Gulden Ophthalmics Inc

FDA Filings

This page includes the latest FDA filings for Gulden Ophthalmics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2518410
FEI Number2518410
NameGULDEN OPHTHALMICS
Owner & OperatorGULDEN OPHTHALMICS INC
Contact Address225 CADWALADER AVE. --
Elkins Park PA 19027 US
Official Correspondent
  • SEAN T COCKLEY
  • x-215-8848105-3
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address225 CADWALADER AVE.
Elkins Park, PA 19027 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Gulden Ophthalmics Inc.
22mm Eye Sphere (non-sterile) 141562023-07-27
Gulden Ophthalmics Inc.
20mm Eye Sphere (non-sterile) 141552023-07-27
Gulden Ophthalmics Inc.
18mm Eye Sphere (non-sterile) 141542023-07-27
Gulden Ophthalmics Inc.
16mm Eye Sphere (non-sterile) 141532023-07-27
Gulden Ophthalmics Inc.
14mm Eye Sphere (non-sterile) 141522023-07-27
Gulden Ophthalmics Inc.
12mm Eye Sphere (non-sterile) 141512023-07-27
Gulden Ophthalmics Inc.
10mm Eye Sphere (non-sterile) 141502023-07-27
Gulden Ophthalmics Inc.
Silicone Suction Cup (12 pk) 2023-07-13
Gulden Ophthalmics Inc.
Flashing Fixation Sticks (2pk) 2023-07-13
Gulden Ophthalmics Inc.
Opto Clip (2 pk) 2023-07-13
Gulden Ophthalmics Inc.
Face Fixation Sticks (3pk) 2023-07-13
Gulden Ophthalmics Inc.
Pediatric Fixation Sticks (3pk) 2023-07-13
Gulden Ophthalmics Inc.
Fixation Sticks (4pk) 2023-07-13
Gulden Ophthalmics Inc.
Pediatric Fixation Wand 2023-07-13
Gulden Ophthalmics Inc.
Flashing Butterfly Fixation Stick 2023-07-13
Gulden Ophthalmics Inc.
Color Fixation Sticks 2023-07-13
Gulden Ophthalmics Inc.
Retinoscopy Rack 2023-07-13
Gulden Ophthalmics Inc.
Retinoscopy Rack with Compass 2023-07-13
Gulden Ophthalmics Inc.
Brock String 2023-07-13
Gulden Ophthalmics Inc.
Peds Pack 2023-07-13
Gulden Ophthalmics Inc.
Clip-on Spielmann 2023-07-13
Gulden Ophthalmics Inc.
Clip-on Occluder 2023-07-13
Gulden Ophthalmics Inc.
Clip-on Multiple Pinhole Occluder 2023-07-13
Gulden Ophthalmics Inc.
Tangent Screen 2023-07-13
Gulden Ophthalmics Inc.
Dix Magnetic Foreign Body Remover 2022-12-06
Gulden Ophthalmics Inc.
Ellis Magnetic Foreign Body Remover 161082022-12-06
Gulden Ophthalmics Inc.
Luedde Exophthalmometer 2022-12-06
Gulden Ophthalmics Inc.
Jaeger Lid Plate 161022022-12-06
Gulden Ophthalmics Inc.
Orbital Implant Sizer Kit 141702022-12-06
Gulden Ophthalmics Inc.
Schioetz Tonometer - Allen Wrench Modification 131102018-07-06
Gulden Ophthalmics Inc.
Schioetz Tonometer 131072018-07-06
Gulden Ophthalmics Inc.
Silicone Eye Sphere - 22mm 143562018-03-29
Gulden Ophthalmics Inc.
Silicone Eye Sphere - 20mm 143552018-03-29
Gulden Ophthalmics Inc.
Silicone Eye Sphere - 18mm 143542018-03-29
Gulden Ophthalmics Inc.
Silicone Eye Sphere - 16mm 143532018-03-29
Gulden Ophthalmics Inc.
Silicone Eye Sphere - 14mm 143522018-03-29
Gulden Ophthalmics Inc.
Silicone Eye Sphere - 12mm 143512018-03-29
Gulden Ophthalmics Inc.
Symblepharon Ring - 24mm 143472018-03-29
Gulden Ophthalmics Inc.
Symblepharon Ring - 22mm 143462018-03-29
Gulden Ophthalmics Inc.
Symblepharon Ring - 20mm 143452018-03-29
Gulden Ophthalmics Inc.
Large Sterile Eye Conformer with Holes (PMMA) 142692018-03-29
Gulden Ophthalmics Inc.
Medium Sterile Eye Conformer with Holes (PMMA) 142682018-03-29
Gulden Ophthalmics Inc.
Small Sterile Eye Conformer with Holes (PMMA) 142672018-03-29
Gulden Ophthalmics Inc.
Large Sterile Eye Conformer (PMMA) 142662018-03-29
Gulden Ophthalmics Inc.
Medium Sterile Eye Conformer (PMMA) 142652018-03-29
Gulden Ophthalmics Inc.
Small Sterile Eye Conformer (PMMA) 142642018-03-29
Gulden Ophthalmics Inc.
22mm Sterile Orbital Implant (PMMA) 142562018-03-29
Gulden Ophthalmics Inc.
20mm Sterile Orbital Implant (PMMA) 142552018-03-29
Gulden Ophthalmics Inc.
18mm Sterile Orbital Implant (PMMA) 142542018-03-29
Gulden Ophthalmics Inc.
16mm Sterile Orbital Implant (PMMA) 142532018-03-29
Gulden Ophthalmics Inc.
14mm Sterile Orbital Implant (PMMA) 142522018-03-29
Gulden Ophthalmics Inc.
12mm Sterile Orbital Implant (PMMA) 142512018-03-29
Gulden Ophthalmics Inc.
10mm Sterile Orbital Implant (PMMA) 142502018-03-29
Gulden Ophthalmics Inc.
Large Conformer with Holes (non-sterile) 141692018-03-29
Gulden Ophthalmics Inc.
Medium Conformer with Holes (non-sterile) 141682018-03-29
Gulden Ophthalmics Inc.
Small Conformer with Holes (non-sterile) 141672018-03-29
Gulden Ophthalmics Inc.
Large Conformer (non-sterile) 141662018-03-29
Gulden Ophthalmics Inc.
