Thermo Fisher Scientific

FDA Filings

This page includes the latest FDA filings for Thermo Fisher Scientific. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Thermo Fisher Scientific
Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/ml2019-11-06
Thermo Fisher Scientific
Thermo Scientific Sensititre ARIS HiQ System2019-11-06
Thermo Fisher Scientific
Thermo Scientific Sensititre ARIS HiQ System2019-11-06
Thermo Fisher Scientific
Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Imipenem-Relebactam In The Dilution Range Of 0.03/4-256/4 Ug/mL2019-10-16
Thermo Fisher Scientific
Sensititre 20-24 Hour Haemophilus Influenzae/Streptococcus Pneumoniae MIC Or Breakpoint Susceptibility System With Omadacycline In The Dilution Range Of 0.008 - 32 Ug/mL2019-02-15
Thermo Fisher Scientific
Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Eravacycline In The Dilution Range Of 0.008- 16 µg/mL2018-11-30
Thermo Fisher Scientific
Sensititre 18-24 Hour MIC Breakpoint Susceptibility System With Plazomicin In The Dilution Range Of 0.06-128 Ug/mL2018-08-08
Thermo Fisher Scientific
Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Meropenem/Vaborbactam In The Dilution Range Of 0.008/8 - 18/8 Ug/mL2017-12-01
THERMO FISHER SCIENTIFIC OY
INDIKO2011-06-28
Thermo Fisher Scientific
REMEL SPECTRA VRE2010-07-15
THERMO FISHER SCIENTIFIC (NALGE NUNC INTL)
NUNC IVF CENTERWELL AND ICSI DISHES2009-09-18
Thermo Fisher Scientific
QMS LIDOCAINE CALIBRATORS, MODEL 03746782009-07-17
THERMO FISHER SCIENTIFIC INC.
QMS LIDOCAINE2009-05-29
Thermo Fisher Scientific
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS2008-12-19
Thermo Fisher Scientific
MAS TOX CONTROL2008-04-30
Thermo Fisher Scientific
AMYLASE EPS REAGENT2007-05-22

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
BT Sure
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC2019-07-08
BT Sure
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC2019-07-08
BT Sure
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC2019-07-08
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-12-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-12-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Samco Clicktainer
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10
Sterile Specimen Container
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.2018-10-10

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