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Curaplex

BOUND TREE MEDICAL, LLC · Model 8600-01479 · UDI-DI 00810071632006

LNZ Prescription
1
510(k) clearances
39
Adverse events (3 deaths)
3
Recalls
2
Facilities

Description

*Custom* Curaplex THS Adult Intubation Kit

Recalls

DateFirmReason
2024-02-12Sarnova HC, LlcEndotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endo
2024-02-12Sarnova HC, LlcEndotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endo
2006-09-27Teleflex MedicalBiological indicator failed. Investigation eliminated all equipment and product related factors.

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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.