Bausch

FDA Filings

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

Latest Premarket Notifications

ManufacturerDevice NameDate
Bausch Health Americas Incorporated
BIAFINE Topical Cream2019-10-18
Bausch & Lomb, Inc
Bausch + Lomb PreVue Inserter For EnVista Preloaded2019-10-04
Bausch & Lomb, Incorporated
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens2019-02-12
Bausch & Lomb Incorporated
Ultra (samfilcon A) Multifocal For Astigmatism Contact Lens2018-11-30
Bausch & Lomb Incorporated
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner2018-08-10
Bausch And Lomb Incorporated
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution2018-03-27
Bausch & Lomb, Inc
Crystalsert Lens Delivery System2017-12-11
Bausch & Lomb Incorporated
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions2017-11-27
Bausch & Lomb Incorporated
Bausch + Lomb Boston Scleral Lens Case2017-11-17
BAUSCH + LOMB Incorporated
Boston Xo (hexafocon A), Boston Xo2 (hexafocon B)2017-07-17
Bausch + Lomb
Stellaris Elite Vision Enhancement System2017-04-19
Bausch & Lomb Incorporated
Bausch + Lomb Sensitive Eyes Plus Saline Solution2017-04-11
Bausch + Lomb
Stellaris Elite Vision Enhancement System2017-03-24
Bausch & Lomb Incorporated
NNR06 Multi-Purpose Solution2016-11-25
Bausch And Lomb, Inc.
Easy-load Lens Delivery System2016-07-06
BAUSCH & LOMB INCORPORATED
Biotrue ONEday With NaturMoist, Biotrue ONEday For Presbyopia With NaturMoist, Biotrue ONEday For Astigmatism With NaturMoist2016-02-11
Bausch & Lomb, Inc.
Bausch + Lomb Injector System2015-05-22
Bausch & Lomb Incorporated
Bausch + Lomb Biotrue ONEday For Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens2015-02-13
BAUSCH & LOMB
STELLARIS PC VISION ENHANCEMENT SYSTEM2014-03-12
BAUSCH & LOMB
Stellaris Vision Enhancement System2014-02-14
BAUSCH & LOMB
BAUSCH & LOMB INJECTOR SYSTEM2014-01-09
BAUSCH & LOMB
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM2014-01-03
BAUSCH & LOMB
Easy-load Lens Delivery System2013-12-27
BAUSCH & LOMB INCORPORATED
Bausch + Lomb Bioture Oneday For Presbyopia (nesofilcon A) Contact Lens2013-12-20
BAUSCH & LOMB
Crystalsert Delivery System2013-09-17
BAUSCH & LOMB, INC.
Bausch + Lomb Procomfort (samfilcon A) Contact Lens, Bausch + Lomb Procomfort (samfilcon A) Contact Lens For Presbyopia,2013-09-11
BAUSCH & LOMB INCORPORATED
Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution2013-09-09
BAUSCH & LOMB
Crystalsert Delivery System2013-05-16
BAUSCH & LOMB, INC.
Bausch & Lomb Purevision (balafilcon A) Visibility Tinted Contact Lens, Bausch & Lomb Purevision Toric (balafilcon A) Vi2012-12-20
BAUSCH & LOMB, INC.
Bausch & Lomb Iol Injector2012-09-28

Latest Premarket Applications

PMAManufacturerDevice NameDate
Bausch & Lomb, Inc.
enVista Hydrophobic Acrylic Intraocular Lens (IOL)2020-01-21
Bausch & Lomb, Inc.
Akreos One-Piece Acrylic Intraocular Lens (IOL)2020-01-21
Bausch & Lomb, Inc.
enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)2020-01-16
Bausch And Lomb, Inc.
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses2019-12-18
Bausch & Lomb, Inc.
PureVision (balafilcon A) Contact Lens2019-10-10
Bausch & Lomb, Inc.
Silsoft (elastofilcon A) Contact Lens2019-10-10
Bausch And Lomb, Inc.
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses2019-09-12
Bausch & Lomb, Inc.
enVista Hydrophobic Acrylic Intraocular Lens (IOL)2019-08-06
Bausch And Lomb, Inc.
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses2019-08-01
Bausch & Lomb, Inc.
enVista One Piece Hydrophobic Acrylic Intraocular Lens2019-07-02
Bausch And Lomb, Inc.
BAUSCH + LOMB Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens2019-05-08
BAUSCH & LOMB
SofPort Posterior Chamber Intraocular Lenses2019-02-28
Bausch & Lomb, Inc.
PMMA Anterior Chamber Intraocular Lenses2019-02-28
Bausch & Lomb, Inc.
PMMA Posterior Chamber Intraocular Lenses2019-02-28
Bausch & Lomb, Inc.
enVista Hydrophobic Acrylic Intraocular Lens2018-11-06
Bausch & Lomb, Inc.
enVista One Piece Hydrophobic Acrylic Intraocular LEns (IOL)2018-10-31
Bausch & Lomb, Inc.
Akreos Intraocular Lens2018-08-07
Bausch & Lomb, Inc.
enVista Hydrophobic Arcylic Intraocular Lens2018-08-06
Bausch & Lomb, Inc.
SofLEns 38 (polymacon) Visibility Tinted Contact Lens2018-08-03
BAUSCH & LOMB
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment2018-07-19
Bausch & Lomb, Inc.
Enhanced enVista Hydrophobic Acrylic Intraocular Lens (IOL)2018-07-10
Bausch & Lomb, Inc.
SofLens 38 (polymacon) Visibility Tinted Contact Lens2018-06-11
Bausch & Lomb, Inc.
enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)2018-06-08
Bausch And Lomb, Inc.
Bausch + Lomb Ultra (samfilcon A) Contact Lenses2018-04-30
Bausch & Lomb, Inc.
Bausch & Lomb PureVision (balafilcon A) Contact Lenses2018-04-10
Bausch & Lomb, Inc.
PureVision (balafilcon A) Visibility Tinted Contact Lens2018-03-29
Bausch & Lomb, Inc.
enVista One Piece Hydrophobic Acrylic Intraocular Lens Vial Manufacturing2018-01-11
Bausch & Lomb, Inc.
EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder2017-12-04
Bausch & Lomb, Inc.
enVista Hydrophobic Acrylic Intraocular Lens2017-11-01
Bausch & Lomb, Inc.
SofLens (polymacon) Visibility Tinted Contact Lens2017-08-11

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Bausch + Lomb
Bausch & Lomb Incorporated2020-02-17
Bausch + Lomb
Bausch & Lomb Incorporated2020-02-17
Bausch + Lomb
Bausch & Lomb Incorporated2020-02-17
Bausch + Lomb
Bausch & Lomb Incorporated2020-02-17
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-27
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-25
PPT CRYSTALENS 12/BX
Bausch & Lomb GmbH2019-11-08
PPT MICS 6/BX
Bausch & Lomb GmbH2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-11-08
Bausch + Lomb
Bausch & Lomb Incorporated2019-10-07
Bausch + Lomb
Bausch & Lomb Incorporated2019-10-07

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