FDA Device Intelligence
Home › Bionix, LLC › Swaddler for Phototherapy

Swaddler for Phototherapy

Bionix, LLC · Model 1105 · UDI-DI 00859911004283

PDH Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
4
Facilities

Description

Swaddler for PhotoTherapy: Newborn, regular

Recalls

DateFirmReason
2014-07-11Beevers Manufacturing & Supply, Inc.Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k)

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.