ClearanceBrief
Panels › Cardiovascular › Product code DWJ · Class 2

System, Thermal Regulating

Regulation 870.5900

5510(k)s in 12 months (161 all time)
3recalls in 12 months (70 all time)
58recalls that name a 510(k)
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Top companies in DWJ

Company510(k)sRecalls
Cincinnati Sub-Zero Products, Inc.914
Augustine Temperature Management413
Medivance, Inc.103
Augustine Medical, Inc.120
C.R. Bard, Inc.07
Gaymar Industries, Inc.60
Mtre Advanced Technology , Ltd.60
Smiths Medical Asd, Inc.42
Arizant Inc05
Care Essentials Pty, Ltd.32
Decided510(k)Device and applicantCode
Jun 2, 1986K854856THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT
Thermorite, Inc.
DWJ
Apr 29, 1982K820814THERMO-K
American Medical Systems, Inc.
DWJ
Dec 29, 1981K812955EAST WATER UNIT MARK 3
Cairco , Ltd.
DWJ
Aug 13, 1981K811742HEMOTHERM MODEL 400
Cincinnati Sub-Zero
DWJ
Jul 16, 1981K811743MAXITHERM
Cincinnati Sub-Zero
DWJ
Jan 2, 1981K801253CREST ELECTRONIC WARMING BLANKET
Penlon, Inc.
DWJ
Apr 24, 1980K800812MEDI-THERM
Gaymar Industries, Inc.
DWJ
Nov 15, 1977K772015PATIENT HEATER SYSTEM, MODEL PH112
Carolina Medical Electronics
DWJ
Sep 6, 1977K771537AQUAMATIC K-MODULE MODEL K-20
Gorman Rupp Industries
DWJ
Jun 8, 1977K770839AQUAMATIC K-77
Gorman Rupp Industries
DWJ
Dec 6, 1976K761087ELECTRONIC CONTROL UNIT
Gorman Rupp Industries
DWJ

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