Day

June 12, 1998
Resuscitaire Radiant Warmer, Infant Radiant Warmer: a) Resuscitaire Radiant Warmer, Model RW81; b) Resuscitaire Radiant Warmer, Model RW82; c) Resuscitaire Radiant Warmer, Model RW82VHA; d) Resuscitaire Radiant Warmer, Model WMRW82; e) Resuscitaire Radiant Warmer, Model WBR 81; f) Resuscitaire Radiant Warmer, Model WBR82. Recall #Z-292/297-9. REASON The device fails to control heater power due to...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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