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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 11 of 285

Device	Model / Reference	Registries	Class	Status
F111	SEF111XLM	FDA UDI	Class I	Active
Skirt	RTLSPRSK-6XF	FDA UDI	Class I	Active
Fvest	SSLFLOV-XLM	FDA UDI	Class I	Active
Pvest	R3PVEST-XXSF	FDA UDI	Class I	Active
F111	R3F111-MF	FDA UDI	Class I	Active
F111	REF1115XLM	FDA UDI	Class I	Active
Leg Wrap	UBLGW1	FDA UDI	Class I	Active
F01	SSSSTD-XLF	FDA UDI	Class I	Active
Gonad Shield	GONADSHIELDPSET-RLGSPSET-OV-STRAP	FDA UDI	Class I	Active
W114	R3W114-PLUS	FDA UDI	Class I	Active
Fvest	SPRFLOV-LM	FDA UDI	Class I	Active
Skirt	SPRWBSK-PF	FDA UDI	Class I	Active
Thyroid Shield	RBTSBMT-LG	FDA UDI	Class I	Active
A10	SEA10XXLM	FDA UDI	Class I	Active
Thyroid Shield	RLTSSHT-MD	FDA UDI	Class I	Active
Nike	EW-0006-SV	FDA UDI	Class I	Active
F01	S3F01-MM	FDA UDI	Class I	Active
Thyroidshield	RCCTSVB-LG	FDA UDI	Class I	Active
Fvest	SSSFLOV-3XF	FDA UDI	Class I	Active
Fvest	S8FVEST-3XF	FDA UDI	Class I	Active
Skirt	SSSWBSK-MF	FDA UDI	Class I	Active
Thyroid Shield	S3TSSHB-LG	FDA UDI	Class I	Active
F17	SBF17*M	FDA UDI	Class I	Active
F112	SEF112F	FDA UDI	Class I	Active
Zvest	REZVEST-3XF	FDA UDI	Class I	Active
Thyroid Shield	S8TSBHR-MD	FDA UDI	Class I	Active
Thyroid Shield	SBTSCHS-LG	FDA UDI	Class I	Active
Euro	UEEURO-SM	FDA UDI	Class I	Active
Skirt	SSSSPRSK-7XF	FDA UDI	Class I	Active
A10	RSLA10-SM	FDA UDI	Class I	Active
Nike	EW-0027-BIF	FDA UDI	Class I	Active
Thyroid Shield	S3TSCHN-LG	FDA UDI	Class I	Active
Thyroidshield	RTLTSBH-LG	FDA UDI	Class I	Active
Euro	SBEURO-MM	FDA UDI	Class I	Active
Skirt	SESKIRT-XSM	FDA UDI	Class I	Active
Fvest	SEFVEST-XXSF	FDA UDI	Class I	Active
F112	S3F112-2XF	FDA UDI	Class I	Active
Vest	S8VEST-XLM	FDA UDI	Class I	Active
Kilt	R3KILT-XLM	FDA UDI	Class I	Active
Thyroid Shield	UBTSSHB-MD	FDA UDI	Class I	Active
Dhalf	R8DHALFR-M	FDA UDI	Class I	Active
Zvest	UBZVEST-XSF	FDA UDI	Class I	Active
K303	S8K303-XLF	FDA UDI	Class I	Active
F17	ULF17B	FDA UDI	Class I	Active
F17	ECSBF17E	FDA UDI	Class I	Active
Thyroid Shield	UBTSOMR-LG	FDA UDI	Class I	Active
F01	RBF01-SM	FDA UDI	Class I	Active
F17	RLF174XLF	FDA UDI	Class I	Active
S302	S3S302-XLM	FDA UDI	Class I	Active
Thyroidshield	RCCTSVB-MD	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.