Is this your brand? Sign in to claim ownership.

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 16 of 285

Device	Model / Reference	Registries	Class	Status
Pvest	R8PVEST-2XF	FDA UDI	Class I	Active
Fvest	SPRFLOV-XSF	FDA UDI	Class I	Active
Skirt	SPRWBSK-6XM	FDA UDI	Class I	Active
Sl	S5SL	FDA UDI	Class I	Active
601	RB601*F	FDA UDI	Class I	Unknown
Kilt	R8KILT-2XM	FDA UDI	Class I	Active
Euro	SLEUROXLF	FDA UDI	Class I	Active
601	RSS601-XXM	FDA UDI	Class I	Active
Fvest	SLFVEST-3XM	FDA UDI	Class I	Active
Euro	SBEUROXLM	FDA UDI	Class I	Active
Euro	RBEURO6XLF	FDA UDI	Class I	Active
601	R8601-2XF	FDA UDI	Class I	Active
F17	RLF173XLM	FDA UDI	Class I	Active
601	UL6015XLF	FDA UDI	Class I	Active
601	SB601E	FDA UDI	Class I	Active
W114	RLW114-3XM	FDA UDI	Class I	Active
F17	RLF17XLM	FDA UDI	Class I	Active
F111	RLF111XXLF	FDA UDI	Class I	Active
Kilt	RLKILTXSF	FDA UDI	Class I	Active
Euro	RLEURO*F	FDA UDI	Class I	Active
Qvest	S3QVEST-PLUS	FDA UDI	Class I	Active
W114	REW114-XSM	FDA UDI	Class I	Active
Euro	S8EURO*M	FDA UDI	Class I	Active
Thyroid Shield	R8TSSBN-MD	FDA UDI	Class I	Active
Vest	SSLRVST-LM	FDA UDI	Class I	Active
Euro	SEEURO-SF	FDA UDI	Class I	Active
Vest	STLRVST-5XM	FDA UDI	Class I	Active
Skirt	RCCSKIRT-LF	FDA UDI	Class I	Active
601	UL6013XLF	FDA UDI	Class I	Active
F111	RBF111-PLUS	FDA UDI	Class I	Active
Kilt	UBKILT-2XF	FDA UDI	Class I	Active
Thyroid Shield	SLTSOBN-MD	FDA UDI	Class I	Active
Pvest	R3PVEST*F	FDA UDI	Class I	Active
Thyroidshield	RTLTSVH-LG	FDA UDI	Class I	Active
Thyroid Shield	U3TSBHN-MD	FDA UDI	Class I	Active
Pvest	RCCPVST-SF	FDA UDI	Class I	Active
Euro	SBEURO-XXSF	FDA UDI	Class I	Active
Half Apron	R8HALF1B	FDA UDI	Class I	Active
Skirt	RLSKIRT-2XF	FDA UDI	Class I	Active
S302	RES302-XSM	FDA UDI	Class I	Active
601	RE601XSM	FDA UDI	Class I	Active
Pvest	RLPVEST-2XM	FDA UDI	Class I	Active
Porta Shield	PTSSHIELD3	FDA UDI	Class I	Active
Kilt	RLKILT-SM	FDA UDI	Class I	Active
Fvest	RSLFLOV-6XF	FDA UDI	Class I	Active
Pvest	RPRPVST-8XF	FDA UDI	Class I	Active
Thyroid Shield	S3TSCMT-LG	FDA UDI	Class I	Active
Thyroid Shield	U8TSOMT-MD	FDA UDI	Class I	Active
F17	S8F17-2XF	FDA UDI	Class I	Active
Half Apron	RBHALF1H	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.