FDA Device Intelligence
Home › BOUND TREE MEDICAL, LLC › Curaplex

Curaplex

BOUND TREE MEDICAL, LLC · Model 8600-01373 · UDI-DI 00812277033892

NZJLYU
2
510(k) clearances
4
Adverse events
2
Recalls
11
Facilities

Description

*Custom* LMPD PPE Kit Med

Recalls

DateFirmReason
2020-07-27Office Depot IncTest results revealed that the KN95 masks failed to filter greater than 95% of particulates.
2020-07-02Whirlpool CorporationThe rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.