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NEVESKIN
ELETTRONICA PAGANI SRL · Model NEVESKIN · UDI-DI 08056590170540
IME
Prescription
10
510(k) clearances
350
Adverse events (1 deaths)
12
Recalls
474
Facilities
Description
Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-25 | DJO, LLC | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2021-12-15 | MEDLINE INDUSTRIES, LP - Northfield | The product contains natural rubber latex but the label states that it does not. |
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.