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Crédits
Manufacturers
Gulden Ophthalmics
Adresse du fabricant
Gulden Ophthalmics, 225 Cadwalader Ave, Elkins Park PA 19027-2020
Source
USFDA
13 Events
Rappel de Device Recall Venus Eye Sphere 20 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 22 mm (sterile)
Rappel de Device Recall Conformer Small (sterile)
Rappel de Device Recall Conformer Medium (sterile)
Rappel de Device Recall Conformer Large (sterile)
Rappel de Device Recall Conformer Small with holes (sterile)
Rappel de Device Recall Conformer Medium with holes (sterile)
Rappel de Device Recall Conformer Medium with holes (sterile)
Rappel de Device Recall Venus Eye Sphere 18 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 12 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 10 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 14 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 16 mm (sterile)
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13 dispositifs dans la base de données
Device Recall Venus Eye Sphere 20 mm (sterile)
Modèle / numéro de série
model number 14155. lot number 8404
Classification du dispositif
Ophthalmic Devices
Classe de dispositif
2
Dispositif implanté ?
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
Description du dispositif
Venus Eye Sphere 20 mm (Sterile)
Device Recall Venus Eye Sphere 22 mm (sterile)
Modèle / numéro de série
model number 14156. lot number 8447
Classification du dispositif
Ophthalmic Devices
Classe de dispositif
2
Dispositif implanté ?
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
Description du dispositif
Venus Eye Sphere 22 mm (Sterile)
Device Recall Conformer Small (sterile)
Modèle / numéro de série
model number 14164. lot number 8264B
Classification du dispositif
Ophthalmic Devices
Classe de dispositif
2
Dispositif implanté ?
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
Description du dispositif
Conformer - Small (Sterile)
Device Recall Conformer Medium (sterile)
Modèle / numéro de série
model number 14165. lot number 1187
Classification du dispositif
Ophthalmic Devices
Classe de dispositif
2
Dispositif implanté ?
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
Description du dispositif
Conformer - Medium (Sterile)
Device Recall Conformer Large (sterile)
Modèle / numéro de série
model number 14166. lot number 1218
Classification du dispositif
Ophthalmic Devices
Classe de dispositif
2
Dispositif implanté ?
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
Description du dispositif
Conformer - Large (Sterile)
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