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Devices
Device Recall AUTO REF/KERATOMETER ARK1s
Model / Serial
Model No. ARK-1s, Serial No. 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 620370, 620371, 620374, 620376, 620377, 620380, 620381, 620384, 620387, 620389, 620391, 620394, 620398, 620400, 620403, 620404, 620407, 620410, 620412, 620415, 620417, 620418, 620420, 620422, 620425, 620427, 620429, 620433, 620435, 620437, 620440, 620444, 620445, 620447, 620450, 620452, 620454, 620455, 620459, 620462, 620464, 620466, 620469, 620471, 620474, 620477, 620478, 620480, 620482, 620485, 620487, 620489.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.
Product Description
AUTO REF/KERATOMETER ARK-1s
Manufacturer
Nidek Inc.
1 Event
Recall of Device Recall AUTO REF/KERATOMETER ARK1s
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Manufacturer
Nidek Inc.
Manufacturer Address
Nidek Inc., 47651 Westinghouse Dr, Fremont CA 94539-7474
Manufacturer Parent Company (2017)
Nidek Co. Ltd.
Source
USFDA
Language
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