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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 3 of 285

Device	Model / Reference	Registries	Class	Status
Thyroid Shield	UBTSSBB-SM	FDA UDI	Class I	Active
Thyroid Shield BAT	R8BATM	FDA UDI	Class I	Active
601	UE601-PLUS	FDA UDI	Class I	Active
Vest	SEVEST-MM	FDA UDI	Class I	Active
K303	U8K303-MM	FDA UDI	Class I	Active
F111	SLF111XSM	FDA UDI	Class I	Active
Pvest	RBPVEST-MF	FDA UDI	Class I	Active
Kilt	SPRKILT-XXF	FDA UDI	Class I	Active
Fvest	UBFVEST-LF	FDA UDI	Class I	Active
Fvest	S8FVEST-XLM	FDA UDI	Class I	Active
Pvest	STLPVST-XXF	FDA UDI	Class I	Active
Qvest	SEQVEST-MF	FDA UDI	Class I	Active
Skirt	RCCWBSK-4XM	FDA UDI	Class I	Active
Euro	SSSEURO-4XM	FDA UDI	Class I	Active
F112	RPRF112-XLM	FDA UDI	Class I	Active
Euro	RSLEURO-SM	FDA UDI	Class I	Active
F17	SCCF17-MF	FDA UDI	Class I	Active
Skirt	STLWBSK-4XF	FDA UDI	Class I	Active
Arm Guard	TAGCOMBO-M	FDA UDI	Class I	Active
A10	SLA10XLM	FDA UDI	Class I	Active
Leg Wrap	R8LGW1	FDA UDI	Class I	Active
F17	SSLF17-MM	FDA UDI	Class I	Active
Euro	UEEURO-LM	FDA UDI	Class I	Active
Skirt	SCCSKIRT-8XM	FDA UDI	Class I	Active
Pvest	R3PVEST-XLF	FDA UDI	Class I	Active
601	SB601-3XM	FDA UDI	Class I	Active
Euro	S8EURO-XLF	FDA UDI	Class I	Active
Thyroidshield	RPRTSSB-MD	FDA UDI	Class I	Active
Blocker	R8BLOCKER1	FDA UDI	Class I	Active
S302	SES302-SM	FDA UDI	Class I	Active
Blocker	R8BLOCKER2	FDA UDI	Class I	Active
K303	RLK303-2XM	FDA UDI	Class I	Active
Skirt	SSLSKIRT-PF	FDA UDI	Class I	Active
Skirt	SPRSPRSK-4XF	FDA UDI	Class I	Active
Zvest	R8ZVEST-SF	FDA UDI	Class I	Active
F123	STLF111-LF	FDA UDI	Class I	Active
Thyroid Shield	R8TSBMR-SM	FDA UDI	Class I	Active
Thyroid Shield	RETSCBS-SM	FDA UDI	Class I	Active
Demi	RPRHD-SET	FDA UDI	Class I	Active
601	RL601XLF	FDA UDI	Class I	Active
F17	ECSBF17A	FDA UDI	Class I	Active
601	UL601XXLF	FDA UDI	Class I	Active
F01	REF01-4XF	FDA UDI	Class I	Active
K303	UBK303-XSF	FDA UDI	Class I	Active
F111	RTLF111-XLF	FDA UDI	Class I	Active
Skirt	STLSKIRT-7XF	FDA UDI	Class I	Active
Fvest	RSSFLOV-6XM	FDA UDI	Class I	Active
Kilt	R8KILT-SF	FDA UDI	Class I	Active
K303	S5K303	FDA UDI	Class I	Active
Thyroid Shield	R8TSSBB-LG	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.