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BIONIX DEVELOPMENT CORPORATION
M&H Medical Holdings, Inc. · Model NP-1100 · UDI-DI 08599110040133
1
510(k) clearances
0
Adverse events
1
Recalls
4
Facilities
Description
Swaddler for PhotoTherapy, preemie
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-07-11 | Beevers 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) |
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Get your free API keyRead the docsData 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.