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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 Conformer Medium with holes (sterile)
Rappel de Device Recall Conformer Medium with holes (sterile)
Rappel de Device Recall Conformer Small with holes (sterile)
Rappel de Device Recall Conformer Large (sterile)
Rappel de Device Recall Conformer Medium (sterile)
Rappel de Device Recall Conformer Small (sterile)
Rappel de Device Recall Venus Eye Sphere 22 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 20 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 18 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 16 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 14 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 12 mm (sterile)
Rappel de Device Recall Venus Eye Sphere 10 mm (sterile)
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13 dispositifs dans la base de données
Device Recall Conformer Medium with holes (sterile)
Modèle / numéro de série
model number 14169. lot number 1235
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 with holes (Sterile)
Device Recall Conformer Medium with holes (sterile)
Modèle / numéro de série
model number 14168. lot number 1234
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 with holes (Sterile)
Device Recall Conformer Small with holes (sterile)
Modèle / numéro de série
model number 14167. lot number 1233
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 with holes (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)
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)
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