Bausch Lomb G M B H

FDA Filings

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

FDA Filings

Device Company	Device	Date
GUDID 04058935000653 Bausch & Lomb GmbH	PPT CRYSTALENS 12/BX PPT051	2019-11-08
GUDID 04058935000646 Bausch & Lomb GmbH	PPT MICS 6/BX PPT049	2019-11-08
GUDID 04058935000639 Bausch & Lomb GmbH	ZERO PHACO HP 2.2 30D STEL.12B SUP04ST	2019-10-07
GUDID 04058935000622 Bausch & Lomb GmbH	ZERO PHACO HDP 2.2MM 30D 12B SUP04	2019-10-07
GUDID 04058935000615 Bausch & Lomb GmbH	ZERO PHACO HDP 30DEG 12/B SUP03	2019-10-07
GUDID 04058935000523 Bausch & Lomb GmbH	MICS SIL I/A HDP 45° STELL 1/B 85915ST EA	2019-10-07
GUDID 04058935000516 Bausch & Lomb GmbH	MICS SIL I/A HDP 45° STELL 12B 85915ST	2019-10-07
GUDID 04058935000509 Bausch & Lomb GmbH	MICS SILICONE I/A HDPC 45° 1/B 85915S EA	2019-10-07
GUDID 04058935000493 Bausch & Lomb GmbH	MICS SILICONE I/A HDPC 45° 12/B 85915S	2019-10-07
GUDID 04058935000486 Bausch & Lomb GmbH	MICS I/A SIL.TIP STRT STEL 12B 85914ST	2019-10-07
GUDID 04058935000479 Bausch & Lomb GmbH	MICS I/A SIL.TIP STRT STEL 1/B 85914ST EA	2019-10-07
GUDID 04058935000462 Bausch & Lomb GmbH	MICS I/A SIL.TIP STRT MILL 1/B 85914S EA	2019-10-07
GUDID 04058935000455 Bausch & Lomb GmbH	MICS I/A SIL.TIP STRT MILL 12B 85914S	2019-10-07
GUDID 04058935000448 Bausch & Lomb GmbH	SIL I/A HANDP CURVED STELL 1/B 85913ST EA	2019-10-07
GUDID 04058935000431 Bausch & Lomb GmbH	SILICONE I/A HANDP CURVED 1/B 85913S EA	2019-10-07
GUDID 04058935000424 Bausch & Lomb GmbH	SILICONE I/A HANDP CURVED 12/B 85913S	2019-10-07
GUDID 04058935000417 Bausch & Lomb GmbH	I/A HDP.SIL.TIP STRT.STEL 12/B 85912ST	2019-10-07
GUDID 04058935000400 Bausch & Lomb GmbH	I/A HDP.SIL.TIP STRT.STEL 1/B 85912ST EA	2019-10-07
GUDID 04058935000394 Bausch & Lomb GmbH	I/A HDP.SIL.TIP STRGHT.MILL 12B 85912S	2019-10-07
GUDID 04058935000387 Bausch & Lomb GmbH	I/A HDP.SIL.TIP STRGHT.MILL 1/B 85912S EA	2019-10-07
GUDID 04058935000370 Bausch & Lomb GmbH	SIL. COATED I/A 45 STELLARIS 1/B 85910ST EA	2019-10-07
GUDID 04058935000363 Bausch & Lomb GmbH	SIL. COATED I/A 45 STELLARIS 12/B 85910ST	2019-10-07
GUDID 04058935000356 Bausch & Lomb GmbH	SIL. COATED I/A 45 MIL 1/B 85910S EA	2019-10-07
GUDID 04058935000349 Bausch & Lomb GmbH	SIL. COATED I/A 45 MIL 12/B 85910S	2019-10-07
GUDID 04058935000332 Bausch & Lomb GmbH	CHOPPER IRR END-OUT 19G 12/B 85903ST19	2019-10-07
GUDID 04058935000325 Bausch & Lomb GmbH	IRR CHOPPER END-OUT 20G 12/BOX 85903S20	2019-10-07
GUDID 04058935000318 Bausch & Lomb GmbH	IRR CHOPPER END-OUT 19G 12/BOX 85903S19	2019-10-07
GUDID 04058935000301 Bausch & Lomb GmbH	IRR. HANDPIECE SMOOTH 19G 12/B 85902ST19	2019-10-07
GUDID 04058935000295 Bausch & Lomb GmbH	IRR HANDPIECE SMOOTH,20G,12/BX 85902S20	2019-10-07
GUDID 04058935000288 Bausch & Lomb GmbH	IRR HANDPIECE SMOOTH,19G,12/BX 85902S19	2019-10-07
GUDID 04058935000271 Bausch & Lomb GmbH	ASP HANDPIECE 20G 12/BOX 85901S20	2019-10-07
GUDID 04058935000264 Bausch & Lomb GmbH	ASP HANDPIECE 19G 12/BOX 85901S19	2019-10-07
GUDID 04058935000257 Bausch & Lomb GmbH	ASP HPC STERILE LAT.PORT 12/BX 85900S	2019-10-07
GUDID 04058935000240 Bausch & Lomb GmbH	23G IRR HP SMOOTH STELL 12B 85807ST	2019-10-07
GUDID 04058935000233 Bausch & Lomb GmbH	23G IRR HANDPIECE SMOOTH 12B 85807S	2019-10-07
GUDID 04058935000226 Bausch & Lomb GmbH	22G IRR HP SMOOTH STELL 12B 85806ST	2019-10-07
GUDID 04058935000219 Bausch & Lomb GmbH	22G IRR HANDPIECE SMOOTH 12B 85806S	2019-10-07
GUDID 04058935000202 Bausch & Lomb GmbH	I/A HDP. 45 W SLEEVE 1.8 12/BX 85795ST	2019-10-07
GUDID 04058935000196 Bausch & Lomb GmbH	I/A HNDPC.CVD.W/SLEEVE 1.8 12/B 85794ST	2019-10-07
GUDID 04058935000189 Bausch & Lomb GmbH	23G ASP HANDPIECE ROUGH 12/BOX 85792S	2019-10-07
