FDA Registration
Active
🇺🇸 United States
Bausch & Lomb Incorporated
Reg #: 1932180
·
FEI: 1000119305
·
Expires 2026
Products
153
Proprietary Names
0
Establishment Types
4
Classifications
153
Registration Details
- Registration Name
- Bausch & Lomb Incorporated
- Registration Number
- 1932180
- FEI Number
- 1000119305
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 499 SOVEREIGN CT.
- City
- Manchester
- State
- MO
- ZIP
- 63011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K912739
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 |
|---|---|---|---|---|---|
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2023-07-18 |
| Holder, Speculum, Ent | KAG | Class 1 | General, Plastic Surgery | No | 1996-11-15 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2016-07-14 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 1996-10-25 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-02-11 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2025-01-27 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2004-08-10 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2025-08-15 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2014-03-07 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2025-08-04 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 1996-12-10 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2005-08-29 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 1997-01-08 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2025-04-29 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Expressor | HNS | Class 1 | Ophthalmic | No | 1993-01-01 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1996-09-09 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 1993-01-12 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1993-01-01 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 1996-12-09 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2018-04-05 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2018-04-05 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-01-31 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 1996-12-10 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2025-08-15 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1993-01-01 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2025-04-29 |
| Set, Laryngeal Injection | KAA | Class 1 | Ear, Nose, Throat | No | 2025-08-04 |
| Snare, Enucleating | HNE | Class 1 | Ophthalmic | No | 1993-01-01 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 1993-01-01 |
| Speculum, Non-Illuminated | FXE | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2024-03-11 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2013-02-08 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2005-05-26 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2005-08-29 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-03-22 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2025-08-04 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 2025-05-13 |
| Study, Platelet Adhesive | JBZ | Class 2 | Hematology | No | 2025-08-04 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Press, Vein | JYW | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2005-08-29 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2004-08-10 |
| Mobilizer, Ent | KAJ | Class 1 | Ear, Nose, Throat | No | 1996-10-25 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2006-05-12 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2004-08-10 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2025-08-04 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1993-01-01 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2008-01-15 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Block, Cutting, Ent, Sterile | JXS | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 1996-12-10 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Clamp, Ossicle Holding | JYF | Class 1 | Ear, Nose, Throat | No | 1996-10-01 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2010-12-04 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 1993-01-01 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 1997-01-08 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1996-10-01 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2005-08-29 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Microscope, Operating, Non-Electric, Ophthalmic | HRB | Class 1 | General, Plastic Surgery | No | 2014-12-16 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 1996-12-23 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 2025-08-15 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2023-05-18 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-02-01 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1996-12-09 |
| Guard, Instrument | LXZ | Class 1 | General, Plastic Surgery | No | 2025-08-15 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 1989-02-22 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 1993-01-01 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1993-01-12 |
| Scissors, Wire Cutting, Ent, Sterile | JYA | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2004-08-10 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2006-05-12 |
| Trabeculotome | HMZ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1993-01-12 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 1993-01-01 |
| Punch, Tonsil | KBT | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Perforator, Ear-Lobe | JYS | Class 1 | Ear, Nose, Throat | No | 2025-08-04 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2005-08-29 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2005-08-29 |
| Compressor, Orbital | HOA | Class 1 | Ophthalmic | No | 2025-07-29 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1996-10-25 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2019-05-20 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 1993-01-12 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2005-08-29 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 1996-11-05 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2013-02-01 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2013-02-01 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 1996-10-17 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2005-08-29 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 1996-10-01 |
| Crimper, Wire, Ent, Sterile | JXT | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1993-01-01 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1993-01-01 |
| Forceps, Wire Closure, Ent, Sterile | JXX | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1996-11-05 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 1993-01-01 |
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility