BAUSCH

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1032500	1032500	Bausch & Lomb Incorporated	1	N	2026-01-01	8507 PELHAM RD. GREENVILLE SC US 29615
1119279	1119279	Bausch & Lomb Incorporated	1	N	2026-01-01	21 PARK PLACE BLVD. NORTH CLEARWATER FL US 33759
1123818	1000305478	Bausch & Lomb Incorporated	1	Y	2026-01-01	1501 Graves Mill Rd Lynchburg VA US 24502
1225992	3002516360	BAUSCH ARTICULATING PAPERS, INC.	1	Y	2026-01-01	12 Murphy Drive, Unit D-2 NASHUA NH US 03062
1281950	1281950	Bausch & Lomb Incorporated	1	N	2026-01-01	100 RESEARCH DRIVE WILMINGTON MA US 01887
1313525	1317628	Bausch & Lomb Incorporated	1	Y	2026-01-01	1400 North Goodman Street Rochester NY US 14609
1315522	1315522	Bausch & Lomb Incorporated	1	N	2026-01-01	6 Lancaster Pkwy Lancaster NY US 14086
1920664	1920664	Bausch & Lomb Incorporated	1	Y	2026-01-01	3365 TREE CT. INDUSTRIAL BLVD. Saint Louis MO US 63122
1932180	1000119305	Bausch & Lomb Incorporated	1	Y	2026-01-01	499 SOVEREIGN CT. Manchester MO US 63011
9610731	3002806454	Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland	1	N	2026-01-01	UNIT 424/425, CONTACT LENS DIVISION INDUSTRIAL ESTATE, CORK RD WATERFORD Munster IE --
3003365815	3003365815	Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre	1	N	2026-01-01	KOOLHOVENLAAN 110 SCHIPOL RIJK Noord-Holland NL 1119 NH
3009443653	3009443653	Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)	1	Y	2026-01-01	400 Somerset Corp Blvd. Suite 1 Bridgewater NJ US 08807