GUDID 04058935000172 Bausch & Lomb GmbH	23G IRR HANDPIECE END-OUT 12/B 85791S	2019-10-07
GUDID 04058935000165 Bausch & Lomb GmbH	ASP HANDPIECE 22G ROUGH 12/BOX 85790S	2019-10-07
GUDID 04058935000158 Bausch & Lomb GmbH	IRR HANDPIECE 22G END-OUT 12/B 85789S	2019-10-07
GUDID 04058935000141 Bausch & Lomb GmbH	IRR.HANDPIECE CENTR.PORT 12/BX 85788S	2019-10-07
GUDID 04058935000134 Bausch & Lomb GmbH	IRR. HANDPIECE SMOOTH 12/BX 85787ST	2019-10-07
GUDID 04058935000127 Bausch & Lomb GmbH	IRR HANDPIECE SMOOTH 12/BOX 85787S	2019-10-07
GUDID 04058935000110 Bausch & Lomb GmbH	I/A HANDPIECE90° ANG.16G 12/BX 85786ST	2019-10-07
GUDID 04058935000103 Bausch & Lomb GmbH	I/A HANDP.TIP 90DEG.16G.12BOX 85786S	2019-10-07
GUDID 04058935000097 Bausch & Lomb GmbH	I/A HANDP.STRAIG.W.SLEEVE 12BX 85785S	2019-10-07
GUDID 04058935000080 Bausch & Lomb GmbH	I/A HANDPIECE45° ANG.17G 12/BX 85784ST	2019-10-07
GUDID 04058935000073 Bausch & Lomb GmbH	I/A HANDP.TIP 45DEG.17G.12BOX 85784S	2019-10-07
GUDID 04058935000066 Bausch & Lomb GmbH	I/A HANDPIECE CURVED 17G 12/B 85783ST	2019-10-07
GUDID 04058935000059 Bausch & Lomb GmbH	I/A HANDP.CURVED,17G 12/BOX 85783S	2019-10-07
GUDID 04058935000042 Bausch & Lomb GmbH	I/A HANDP.STRAIGHT,17G 12/BOX 85782S	2019-10-07
GUDID 04058935000035 Bausch & Lomb GmbH	IRR HANDPIECE STERILE 12/BOX 85781S	2019-10-07
GUDID 04058935000028 Bausch & Lomb GmbH	ASP HANDPIECE STERILE 12/BOX 85780S	2019-10-07
GUDID 04058935000011 Bausch & Lomb GmbH	SIL I/A HANDP CURVED STELL 12/B 85913ST	2019-10-07
GUDID 04058935000660 Bausch & Lomb GmbH	Bipolar Pencil Tapered E7920	2018-10-29
GUDID 04058935000608 Bausch & Lomb GmbH	BIPOL.PEN 23G 2PIN TAPER 12/BX E7931	2018-10-29
GUDID 04058935000592 Bausch & Lomb GmbH	BIPOL.PEN 23G TPD LEMO 12/BX E7930	2018-10-29
GUDID 04058935000585 Bausch & Lomb GmbH	BIPOL.PEN 20GA LEMO 12/BX E7929	2018-10-29
GUDID 04058935000578 Bausch & Lomb GmbH	BIPOL.PEN SCLERAL LEMO 12/BX E7928	2018-10-29
GUDID 04058935000561 Bausch & Lomb GmbH	BIPOL.PEN 25G LEMO BLUNT 12BX E7927	2018-10-29
GUDID 04058935000554 Bausch & Lomb GmbH	BIPOL.PEN 25G LEMO TAPER 12BX E7926	2018-10-29
GUDID 04058935000547 Bausch & Lomb GmbH	BIPOL.PEN 25G 2PIN BLUNT 12/BX E7925	2018-10-29
GUDID 04058935000530 Bausch & Lomb GmbH	BIPOL.PEN 25G 2PIN TAPER 12/BX E7924	2018-10-29

Similar & Related FDA Registered Companies

• 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 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.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
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• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS024 Date Received06/11/2003 Decision Date08/13/2003 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS019 Date Received12/23/1998 Decision Date01/28/1999 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS016 Date Received10/31/1995 Decision Date05/01/1996 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS011 Date Received12/28/1988 Decision Date04/11/1990 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS009 Date Received12/19/1988 Decision Date04/11/1990 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS013 Date Received09/08/1989 Decision Date12/11/1989 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS001 Date Received02/20/1987 Decision Date10/17/1989 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Other Report Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS005 Date Received12/14/1987 Decision Date06/13/1989 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS007 Date Received05/17/1988 Decision Date03/02/1989 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS008 Date Received08/22/1988 Decision Date10/03/1988 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	C5176	BAUSCH & LOMB GMBH
CAGE Code	C5176	BAUSCH & LOMB GMBH