XM	FDA UDI	Class I	Active
Kilt	RSSKILT-XXM	FDA UDI	Class I	Active
F111	SSLF111-XSF	FDA UDI	Class I	Active
F17	SBF174XLM	FDA UDI	Class I	Active
Skirt	S8SKIRT-XSM	FDA UDI	Class I	Active
Vest	R5VEST	FDA UDI	Class I	Active
F111	REF1113XLF	FDA UDI	Class I	Active
F112	U8F112-SM	FDA UDI	Class I	Active
Thyroid Shield	RETSSHT-SM	FDA UDI	Class I	Active
F111	RBF111-XXSF	FDA UDI	Class I	Active
Thyroid Shield	SLTSOBN-SM	FDA UDI	Class I	Active
Blocker	U3BLOCKER3	FDA UDI	Class I	Active
F17	U8F17-XSM	FDA UDI	Class I	Active
Kilt	S3KILT-PLUS	FDA UDI	Class I	Active
Sleeve	UBSL3-SM	FDA UDI	Class I	Active
Skirt	S3SKIRT-XLF	FDA UDI	Class I	Active
Vest	U8VEST-MF	FDA UDI	Class I	Active
A10	SEA10F	FDA UDI	Class I	Active
F17	STLF17-SF	FDA UDI	Class I	Active
A10	RSSA10-4XM	FDA UDI	Class I	Active
Skirt	RSLSKIRT-SF	FDA UDI	Class I	Active
F111	SSSF111-6XF	FDA UDI	Class I	Active
Vest	RSSRVST-3XF	FDA UDI	Class I	Active
Thyroid Shield	U8TSOMB-LG	FDA UDI	Class I	Active
601	RB601*M	FDA UDI	Class I	Unknown
W114	U3W114-XLF	FDA UDI	Class I	Active
F112	STLF112-8XM	FDA UDI	Class I	Active
Vest	SBVEST-LM	FDA UDI	Class I	Active
F112	SCCF112-3XF	FDA UDI	Class I	Active
Ray-Ban	EW-0036-PRG	FDA UDI	Class I	Active
Under Armour	EW-0011-BIF	FDA UDI	Class I	Active
Euro	R3EURO-SF	FDA UDI	Class I	Active
A10	RBA10-LF	FDA UDI	Class I	Active
Kilt Blocker	ULKILTBLOCKERSET	FDA UDI	Class I	Active
Pvest	RSLPVST-MM	FDA UDI	Class I	Active
Skirt	SESKIRT-SF	FDA UDI	Class I	Active
W114	RLW114-MM	FDA UDI	Class I	Active
A10	RLA10XLM	FDA UDI	Class I	Active
Pvest	RSLPVST-XLM	FDA UDI	Class I	Active
A10	SSSA10-SM	FDA UDI	Class I	Active
F112	SCCF112-LF	FDA UDI	Class I	Active
Euro	REEURO*F	FDA UDI	Class I	Active
Caliper	P Caliper	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (37)

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
Feb 11, 2026	Z-1764-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1758-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1760-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1759-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1756-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1755-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1754-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1765-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1757-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1761-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1762-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1753-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Feb 11, 2026	Z-1763-2026	—	open, classified	Potential for attenuation degradation over time, decreasing the lifespan.
Jun 7, 2019	Z-2129-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2127-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2117-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2125-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2108-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2130-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2124-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2110-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2121-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2107-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2111-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2122-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2119-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2116-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2115-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2113-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2118-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2120-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2126-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2109-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2114-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2128-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2112-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Jun 7, 2019	Z-2123-2019	—	terminated	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.