FDA Registration
Active
🇺🇸 United States
Bausch & Lomb Incorporated
Reg #: 1920664
·
FEI: 1920664
·
Expires 2026
Products
27
Proprietary Names
0
Establishment Types
4
Classifications
27
Registration Details
- Registration Name
- Bausch & Lomb Incorporated
- Registration Number
- 1920664
- FEI Number
- 1920664
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3365 TREE CT. INDUSTRIAL BLVD.
- City
- Saint Louis
- State
- MO
- ZIP
- 63122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141379
- PMA Number
- P990027
Owner / Operator
- Firm Name
- Bausch & Lomb Incorporated
- Operator Number
- 9913003
- Address
- 400 Somerset Corporate Blvd., --
- City
- Bridgewater
- State
- NJ
- Postal Code
- 08807
- Country
- US
- Correspondent
- Margaret Wood
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2015-06-09 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2008-01-16 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2008-01-16 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Media, Corneal Storage | LYX | Class U | Unknown | No | 2016-07-27 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-09-24 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2008-01-24 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2009-03-26 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2015-06-09 |
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2006-02-13 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2024-10-14 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1996-11-05 |
| Aberrometer, Ophthalmic | NCF | Class 1 | Ophthalmic | No | 2002-04-12 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2005-08-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2017-05-08 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2005-08-29 |
| Collagen Corneal Shield | MOE | Class 1 | Ophthalmic | No | 2006-02-13 |
| Pump, Infusion, Ophthalmic | MRH | Class 2 | General Hospital | No | 2024-08-12 |
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2008-01-24 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2023-07-18 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 1993-01-01 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2008-01-15 |
| Excimer Laser System | LZS | Class 3 | Unknown | No | 2007-12-20 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 1996-12-10 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 1996-10-01 |
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility