Stephen Gorski

FDA Filings

This page includes the latest FDA filings for Stephen Gorski. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012866928
FEI Number3012866928
NameStephen Gorski
Owner & OperatorBoyd Corporation GmbH
Contact AddressRudolf-Diesel Strasse 17
Syke DE-NI Niedersachsen 28857 DE
Official Correspondent
  • Marion Thielbar
  • 49-4242-6920-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3004149774
FEI Number3004149774
NameStephen Gorski
Owner & OperatorSENTEC AG
Contact AddressRINGSTRASSE 39 --
THERWIL CH-NOTA CH-4106 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device

Registration Number3006551178
FEI Number3006551178
NameStephen Gorski
Owner & OperatorHEALTHSTATS INTERNATIONAL PTE. LTD.
Contact AddressBreadTalk IHQ, #09-03 30 Tai Seng Street
SINGAPORE SG-NOTA 534013 SG
Official Correspondent
  • STEPHEN H GORSKI
  • 65-685-83248-x
US Agent
Importing Logistics Registration
ImporterWESTPRIME SYSTEMS INC
Address5751 CHINO AVENUE
Chino, CA 91710 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

Registration Number9617268
FEI Number1000352675
NameStephen Gorski
Owner & OperatorEnviteC-Wismar GmbH
Contact AddressAlter Holzhafen 19
Wismar DE-MV Mecklenburg-Vorpommern 23966 DE
Official Correspondent
  • Stephen H Gorski
  • 49-384-13601-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS 65 W 35739 PIPER RD
Eagle, WI 53119 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

Registration Number3004838836
FEI Number3004838836
NameStephen Gorski
Owner & OperatorEKF DIAGNOSTIC GMBH
Contact AddressEBENDORFER CHAUSEE 3 BARLEBEN/MADGEBURG
SAXONY-ANHALT DE-NOTA D-39179 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device

Registration Number3010370454
FEI Number3010370454
NameStephen Gorski
Owner & OperatorSensatronic GmbH
Contact AddressAlterholzhafen 19
Wismar DE-MV Mecklenburg-Vorpommern 23966 DE
Official Correspondent
  • Stephen H Gorski
  • 049-3841-7582040-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device

Registration Number3004148997
FEI Number3004148997
NameStephen Gorski
Owner & OperatorCITY TECHNOLOGY
Contact AddressWALTON ROAD --
PORTSMOUTH GB-NOTA PO6 1SZ GB
Official Correspondent
  • John E Darby
  • 44-239-2288100-8174
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65 W35739 Piper Road
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3007667885
FEI Number3007667885
NameStephen Gorski
Owner & OperatorKroemker Medizintechnik GmbH
Contact AddressNordring 27a
Bueckeburg DE-NI Niedersachsen 31675 DE
Official Correspondent
  • Stephen H Gorski
  • 49-5722-905441-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Stephen Gorski [EnviteC-Wismar GmbH]
MySign S Pulse Oximeter and Accessory SpO2 Sensors2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MySign PC Software2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MySign S Pulse Oximeter and Accessory SpO2 Sensors2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MySign PC Software2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MySign O Oxygen Measuring Device2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
EnviteC Reusable SpO2 Sensors2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
EnviteC Reusable SpO2 Sensors2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
EnviteC Reusable SpO2 Sensors2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
EnviteC Medical Oxygen Sensors2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
EnviteC OxiPen Pulse Oximeter and Accessories2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
EnviteC Reusable SoftTip SpO2 Sensors2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
EnviteC Reusable Multi-site Y-Sensor2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MOX92019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MOX62019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MOX42019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MOX32019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
MOX22019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
6050-0004-1102019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
AlcoQuant 6020 Plus2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
Flow Sensor SpiroQuant2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
Flow Sensor SpiroQuant H2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
Flow Sensor SpiroQuant A+2019-05-23
Stephen Gorski [EnviteC-Wismar GmbH]
Multicompatible EnviteC Reusable and Disposable SpO2 Sensors2019-05-22
Stephen Gorski [Kroemker Medizintechnik GmbH]
Infusion Stand Claw 60032019-02-12
Stephen Gorski [Kroemker Medizintechnik GmbH]
Infusion Stand 7502019-02-12
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BProSOft BT PC Software2018-07-25
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BPro BT Ambulatory Blood Pressure Monitoring System2018-07-25
Stephen Gorski [EKF DIAGNOSTIC GMBH]
DiaSpect TM Cuvettes2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
DiaSpect TM Analyzer2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult diagnostics Hemoglobin Cuvettes2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult diagnostics Hemoglobin Analyzer2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult Hb Control Solution Medium Level2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult Hb Control Solution Low Level2018-04-15
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Consult Hb Control Solution High Level2018-04-15
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BProSOft CASP PC Software2014-12-30
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
My-BP BP Management Application Software2014-12-30
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
MC3100+ Monitor2014-12-30
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
Healthstats A-Pulse CASPal Monitor2014-12-30
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo_Control microcuvettes2012-01-03
Stephen Gorski [EKF DIAGNOSTIC GMBH]
EKF Diagnostic Hemo_Control Hemoglobin Measurement System2012-01-03
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo_Control microcuvettes2012-01-03
Stephen Gorski [EKF DIAGNOSTIC GMBH]
EKF Diagnostic Hemo_Control Hemoglobin Measurement System2012-01-03
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22010-12-29
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V- CareNeT2010-12-29
Stephen Gorski [SENTEC AG]
SDMS SenTec Digital Monitoring System2010-12-29
Stephen Gorski [SENTEC AG]
RSS Series SpO2 Soft Sensors2010-12-29
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2010-12-29
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22010-12-29
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V- CareNeT2010-12-29
Stephen Gorski [SENTEC AG]
SDMS SenTec Digital Monitoring System2010-12-29
Stephen Gorski [SENTEC AG]
RSS Series SpO2 Soft Sensors2010-12-29
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2010-12-29
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22010-12-29
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V- CareNeT2010-12-29
Stephen Gorski [SENTEC AG]
SDMS SenTec Digital Monitoring System2010-12-29
Stephen Gorski [SENTEC AG]
RSS Series SpO2 Soft Sensors2010-12-29
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2010-12-29
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse CASPro Model T71002010-06-27
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse CASPpal Model T72002010-06-27
Stephen Gorski [Kroemker Medizintechnik GmbH]
Ultra Neb2008-12-31
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse PC Software2008-12-16
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse Arterial Pulse Waveform Analysis System2008-12-16
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2008-12-16
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2008-12-16
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2008-12-16
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo-Control2008-05-12
Stephen Gorski [EKF DIAGNOSTIC GMBH]
Hemo-Control2008-05-12
Stephen Gorski [CITY TECHNOLOGY]
MOX92007-12-10
Stephen Gorski [CITY TECHNOLOGY]
MOX72007-12-10
Stephen Gorski [CITY TECHNOLOGY]
MOX42007-12-10
Stephen Gorski [CITY TECHNOLOGY]
MOX32007-12-10
Stephen Gorski [CITY TECHNOLOGY]
MOX22007-12-10
Stephen Gorski [CITY TECHNOLOGY]
MOX12007-12-10
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
Healthstats BProSOft PC Software2007-05-15
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BPro Ambulatory Blood Pressure Monitoring System2007-05-15
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
Bpcalibrator Mc3000/Mc31002007-05-15

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