Bausch & Lomb Incorporated

FDA Device Registration & Listing · Eppelheim Baden-Wurttemberg, DE · Registration 3029990829

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029990829
FEI Number
3029990829
Entity Name
Bausch & Lomb Incorporated
City/State/Country
Eppelheim Baden-Wurttemberg, DE
Establishment Address
Lilienthalstr. 16, 18, Eppelheim Baden-Wurttemberg 69214, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Bausch & Lomb Incorporated (Owner Number: 9913003)
Owner / Operator Contact Address
400 Somerset Corporate Blvd., --, Bridgewater, NJ 08807, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HMZ Trabeculotome Ophthalmic Class 1 886.4350 1993-01-01
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2005-08-29
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2008-08-04
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 1996-10-01
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 1993-01-01
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2010-07-23
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 1993-01-01
HNG Rongeur, Lachrymal Sac Ophthalmic Class 1 886.4350 1993-01-01
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01

Official Correspondent

Margaret Wood

US Agent Details

Margaret Wood Business: BAUSCH & LOMB INCORPORATED Email: FDADeviceReg@bausch.com Phone: (864) 3206017

Related Public Records

Same Entity

Bausch & Lomb Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1119279 Bausch & Lomb Incorporated CLEARWATER, FL, US
1920664 Bausch & Lomb Incorporated Saint Louis, MO, US
1032500 Bausch & Lomb Incorporated GREENVILLE, SC, US
3007583964 TOTAL TITANIUM, INC. Red Bud, IL, US
1281950 Bausch & Lomb Incorporated WILMINGTON, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23
K091915 Lenstec, Inc. FLUID ISOLATION DEVICE 2009-10-27
K830812 Alphamedix, Inc. ALPHAMEDIX I/A HAND-PIECE, 500-001 1983-06-08
K133115 Abbott Medical Optics, Inc. COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK 2014-02-27
K121721 Abbott Medical Optics, Inc. LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) 2012-10-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number Establishment Name Location
3013398127 SIHONG OPHSURIN CO., LTD Suqian Jiangsu, CN
3004748528 SHANGHAI JPY ION-TECH CO., LTD. SHANGHAI, CN
3012185136 RUMEX Baltics SIA Riga, LV
3003039352 EPSILON EYE CARE PVT., LTD. MUMBAI Maharashtra, IN
3008342610 SUQIAN ZHENGTONG MEDICAL INSTRUMENTS CO. LTD CHINA, HK
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029990829. Last updated year: 2026. Please use registration number 3029990829 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.