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Data / Medical devices / United States / Bausch & Lomb Incorporated

Bausch & Lomb Incorporated: FDA-registered device maker in Manchester, MO, United States, 14 510(k) clearances

Bausch & Lomb Incorporated is registered with the FDA (registration 1932180) in Manchester, MO, United States. It lists 153 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 12, 2014. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Bausch & Lomb Incorporated
FDA registration number
1932180
FEI number
1000119305
Address
499 Sovereign CT., Manchester, MO, United States, 63011
Owner or operator
Bausch & Lomb Incorporated (9913003)
Roles
Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
February 22, 1989
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
AdenotomeKBH1Manufactureraccessdata.fda.gov
Applicator, EntKCJ1Manufactureraccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Manufactureraccessdata.fda.gov
Block, Cutting, Ent, SterileJXS1Manufactureraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Manufactureraccessdata.fda.gov
Burr, Corneal, ManualHOF1Manufactureraccessdata.fda.gov
Caliper, OphthalmicHOE1Manufactureraccessdata.fda.gov
Cannula, InjectionFGY1Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Manufactureraccessdata.fda.gov
Cannula, OphthalmicHMX1Manufactureraccessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalMXY1Manufactureraccessdata.fda.gov
Cannula, SinusKAM1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Repackager or relabeleraccessdata.fda.gov
Chisel, NasalKAN1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
Clamp, Eyelid, OphthalmicHOD1Manufactureraccessdata.fda.gov
Clamp, Muscle, OphthalmicHOB1Manufactureraccessdata.fda.gov
Clamp, Ossicle HoldingJYF1Manufactureraccessdata.fda.gov
Compressor, OrbitalHOA1Manufactureraccessdata.fda.gov
Conformer, OphthalmicHQN2Specification developeraccessdata.fda.gov
Crimper, Wire, Ent, SterileJXT1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Curette, AdenoidKBJ1Manufactureraccessdata.fda.gov
Curette, EarJYG1Manufactureraccessdata.fda.gov
Curette, NasalKAP1Manufactureraccessdata.fda.gov
Curette, OphthalmicHNZ1Manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
CystotomeHNY1Manufactureraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Manufactureraccessdata.fda.gov
Depressor, OrbitalHNX1Manufactureraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Manufactureraccessdata.fda.gov
Dilator, LachrymalHNW1Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Dissector, TonsilKBM1Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Elevator, EntKAD1Manufactureraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Manufactureraccessdata.fda.gov
Excavator, EarJYH1Manufactureraccessdata.fda.gov
ExpressorHNS1Manufactureraccessdata.fda.gov
Folders And Injectors, Intraocular Lens (Iol)MSS1Manufactureraccessdata.fda.gov
Forceps, EntKAE1Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufactureraccessdata.fda.gov
Forceps, Tube IntroductionBWB1Manufactureraccessdata.fda.gov
Forceps, Wire Closure, Ent, SterileJXX1Manufactureraccessdata.fda.gov
Fork, TuningGWX1Manufactureraccessdata.fda.gov
Gag, MouthKBN1Manufactureraccessdata.fda.gov
Gauge, Lens, OphthalmicHLN1Manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Manufactureraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Manufactureraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Guard, InstrumentLXZ1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
Holder, Speculum, EntKAG1Manufactureraccessdata.fda.gov
Hook, Microsurgical EarJYL1Manufactureraccessdata.fda.gov
Hook, OphthalmicHNQ1Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufactureraccessdata.fda.gov
Hook, TrachealKCH1Manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufactureraccessdata.fda.gov
Introducer, SphereHNP1Manufactureraccessdata.fda.gov
Knife, EarJYO1Manufactureraccessdata.fda.gov
Knife, EntKTG1Manufactureraccessdata.fda.gov
Knife, NasalKAS1Manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Knife, TonsilKBQ1Manufactureraccessdata.fda.gov
Laser, OphthalmicHQF2Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Manufacturer, Manufacturer for exportaccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Manufactureraccessdata.fda.gov
Marker, OcularHMR1Manufactureraccessdata.fda.gov
Marker, ScleraHMQ1Manufactureraccessdata.fda.gov
Microscope, Operating, Non-Electric, OphthalmicHRB1Specification developeraccessdata.fda.gov
Mirror, EntKAI1Manufactureraccessdata.fda.gov
Mirror, Headband, OphthalmicHKF1Manufactureraccessdata.fda.gov
Mobilizer, EntKAJ1Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Manufactureraccessdata.fda.gov
Needle, Gastro-UrologyFHR1Manufactureraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Manufactureraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Manufactureraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Manufactureraccessdata.fda.gov
