Bausch Lomb

FDA Filings

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

FDA Registration(s)

FDA Filings

Device Company	Device	Date
PMA P910061S027 BAUSCH & LOMB	Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL)	2022-01-19
PMA P910071S018 BAUSCH & LOMB	ADATO Sil-Ol 5000 Silicone Oil	2021-12-02
BRINZOLAMIDE Oceanside Pharmaceuticals., Bausch & Lomb	Prescription Medication	2021-08-27
PMA P910061S026 BAUSCH & LOMB	enVista One-Piece Foldable Acrylic Intraocular Lens (IOL)	2021-01-04
PMA P910061S025 BAUSCH & LOMB	SofPort Posterior Chamber Intraocular Lenses	2019-02-28
PMA P010062S011 BAUSCH & LOMB	Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment	2018-07-19
PMN K170052 Bausch + Lomb	Stellaris Elite Vision Enhancement System	2017-04-19
PMN K162342 Bausch + Lomb	Stellaris Elite Vision Enhancement System	2017-03-24
PMA P010062S010 BAUSCH & LOMB	BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT	2016-07-25
PMA P910061S023 BAUSCH & LOMB	SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES	2016-06-27
PMA P910071S016 BAUSCH & LOMB	ADATO SIL-OL 5000 SILICONE OIL	2016-01-15
PMA P910061S022 BAUSCH & LOMB	SOFPORT/SOFLEX INTRAOCULAR LENSES	2015-11-05
PMA P910071S015 BAUSCH & LOMB	ADATO SIL-OL 5000 SILICONE OIL	2015-08-28
PMN K133486 BAUSCH & LOMB	STELLARIS PC VISION ENHANCEMENT SYSTEM	2014-03-12
PMN K133242 BAUSCH & LOMB	STELLARIS VISION ENHANCEMENT SYSTEM	2014-02-14
PMN K131958 BAUSCH & LOMB	BAUSCH & LOMB INJECTOR SYSTEM	2014-01-09
PMN K133146 BAUSCH & LOMB	BAUSCH + LUMB, VIS100 INJECTOR SYSTEM	2014-01-03
PMN K132481 BAUSCH & LOMB	EASY-LOAD LENS DELIVERY SYSTEM	2013-12-27
PMN K132593 BAUSCH & LOMB	CRYSTALSERT DELIVERY SYSTEM	2013-09-17
PMN K123736 BAUSCH & LOMB	CRYSTALSERT DELIVERY SYSTEM	2013-05-16
PMN K061157 BAUSCH & LOMB	SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS	2006-06-22
PMN K040913 BAUSCH & LOMB	NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)	2004-07-23
PMN K020927 BAUSCH & LOMB	BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS	2002-05-16
207795 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
203168 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
201006 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
200738 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
090143 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
090037 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
088089 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
087818 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
087506 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
078792 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
076622 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
076260 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
076128 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
076103 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
076025 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
075702 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
075585 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
075546 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
075358 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
075050 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074830 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074805 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074778 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074776 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074643 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074449 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074447 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074443 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074326 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074307 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
074188 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064135 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064134 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064120 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064068 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064067 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064065 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064064 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064063 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064055 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064053 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064052 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064048 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064047 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064046 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
064039 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
050804 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
040097 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040075 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040074 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040073 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040070 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040069 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040067 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040066 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040065 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040064 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040063 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
040059 ANDA BAUSCH AND LOMB		0000-00-00 00:00:00
022308 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
022211 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
021996 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
021737 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
021640 BLA BAUSCH AND LOMB		0000-00-00 00:00:00
021516 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
020803 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
020583 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
020569 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
020213 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
020065 NDA BAUSCH AND LOMB		0000-00-00 00:00:00
019907 NDA BAUSCH AND LOMB		0000-00-00 00:00:00

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Bausch + Lomb Ireland Limited400 Somerset Corporate Blvdbridgewater, NJ 08807 PMA NumberP050026 Supplement NumberS002 Date Received09/04/2020 Decision Date01/20/2023 Product Code MVF Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Bausch & Lomb, Inc.1400 North Goodman St.rochester, NY 14609-3547 PMA NumberP980006 Supplement NumberS035 Date Received08/12/2022 Decision Date09/29/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Bausch & Lomb, Inc.50 Technology Driveirvine, CA 92618 PMA NumberP060022 Supplement NumberS030 Date Received08/16/2022 Decision Date09/20/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Bausch & Lomb, Inc.50 Technologyirvine, CA 92618 PMA NumberP840039 Supplement NumberS064 Date Received07/11/2022 Decision Date08/09/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Bausch And Lomb, Inc.1400 North Goodman Streetrochester, NY 14609 PMA NumberP170035 Supplement NumberS017 Date Received05/04/2022 Decision Date06/01/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Bausch & Lomb, Inc.1400 North Goodman St.rochester, NY 14609-3547 PMA NumberP980006 Supplement NumberS034 Date Received02/22/2022 Decision Date03/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Bausch And Lomb, Inc.1400 North Goodman Streetrochester, NY 14609 PMA NumberP170035 Supplement NumberS016 Date Received02/22/2022 Decision Date03/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Bausch & Lomb, Inc.14853 Deveau Placeminnetonka, MN 55345 PMA NumberP850068 Supplement NumberS014 Date Received02/01/2022 Decision Date03/18/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Bausch & Lomb, Inc.1400 North Goodman St.rochester, NY 14609-3547 PMA NumberN16895 Supplement NumberS105 Date Received02/18/2022 Decision Date03/15/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Bausch & Lomb Americas Inc.
Bausch & Lomb Incoporated
Bausch & Lomb Incorperated
Bausch & Lomb Incorporate
Oceanside Pharmaceuticals.
Bausch & Lomb GmbH

Related Finance Registrations

NCAGE Code	2K395	BAUSCH AND LOMB
NCAGE Code	6F499	BAUSCH AND LOMB
CAGE Code	2K395	BAUSCH AND LOMB
CAGE Code	6F499	BAUSCH AND LOMB

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092226264	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	EMPTY PLASTIC TUBES	2 PKG
2020090552066	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	EMPTY PLASTIC TUBES	2 PKG
202008293270	Tamsui,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	P.O.NO.VCGMF 0000018183 ITEM N O.819007 MAGNA-PAGE MAGNFIERS HTS#9013.80.2000 . . . .	105 CTN
2020052057036	Le Havre,France -> New York, New York	PRODUITS PHARMACEUTIQUES HS CODE 300490	49 PKG
2020021438037	Le Havre,France -> New York, New York	PRODUIT PHARMACEUTIQUE HS CODE 30049000	68 PKG
2019112059749	Le Havre,France -> New York, New York	PRODUIT PHARMACEUTIQUE HS CODE 21069098	128 PKG
201905187931	Tamsui,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	P.O.NO.VCUCM00467777 ITEM NO. 819007 MAGNA-PAGE MAGNFIERS HT S#9013.80.2000 . . . .	105 CTN
2019040242087	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	ART FOR CONVEYING OR PACKING OF GOODS PLAST 4 PACKAGES 390 00 KG 5 328 M3 EMPTY PLATIC TUBES HS 3923.90 NOT STACKABLE	4 PKG