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
26861	1924904144	P990027	TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)	LZS	2000-02-23
26864	1367607607	P980006	PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR	LPM	1999-02-05
26884	1367607607	P980006	PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR	LPM	1999-02-05
26864	1495093030	P960022	SOFLENS66(TM)	LPM	1996-12-16
26865	1495093030	P960022	SOFLENS66(TM)	LPM	1996-12-16
26876	1495093030	P960022	SOFLENS66(TM)	LPM	1996-12-16
26884	1495093030	P960022	SOFLENS66(TM)	LPM	1996-12-16
26859	1262809509	P920055
26864	1262809509	P920055
26864	2011691514	P910071	ADATOMED SILICONE OIL OP5000	LWL	1994-11-04
26876	2011691514	P910071	ADATOMED SILICONE OIL OP5000	LWL	1994-11-04
26864	1364362718	P910061	MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS	HQL	1994-09-02
26882	1364362718	P910061	MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS	HQL	1994-09-02
26864	1247276092	P910056	SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	1992-01-17
26881	1247276092	P910056	SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	1992-01-17
26882	1247276092	P910056	SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	1992-01-17
26882	1200713581	P890040	SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS	LPM	1989-09-28
26864	1040976670	P880090	MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS	HQL	1989-12-28
26882	1040976670	P880090	MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS	HQL	1989-12-28
26864	1104600241	P860047	HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML	LZP	1988-07-12
26859	1587163661	P860023
26864	1587163661	P860023
26864	1995452867	P860022	BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS	MWL	1987-11-30
26881	1995452867	P860022	BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS	MWL	1987-11-30
26864	2048469653	P850068	SILSOFT (ELASTOFILCON A) CONTACT LENSES	LPM	1985-12-31
26884	2048469653	P850068	SILSOFT (ELASTOFILCON A) CONTACT LENSES	LPM	1985-12-31
26864	1118358508	P840039	ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES	HQL	1986-03-28
26882	1118358508	P840039	ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES	HQL	1986-03-28
26859	1164982675	P830013
26864	1164982675	P830013
26859	1989362581	P820070
26864	1989362581	P820070
26859	1952502352	P820069
26864	1952502352	P820069
26864	1413988519	P820065
26881	1413988519	P820065
26859	1636301191	P820031
26864	1636301191	P820031
26882	1900565206	P820005
26859	1534190269	P810039
26864	1534190269	P810039
26864	1116723696	P810025	AMVISC(R)	LZP	1983-10-18
26859	2072386062	P800024
26864	2072386062	P800024
26864	1383805644	P240005	enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)	MFK	2024-10-10
26882	1383805644	P240005	enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)	MFK	2024-10-10
26864	1788266817	P220009	StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)	LZP	2023-02-22
26882	1788266817	P220009	StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)	LZP	2023-02-22
26864	1758114549	P210005	IC-8 Apthera Intraocular Lens (IOL)	POE	2022-07-22
26882	1758114549	P210005	IC-8 Apthera Intraocular Lens (IOL)	POE	2022-07-22
26864	1562050266	P200025	ClearVisc Ophthalmic Viscosurgical Device (OVD)	LZP	2021-03-23
26864	2054594994	P170035	Bausch + Lomb Ultra (samfilcon A) Contact Lenses	LPM	2018-04-30
26884	2054594994	P170035	Bausch + Lomb Ultra (samfilcon A) Contact Lenses	LPM	2018-04-30
26864	1684098931	P080004	HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS	HQL	2008-09-26
26864	1777102826	P060022	AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT	HQL	2008-09-05
26881	1777102826	P060022	AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT	HQL	2008-09-05
26882	1777102826	P060022	AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT	HQL	2008-09-05
26864	1396721261	P030002	CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)	NAA	2003-11-14
26882	1396721261	P030002	CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)	NAA	2003-11-14
26864	1307273208	P010062	EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR	NUU	2004-06-07
26881	1307273208	P010062	EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR	NUU	2004-06-07
26864	1866066809	P010059	MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C	MRJ	2003-10-23
26864	1532772991	N17676
26881	1532772991	N17676
26882	1532772991	N17676
26884	1532772991	N17676
26864	1030173908	N16895	SOFLENS CONTACT LENSES (POLYMACON)	LPM	1971-03-18
26865	1030173908	N16895	SOFLENS CONTACT LENSES (POLYMACON)	LPM	1971-03-18
26884	1030173908	N16895	SOFLENS CONTACT LENSES (POLYMACON)	LPM	1971-03-18
26864	1196636909	K993039	VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)	MRH	2000-01-07
26861	1348105776	K984443	ORBSCAN	MXK	1999-03-05
75179	1087274039	K983278	OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)	LPL	1998-11-25
75179	1722640252	K983053	ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)	LPL	1998-10-21
75179	1695999545	K981252	OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)	LPL	1998-06-23
26861	2025766045	K980797	PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR	MPA	1998-05-19
26864	2025766045	K980797	PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR	MPA	1998-05-19
26864	1680496884	K980741	BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)	HQD	1998-05-11
26881	1680496884	K980741	BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)	HQD	1998-05-11
26859	1977965821	K980591	RENU MULTIPLUS LUBRICATING & REWETTING DROPS	LPN	1998-06-24
26864	1977965821	K980591	RENU MULTIPLUS LUBRICATING & REWETTING DROPS	LPN	1998-06-24
75179	1324230891	K980554	ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)	LPL	1998-04-07
26859	1215154239	K980133	BAUSCH & LOMB WETTING AND SOAKING SOLUTION	LPN	1998-03-11
26864	1215154239	K980133	BAUSCH & LOMB WETTING AND SOAKING SOLUTION	LPN	1998-03-11
26864	1993496992	K974780	SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS	LPL	1998-03-11
26859	1250305485	K974723	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	LPN	1998-03-10
26864	1250305485	K974723	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	LPN	1998-03-10
26859	1807463840	K974466	BOSTON ADVANCE CLEANER	MRC	1998-02-19
26864	1807463840	K974466	BOSTON ADVANCE CLEANER	MRC	1998-02-19
75179	1407210777	K973967	AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)	LPL	1997-12-08
26859	1823065587	K973217	BOSTON LIQUID ENZYMATIC CLEANER	LPN	1997-11-24
26864	1823065587	K973217	BOSTON LIQUID ENZYMATIC CLEANER	LPN	1997-11-24
26864	1642901305	K972901	AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD	GEI	1997-09-19
26864	1301031980	K972454	OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS	LPL	1997-08-08
26861	1003690145	K971439	STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES	HQC	1997-06-17
26864	1003690145	K971439	STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES	HQC	1997-06-17
26864	1498394002	K970727	MPORT FOLDABLE LENS PLACEMENT SYSTEM	MSS	1997-12-17
26882	1498394002	K970727	MPORT FOLDABLE LENS PLACEMENT SYSTEM	MSS	1997-12-17
26864	1459024638	K970698	BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS	HQD	1997-05-06
26881	1459024638	K970698	BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS	HQD	1997-05-06
136213	1643611000	K964240	BIAFINE WOUND DRESSING EMULSION	MGQ	1997-01-22
26861	1565122674	K963434	VISCOUS FLUID SYSTEM	MRH	1996-11-25
26864	1565122674	K963434	VISCOUS FLUID SYSTEM	MRH	1996-11-25
26861	1695694137	K962131	STORZ D4600 AIR EXCHANGE LINE PACK	HQC	1996-08-23
26864	1695694137	K962131	STORZ D4600 AIR EXCHANGE LINE PACK	HQC	1996-08-23
26861	1149803709	K961310	STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)	HQC	1996-06-27
26864	1149803709	K961310	STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)	HQC	1996-06-27
26882	1036440758	K960926	POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS	LPL	1996-04-10
26861	1664523070	K960024	STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH	HQC	1996-09-20
26864	1664523070	K960024	STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH	HQC	1996-09-20
26868	1664523070	K960024	STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH	HQC	1996-09-20
26884	1664523070	K960024	STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH	HQC	1996-09-20
26864	1605007209	K960009	STORZ S2050 SERIES BIPOLAR FORCEPS	GEI	1996-03-06
26868	1605007209	K960009	STORZ S2050 SERIES BIPOLAR FORCEPS	GEI	1996-03-06
26861	1827439812	K960007	STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	MPA	1996-03-26
26864	1827439812	K960007	STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	MPA	1996-03-26
26861	1012360895	K960003	STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION	HQC	1996-08-29
26864	1012360895	K960003	STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION	HQC	1996-08-29
26861	1730436553	K954340	STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE	HQC	1995-12-14
26864	1730436553	K954340	STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE	HQC	1995-12-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HQC	52	2026-03-25
LPL	46	2023-11-17
HQD	32	2019-02-12
MSS	24	2024-10-10
LPN	24	2022-12-06
MRC	13	2020-09-23
HQL	13	2008-09-26
LPM	11	2018-04-30
GEI	11	2009-06-26
MVN	10	2011-10-25
GEX	9	2014-07-15
LYX	6	2021-12-03
KYB	6	2007-11-01
NPL	5	2016-08-04
MPA	5	2015-09-11
FRO	4	2012-11-30
ONG	4	2012-04-02
LYL	4	2009-11-18
HQE	4	2002-04-29
LPM	4	1996-12-16
HBI	4	1991-04-19
GXI	4	1988-08-17
CAF	4	1987-10-06
LZP	3	2021-03-23
QPB	3	2011-06-23
MGQ	3	2009-03-27
HQF	3	2006-06-21
MRH	3	2000-01-07
POE	2	2022-07-22
LRX	2	2017-11-17
NPM	2	2017-07-18
MBI	2	2016-01-28
HQB	2	2013-06-26
LFD	2	2009-12-11
NUU	2	2004-06-07
HNO	2	2004-03-22
NAA	2	2003-11-14
HKY	2	2001-07-02
MUW	2	2001-02-16
MOE	2	1995-07-26