Nipper, MalleusJYR1Manufactureraccessdata.fda.gov
Osteotome, ManualGFI1Manufactureraccessdata.fda.gov
Perforator, Ear-LobeJYS1Manufactureraccessdata.fda.gov
Pick, Microsurgical EarJYT1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
Press, VeinJYW1Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Probe, EntKAK1Manufactureraccessdata.fda.gov
Probe, LachrymalHNL1Manufactureraccessdata.fda.gov
Punch, AdenoidKBS1Manufactureraccessdata.fda.gov
Punch, AntrumKAW1Manufactureraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Manufactureraccessdata.fda.gov
Punch, EntKTF1Manufactureraccessdata.fda.gov
Punch, NasalKAY1Manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Manufactureraccessdata.fda.gov
Punch, TonsilKBT1Manufactureraccessdata.fda.gov
Rasp, EarJYY1Manufactureraccessdata.fda.gov
Rasp, NasalKBA1Manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Manufactureraccessdata.fda.gov
Razor, SurgicalLWK1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, EntKAL1Manufactureraccessdata.fda.gov
Retractor, OphthalmicHNI1Manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufactureraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Manufactureraccessdata.fda.gov
Scissors, EarJZB1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Scissors, NasalKBD1Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufactureraccessdata.fda.gov
Scissors, Wire Cutting, Ent, SterileJYA1Manufactureraccessdata.fda.gov
Set, Laryngeal InjectionKAA1Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Snare, EarJZD1Manufactureraccessdata.fda.gov
Snare, EnucleatingHNE1Manufactureraccessdata.fda.gov
Snare, NasalKBE1Manufactureraccessdata.fda.gov
Snare, TonsilKBZ1Manufactureraccessdata.fda.gov
Spatula, OphthalmicHND1Manufactureraccessdata.fda.gov
Spectacle, MagnifyingHOI1Manufactureraccessdata.fda.gov
Specula, OphthalmicHNC1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Manufactureraccessdata.fda.gov
Spoon, OphthalmicHNB1Manufactureraccessdata.fda.gov
Spud, OphthalmicHNA1Manufactureraccessdata.fda.gov
Staple, Removable (Skin)GDT1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stripper, SurgicalHRT1Manufactureraccessdata.fda.gov
Study, Platelet AdhesiveJBZ2Manufactureraccessdata.fda.gov
Syringe, EntKCP1Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufactureraccessdata.fda.gov
Tonometer, ManualHKY2Manufactureraccessdata.fda.gov
TrabeculotomeHMZ1Manufactureraccessdata.fda.gov
Tray, Surgical, EntMMO1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Manufactureraccessdata.fda.gov
Trocar, EntKTE1Manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Manufactureraccessdata.fda.gov
Tube, Ear SuctionJZF1Manufactureraccessdata.fda.gov
Tube, LaryngectomyKAC1Manufactureraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Repackager or relabeleraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov
Unit, PhacofragmentationHQC2Manufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 12, 2014K133486STELLARIS PC VISION ENHANCEMENT SYSTEMHQCSubstantially EquivalentBausch & Lombaccessdata.fda.gov
January 9, 2014K131958BAUSCH & LOMB INJECTOR SYSTEMMSSSubstantially EquivalentBausch & Lombaccessdata.fda.gov
December 19, 2006K063331BAUSCH & LOMB NGX MICROSURGICAL SYSTEMHQCSubstantially EquivalentBausch & Lomb, Inc.accessdata.fda.gov
December 17, 2003K033653VENTURI PHACO PACKHQCSubstantially EquivalentBausch & Lomb, Inc.accessdata.fda.gov
April 29, 2002K020911MID LABS AUTONOMOUS VIT ENHANCER (AVE)HQESubstantially EquivalentMedical Instrument Development Laboratories, Inc.accessdata.fda.gov
July 2, 2001K011199PROVIEW EYE PRESSURE MONITORHKYSubstantially EquivalentBausch & Lomb, Inc.accessdata.fda.gov
September 20, 1996K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHHQCSubstantially EquivalentStorz Instrument Co.accessdata.fda.gov
March 6, 1996K960009STORZ S2050 SERIES BIPOLAR FORCEPSGEISubstantially EquivalentStorz Instrument Co.accessdata.fda.gov
October 27, 1995K951463STORZ I/A HANDPIECESHQCSubstantially EquivalentStorz Instrument Co.accessdata.fda.gov
August 28, 1991K912739SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USEHQCSubstantially EquivalentSite Microsurgical Systems, Inc.accessdata.fda.gov
July 26, 1991K910957MASTERPIECES MICRO SYSTEMHRSSubstantially EquivalentStorz Instrument Co.accessdata.fda.gov
January 20, 1987K864402BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBEGEISubstantially EquivalentNew England Surgical Instrument Corp.accessdata.fda.gov
June 9, 1986K861825CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADEHRHSubstantially EquivalentStorz Instrument Co.accessdata.fda.gov
December 12, 1984K844004ESCHMANN TDB50 BIPOLAR COAGULATIONGEISubstantially EquivalentStorz Instrument Co.accessdata.fda.gov

Compare with other makers

Updated March 12, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.