ClearanceBrief
Company ยท US

Gulden Ophthalmics

FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 1997. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
13recalls that name a 510(k)

Product codes

CodeDeviceRecords
HQXImplant, Orbital, Extra-Ocular13
HPZImplant, Eye Sphere1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 3, 1997K972661EYE SPHERE, CONFORMERS
Gulden Ophthalmics
HPZ

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 5, 2003Gulden Ophthalmics
Conformer - Large with holes (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Conformer - Medium with holes (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Conformer - Small with holes (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Conformer - Large (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Conformer - Medium (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Conformer - Small (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Venus Eye Sphere 22 mm (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Venus Eye Sphere 20 mm (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Venus Eye Sphere 18 mm (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Venus Eye Sphere 16 mm (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Venus Eye Sphere 14 mm (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Venus Eye Sphere 12 mm (Sterile)
Terminated
HQXK972661
Feb 5, 2003Gulden Ophthalmics
Venus Eye sphere 10 mm (Sterile)
Terminated
HQXK972661
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