NDC#

Bryhali

Bausch Health US, LLC

halobetasol propionate

Cabtreo

Bausch Health US LLC

clindamycin phosphate/benzoyl peroxide/adapalene

Vaseretic

Bausch Health US, LLC

enalapril maleate and hydrochlorothiazide

ZELAPAR

Bausch Health US, LLC

SELEGILINE HYDROCHLORIDE

Duobrii

Bausch Health US, LLC

halobetasol propionate and tazarotene

WELLBUTRIN

Bausch Health US LLC

bupropion hydrochloride

WELLBUTRIN

Bausch Health US LLC

bupropion hydrochloride

Cardizem

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem CD

Bausch Health US LLC

diltiazem hydrochloride

Cardizem CD

Bausch Health US LLC

diltiazem hydrochloride

Cardizem CD

Bausch Health US LLC

diltiazem hydrochloride

Cardizem CD

Bausch Health US LLC

diltiazem hydrochloride

Cardizem CD

Bausch Health US LLC

diltiazem hydrochloride

Tetracaine Hydrochloride

Bausch Health US LLC

Tetracaine Hydrochloride

Cardizem LA

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem LA

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem LA

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem LA

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem LA

Bausch Health US LLC

Diltiazem Hydrochloride

Cardizem LA

Bausch Health US LLC

Diltiazem Hydrochloride

Syprine

Bausch Health US LLC

trientine hydrochloride

TIAZAC

Bausch Health US, LLC

diltiazem hydrochloride

200 records. Showing 1-40. Next

PMA#

Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters

2023-01-20

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 Supplem...

Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses

2022-09-29

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 ...

Akreos® Posterior Chamber Intraocular Lens (IOL)

2022-09-20

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 - Ma...

PMMA Anterior Chamber Intraocular Lenses

2022-08-09

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 - Manufact...

Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens

2022-06-01

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 ...

Bausch + Lomb PureVision® (balafilcon A) Visibility Tinted Soft Contact Lenses

2022-03-21

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 ...

Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses

2022-03-21

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 ...

SILSOFT (ELASTOFILCON A) CONTACT LENSES

2022-03-18

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 De...

SOFLENS 38(polymacon) Soft Contact Lens

2022-03-15

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 C...