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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 3 of 3 Results
PMA Number: P970053
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Product Description
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FDA Recall
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Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excime... 2 03/20/2017 Nidek Inc
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: N... 2 06/04/2015 Nidek Inc
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is co... 2 11/17/2014 Nidek Inc