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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 35 of 285

Device	Model / Reference	Registries	Class	Status
Fvest	R8FVEST-PLUS	FDA UDI	Class I	Active
Thyroid Shield	SBTSVBT-SM	FDA UDI	Class I	Active
Skirt	RESKIRT-MF	FDA UDI	Class I	Active
F111	RLF111XXLM	FDA UDI	Class I	Active
Kilt	SEKILT-LF	FDA UDI	Class I	Active
Euro	ULEURO7XLF	FDA UDI	Class I	Active
Skirt	STLSPRSK-LF	FDA UDI	Class I	Active
601	RE6013XLF	FDA UDI	Class I	Active
Thyroid Shield	SETSVHR-LG	FDA UDI	Class I	Active
Euro	SLEURO6XLF	FDA UDI	Class I	Active
Vest	RSSRVST-LF	FDA UDI	Class I	Active
K303	U8K303-XSF	FDA UDI	Class I	Active
K303	RBK303-MF	FDA UDI	Class I	Active
Thyroid Shield	R8TSVBR-SM	FDA UDI	Class I	Active
Thyroid Shield	UBTSBBR-MD	FDA UDI	Class I	Active
Thyroid Shield	SETSBMN-LG	FDA UDI	Class I	Active
601	UB601XSM	FDA UDI	Class I	Active
W113	S3W113-LF	FDA UDI	Class I	Active
Thyroid Shield	RBTSSHS-LG	FDA UDI	Class I	Active
Thyroid Shield	R3TSOBT-MD	FDA UDI	Class I	Active
Thyroidshield	RSLTSOM-SM	FDA UDI	Class I	Active
Euro	U8EURO-LM	FDA UDI	Class I	Active
Qvest	UEQVEST-6XF	FDA UDI	Class I	Active
Kilt Blocker	S8KILTBLOCKER18X20	FDA UDI	Class I	Active
Thyroid Shield	R3TSBBN-LG	FDA UDI	Class I	Active
K303	UBK303-SM	FDA UDI	Class I	Active
Qvest	S3QVEST-8XF	FDA UDI	Class I	Active
Thyroidshield	RSLTSCM-MD	FDA UDI	Class I	Active
Thyroid Shield	S8TSCBN-LG	FDA UDI	Class I	Active
Vest	STLRVST-XSM	FDA UDI	Class I	Active
Fvest	UEFVEST-LF	FDA UDI	Class I	Active
Euro	RPREURO-XXF	FDA UDI	Class I	Active
Thyroid Shield	UBTSOBR-MD	FDA UDI	Class I	Active
Vest	RSSRVST-XLM	FDA UDI	Class I	Active
Skirt	R8SKIRT-MF	FDA UDI	Class I	Active
Skirt	RPRSPRSK-MM	FDA UDI	Class I	Active
F112	SSLF112-4XF	FDA UDI	Class I	Active
Kilt	U8KILT-PLUS	FDA UDI	Class I	Active
Euro	U8EURO-XXSF	FDA UDI	Class I	Active
Thyroid Shield	SLTSBBR-MD	FDA UDI	Class I	Active
P500	REP500-LG	FDA UDI	Class I	Active
Zvest	U8ZVEST-2XM	FDA UDI	Class I	Active
Thyroid Shield	RBTSCBS-MD	FDA UDI	Class I	Active
A10	SLA10-2XF	FDA UDI	Class I	Active
Thyroidshield	RSSTSBM-SM	FDA UDI	Class I	Active
Thyroid Shield	U8TSOHT-LG	FDA UDI	Class I	Active
Thyroid Shield	S8TSVHS-MD	FDA UDI	Class I	Active
Thyroid Shield	R8TSVMT-SM	FDA UDI	Class I	Active
Pvest	RPRPVST-MF	FDA UDI	Class I	Active
Euro	REEURO*M	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.