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Data / Medical devices / United States / Gulden Ophthalmics

Gulden Ophthalmics: FDA-registered device maker in Elkins Park, PA, United States, 1 510(k) clearance

Gulden Ophthalmics is registered with the FDA (registration 2518410) in Elkins Park, PA, United States. It lists 35 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 3, 1997. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Gulden Ophthalmics
FDA registration number
2518410
Address
225 Cadwalader Ave., Elkins Park, PA, United States, 19027
Owner or operator
GULDEN OPHTHALMICS INC (2518410)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
August 26, 1992
Registered through
2026
Brand names listed
10mm Eye Sphere (Sterile), 10mm Eye Sphere (non-sterile), 12mm Eye Sphere (Sterile), 12mm Eye Sphere (non-sterile), 14mm Eye Sphere (Sterile), 14mm Eye Sphere (non-sterile), 16mm Eye Sphere (Sterile), 16mm Eye Sphere (non-sterile) and more

Devices it lists

DeviceProduct codeClassRoleSource
Chart, Visual AcuityHOX1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Clip, Lens, Trial, OphthalmicHPB1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Conformer, OphthalmicHQN2Complaint file establishment, Manufactureraccessdata.fda.gov
Device, Fixation, Ac-Powered, OphthalmicHPL1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
DistometerHMM1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Drum, OpticokineticHOW1Repackager or relabeleraccessdata.fda.gov
ExophthalmometerHLS1Manufactureraccessdata.fda.gov
Fixation, Vision Training, BinocularNXR1Manufactureraccessdata.fda.gov
Frame, Trial, OphthalmicHPA1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Grid, AmslerHOQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Implant, Eye SphereHPZ2Manufactureraccessdata.fda.gov
Inserter/Remover Contact LensKYE1Repackager or relabeleraccessdata.fda.gov
Instrument, Measuring, StereopsisHLC1Manufactureraccessdata.fda.gov
Lens, MaddoxHKR1Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Magnifier, Hand-Held, Low-VisionHJF1Repackager or relabeleraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Complaint file establishmentaccessdata.fda.gov
Perimeter, ManualHON1Manufactureraccessdata.fda.gov
Prism, Bar, OphthalmicHKW1Manufactureraccessdata.fda.gov
Prism, Rotary, OphthalmicHKQ1Manufactureraccessdata.fda.gov
Pupillometer, ManualHLH1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Rack, SkiascopicHMH1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Complaint file establishment, Manufactureraccessdata.fda.gov
Ruler, Nearpoint (Punctometer)HLE1Manufactureraccessdata.fda.gov
Screen, Tangent, Felt (Campimeter)HOL1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Shield, Eye, RadiologicalIWS1Complaint file establishmentaccessdata.fda.gov
Simulatan (Including Crossed Cylinder)HOR1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Spud, OphthalmicHNA1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Complaint file establishment, Manufactureraccessdata.fda.gov
Tape, NystagmusHKD1Repackager or relabeleraccessdata.fda.gov
Target, Fusion And StereoscopicHLP1Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Spectacle Dissociation, Battery-Powered (Lancaster)HLO1Manufactureraccessdata.fda.gov
Tester, Color VisionHIT1Complaint file establishment, Manufactureraccessdata.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
October 3, 1997K972661EYE SPHERE, CONFORMERSHPZSubstantially EquivalentGulden Ophthalmicsaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
February 5, 201054633Not yet classifiedTerminatedImage Consultant (IC) SoftwareSoftware not validated; inaccurate results may occur.accessdata.fda.gov
November 29, 200225123Not yet classifiedTerminatedVenus Eye Sphere 12 mm (Sterile)lack of sterility assuranceaccessdata.fda.gov

Compare with other makers

Updated March 22, 2010. 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.