ClearanceBrief
Company ยท AU

Care Essentials Pty, Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2024. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
DWJSystem, Thermal Regulating5
FRGWrap, Sterilization1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 21, 2024K232502Cocoon Convective Warming System, Model CWS7000
Care Essentials Pty, Ltd., AU
DWJ
Mar 14, 2022K213907CareGUARD Sterilization Wrap
Care Essentials Pty, Ltd., AU
FRG
May 2, 2019K181671Cocoon Convective Warming System
Care Essentials Pty, Ltd., AU
DWJ
Jul 25, 2014K140635COCOON CONVECTIVE WARMING SYSTEM
Care Essentials Pty, Ltd., AU
DWJ

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 7, 2020Care Essentials Pty., Ltd.
Cocoon Convective Warming System, Product Code: CWS5000 (110V).
Terminated		 DWJK140635
Jan 7, 2020Care Essentials Pty., Ltd.
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
Terminated		 DWJK140635
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