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F01

BURLINGTON MEDICAL, LLC · Model ULF01-LF · UDI-DI 00840331254792

EAJ
6
510(k) clearances
114
Adverse events (1 deaths)
25
Recalls
29
Facilities

Description

Custom F01: Frontal Apron with Back Strap and Tie Closure .25mm Regular Lead Size Female Large, ULF01-LF

Recalls

DateFirmReason
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s
2019-06-07Burlington Medical, LLCThe 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 s

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.