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Manufacturers
Gulden Ophthalmics
Manufacturer Address
Gulden Ophthalmics, 225 Cadwalader Ave, Elkins Park PA 19027-2020
Source
USFDA
13 Events
Recall of Device Recall Conformer Medium with holes (sterile)
Recall of Device Recall Conformer Medium with holes (sterile)
Recall of Device Recall Conformer Small with holes (sterile)
Recall of Device Recall Conformer Large (sterile)
Recall of Device Recall Conformer Medium (sterile)
Recall of Device Recall Conformer Small (sterile)
Recall of Device Recall Venus Eye Sphere 22 mm (sterile)
Recall of Device Recall Venus Eye Sphere 20 mm (sterile)
Recall of Device Recall Venus Eye Sphere 18 mm (sterile)
Recall of Device Recall Venus Eye Sphere 16 mm (sterile)
Recall of Device Recall Venus Eye Sphere 14 mm (sterile)
Recall of Device Recall Venus Eye Sphere 12 mm (sterile)
Recall of Device Recall Venus Eye Sphere 10 mm (sterile)
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13 devices in the database
Device Recall Conformer Medium with holes (sterile)
Model / Serial
model number 14169. lot number 1235
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
Product Description
Conformer - Large with holes (Sterile)
Device Recall Conformer Medium with holes (sterile)
Model / Serial
model number 14168. lot number 1234
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
Product Description
Conformer - Medium with holes (Sterile)
Device Recall Conformer Small with holes (sterile)
Model / Serial
model number 14167. lot number 1233
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
Product Description
Conformer - Small with holes (Sterile)
Device Recall Conformer Large (sterile)
Model / Serial
model number 14166. lot number 1218
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
Product Description
Conformer - Large (Sterile)
Device Recall Conformer Medium (sterile)
Model / Serial
model number 14165. lot number 1187
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
Product Description
Conformer - Medium (Sterile)
8 more
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