Medium Conformer (non-sterile) 141652018-03-29
Gulden Ophthalmics Inc.
Small Conformer (non-sterile) 141642018-03-29
Gulden Ophthalmics Inc.
22mm Eye Sphere (non-sterile) 141562018-03-29
Gulden Ophthalmics Inc.
20mm Eye Sphere (non-sterile) 141552018-03-29
Gulden Ophthalmics Inc.
18mm Eye Sphere (non-sterile) 141542018-03-29
Gulden Ophthalmics Inc.
16mm Eye Sphere (non-sterile) 141532018-03-29
Gulden Ophthalmics Inc.
14mm Eye Sphere (non-sterile) 141522018-03-29
Gulden Ophthalmics Inc.
12mm Eye Sphere (non-sterile) 141512018-03-29
Gulden Ophthalmics Inc.
10mm Eye Sphere (non-sterile) 141502018-03-29
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Shade Selection Kit2017-04-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Gulden Tear Test Strips2017-04-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Pediatric Trial Frame, Child Trial Frame, Universal Trial Frame, Universal Trial Frame Lightweight2017-04-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Felt Tangent Screen2017-04-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Meibomian Gland Expressor Kit2017-04-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Maddox Phoria Measure2017-04-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Orbital Sizer Kit2017-04-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Durette External Shield2016-08-31
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
COX II Laser Shield2016-08-31
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Tiemann2016-08-31
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Jaeger2016-08-31
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Desmarres2016-08-31
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Gulden Distometer2014-03-25
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Aurosling2013-07-30
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Gulden Eye Spheres2007-11-08
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
VARIOUS PLASLTIC EYE CONFORMERS2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
CONFORMER2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
trial Lenses, Universal, Light Weight, Child & Pediatric Trail Frames, Raff Level Trial Flipper,Maddox Trial Lens w/Hand2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
OPTO CLIP2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
BERENS CLIP-ON PRISMS2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
LUEDDE2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
R-502004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
BERENS ACCOMMODATION RULE2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
MADDOX2004-06-28
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
OPTOKINETIC FLAG2004-02-05
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
VARIOUS COLOR VISION TESTERS2004-02-05
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
FARNSWORTH LANTERN FLASHLIGHT2004-02-05
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
CLARK NLD CANNULA2001-02-16
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
SIEPSER DIGITAL PUPILLOMETER2001-02-16
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
FIXATION STICKS1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
AMSLER GRID1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Spud Dix & Ellis Style1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
SKIASCOPIC RACK1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
FUSION AND STEROSCOPIC TARGETS1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
SAFE (STEREOPSIS1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
FUSION EVALUATOR)1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
LOW VISION MAGNIFIER1999-03-02
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
TEST1995-03-21
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
SPECTACLE DISSOCIATION1995-03-21
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
BATTERY-POWERED (LANCASTER)1995-03-21
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
VISUAL ACUITY1993-11-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
CHART1993-11-10
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
VARIOUS PLASTIC EYE SHIELDS1992-08-26
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
Plastic Desmarres, Jaeger Lid1992-08-26
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
PRISM BAR1992-08-26
GULDEN OPHTHALMICS [GULDEN OPHTHALMICS INC]
BERENS PRISMS1992-08-26

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