Gulden Ophthalmics
Elkins Park, PA, US
GULDEN OPHTHALMICS appears in FDA device records in Elkins Park, PA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Gulden Ophthalmics carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- R.O. Gulden & Co., Inc.recall
510(k) clearance history
FDA records hold 1 510(k) clearance for Gulden Ophthalmics in 1997.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518410 | 2518410 | GULDEN OPHTHALMICS | 225 CADWALADER AVE., Elkins Park, PA 19027 US | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HOXChart, Visual Acuity
- HPBClip, Lens, Trial, Ophthalmic
- HQNConformer, Ophthalmic
- HPLDevice, Fixation, Ac-Powered, Ophthalmic
- KYXDispenser, Liquid Medication
- HMMDistometer
- HOWDrum, Opticokinetic
- HLSExophthalmometer
- NXRFixation, Vision Training, Binocular
- HPAFrame, Trial, Ophthalmic
- HOQGrid, Amsler
- HPZImplant, Eye Sphere
- KYEInserter/Remover Contact Lens
- HLCInstrument, Measuring, Stereopsis
- HKRLens, Maddox
- KYTLight, Examination, Medical, Battery Powered
- HJFMagnifier, Hand-Held, Low-Vision
- HNMNeedle, Ophthalmic Suturing
- HONPerimeter, Manual
- HKWPrism, Bar, Ophthalmic
- HKQPrism, Rotary, Ophthalmic
- HLHPupillometer, Manual
- HMHRack, Skiascopic
- HNIRetractor, Ophthalmic
- HLERuler, Nearpoint (Punctometer)
- HOLScreen, Tangent, Felt (Campimeter)
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- IWSShield, Eye, Radiological
- HORSimulatan (Including Crossed Cylinder)
- HNASpud, Ophthalmic
- FTYTape, Measuring, Rulers And Calipers
- HKDTape, Nystagmus
- HLPTarget, Fusion And Stereoscopic
- HLOTest, Spectacle Dissociation, Battery-Powered (Lancaster)
- HITTester, Color Vision
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1176-2010 | Image Consultant (IC) Software | Software not validated; inaccurate results may occur. | Terminated | ||
| Z-0539-03 | Conformer - Large with holes (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0538-03 | Conformer - Medium with holes (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0537-03 | Conformer - Small with holes (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0536-03 | Conformer - Large (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0535-03 | Conformer - Medium (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0534-03 | Conformer - Small (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0533-03 | Venus Eye Sphere 22 mm (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0532-03 | Venus Eye Sphere 20 mm (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0531-03 | Venus Eye Sphere 18 mm (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0530-03 | Venus Eye Sphere 16 mm (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0529-03 | Venus Eye Sphere 14 mm (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0528-03 | Venus Eye Sphere 12 mm (Sterile) | lack of sterility assurance | Terminated | ||
| Z-0540-03 | Venus Eye sphere 10 mm (Sterile) | lack of sterility assurance | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Gulden Ophthalmics edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain