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Sources: EU EUDAMED, US FDA
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AVITA CORPORATION
FDA registration
AVITA CORPORATION·10 products·🇹🇼 Taiwan
Blood pressure monitor
FDA UDI
AVITA CORPORATION·04710953421161·The device is a arm type blood pressure monitor...
TekCare Touch Free Infrared Thermometer
FDA UDI
AVITA CORPORATION·04710953421291·The NT11 THERMO DISTANCE thermometer is designe...
TekCare Touch Free Infrared Thermometer
FDA UDI
AVITA CORPORATION·04710953421512·The NT17 THERMO DISTANCE thermometer is designe...
Blood pressure monitor
FDA UDI
AVITA CORPORATION·04710953420942·The device is a wrist type blood pressure monit...
Harbor Freight Tools
FDA UDI
AVITA CORPORATION·04710953421628·The product automatically measures human begins...
TekCare Infrared Thermometer
FDA UDI
AVITA CORPORATION·04710953421314·The device is an infrared thermometer intended ...
TekCare Green-Type Infrared Thermometer
FDA UDI
AVITA CORPORATION·04710953421468·The IR Thermometer is intended to be used as th...
TekCare Non-Contact Infrared Thermometer
FDA UDI
AVITA CORPORATION·04710953421598·The NT19 thermometer is designed for the interm...
TekCare Blood Pressure Monitor
FDA UDI
AVITA CORPORATION·04710953421338·BPM19 Series Blood Pressure Monitor applies the...
Tanita Corporation of Akita, Ltd
FDA registration
Tanita Corporation of Akita, Ltd·5 products·🇯🇵 Japan
AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709.
FDA Recall
Terminated
·Ohio Medical Corporation·Product code BTA·May 10, 2010
Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float; 6700-0018-800 - Bottle with V Wall Bracket, Cap & Float; 6700-0370-800 - Bottle with Floor Bracket, Cap & Float. The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
FDA Recall
Terminated
·Ohio Medical Corporation·Product code KDQ·September 21, 2009
Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: 0321-7986-801 - Bottle with Straight Wall Bracket, Cap & Float; 6700-0019-800 - Bottle with Floor Bracket, Cap & Float; 6700-0024-800 - Bottle with V Wall Bracket, Cap & Float. The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
FDA Recall
Terminated
·Ohio Medical Corporation·Product code KDQ·September 21, 2009
MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental, 769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales unit with case).
FDA Recall
Terminated
·Ohio Medical Corporation·Product code BTA·May 10, 2010