Adroit Medical Systems Inc

FDA Filings

This page includes the latest FDA filings for Adroit Medical Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1055823
FEI Number1000111140
NameADROIT MEDICAL SYSTEMS, INC.
Owner & OperatorADROIT MEDICAL SYSTEMS, INC.
Contact Address1146 CARDING MACHINE RD. --
Loudon TN 37774 US
Official Correspondent
  • EDWARD - TYMITZ
  • x-865-4588600-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1146 CARDING MACHINE RD.
LOUDON, TN 37774 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-2602023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-2302023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-2242023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-2202023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-2172023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-2122023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp WD-0602023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp WD-0302023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp WD-0202023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp WD-0172023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0502023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0442023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0432023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0412023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0302023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0262023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0242023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0212023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0202023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0192023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0182023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0172023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0142023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0122023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0102023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0082023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0042023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0032023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp 6202-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp 6201-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
HTP1500 Accessory 3116-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
HTP1500 3111-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Accessory; HTP1500 Bed Bracket 3109-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Mobile Ice 3105-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Accessory; HTP1500 3103-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
HTP1500 HTP15002023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp WD-0242023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp 1091-00012023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-9002023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0602023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0402023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp ST-0312023-12-18
ADROIT MEDICAL SYSTEMS, INC.
Surface Warming & Cooling System 3102-00012020-10-09
ADROIT MEDICAL SYSTEMS, INC.
Welmed Inc.2019-04-02
ADROIT MEDICAL SYSTEMS, INC.
Warming / Cooling Soft Drape2019-04-02
ADROIT MEDICAL SYSTEMS, INC.
RAC Medical Solutions2019-04-02
ADROIT MEDICAL SYSTEMS, INC.
Sheathing Technologies2017-07-11
ADROIT MEDICAL SYSTEMS, INC.
ThermalX2017-07-11
ADROIT MEDICAL SYSTEMS, INC.
Think Medical2017-07-10
ADROIT MEDICAL SYSTEMS, INC.
FXI2017-07-10
ADROIT MEDICAL SYSTEMS, INC.
American Health2017-07-10
ADROIT MEDICAL SYSTEMS, INC.
Soft-Temp2017-07-10
ADROIT MEDICAL SYSTEMS, INC.
MediChoice2017-07-10
ADROIT MEDICAL SYSTEMS, INC.
Soft-Air2013-08-28
ADROIT MEDICAL SYSTEMS, INC.
Mistral-Air Warming System2013-08-27
ADROIT MEDICAL SYSTEMS, INC.
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA01002008-06-06
ADROIT MEDICAL SYSTEMS, INC.
HTP-15002007-10-10
ADROIT MEDICAL SYSTEMS, INC.
AMS HEAT AND COLD THERAPY UNITS2001-02-09
ADROIT MEDICAL SYSTEMS, INC.
SAFEPASS STERILIZATION POUCH1998-01-29
ADROIT MEDICAL SYSTEMS, INC.
HTP-1500 LOCALIZED HEAT THERAPY PUMP1997-09-10
ADROIT MEDICAL SYSTEMS, INC.
STERILE SOFT-TEMP1997-01-10
ADROIT MEDICAL SYSTEMS, INC.
SOFT-TEMP1992-12-11
ADROIT MEDICAL SYSTEMS, INC.
SOFT-COVER1992-11-06

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202005027448Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyPOWER CORDS32 CTN
201912191382657037 -> Savannah, GeorgiaBLANKET312 PKG
2019111642178Yantian,China (Mainland) -> Los Angeles, CaliforniaBLACK THERMOFORMED TOP+POCKET,H.S.CODE:392690 1048 CTN
201910191085057037 -> Savannah, GeorgiaBLANKETS666 PKG
2019082439412Hong Kong,Hong Kong -> Long Beach, CaliforniaAC POWER CORD,HS CODE: 854442290034 CTN
2019081950476Yantian,China (Mainland) -> Los Angeles, CaliforniaPOND PUMP,HS CODE:8413709144 CTN
2019062143379Yantian,China (Mainland) -> Los Angeles, CaliforniaPOND PUMP,H.S.CODE:84137040 CTN
201906109404Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyAC POWER CORD,H.S.CODE:85444240 CTN

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