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Mani, Inc. - Kiyohara Facility

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and recall (Z-1468-2023)Mani, Inc. - Kiyohara Facility2023-04-26
MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, pack recall (Z-0649-2012)Mani, Inc. - Kiyohara Facility2012-01-11
MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, pack recall (Z-0650-2012)Mani, Inc. - Kiyohara Facility2012-01-11
MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, pack recall (Z-0651-2012)Mani, Inc. - Kiyohara Facility2012-01-11
MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, pack recall (Z-0652-2012)Mani, Inc. - Kiyohara Facility2012-01-11
MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, pack recall (Z-0653-2012)Mani, Inc. - Kiyohara Facility2012-01-11
MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, pack recall (Z-0654-2012)Mani, Inc. - Kiyohara Facility2012-01-11

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Every clearance here is in the API, with alerts when new ones post.