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Neometrics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K152560Bard Snare Retrieval KitOctober 23, 2015
K150225NovaGold High Performance GuidewireMarch 16, 2015
K143135Spring Coil GuidewireFebruary 20, 2015
K133076NOVAGOLD HIGH PERFORMANCE GUIDEWIREFebruary 20, 2014
K123439NEO ERCP GUIDEWIREJanuary 3, 2013
K101729NEOWIRE PTA/PTCA GUIDEWIRESeptember 23, 2010
K070150VASCUPUNCTURE PICC GUIDEWIREFebruary 15, 2007
K043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREMarch 1, 2005
K040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGApril 19, 2004
K033321SELECTIVA SB GUIDEWIRENovember 5, 2003
K031652VASCUPUNCTURE PICC GUIDEWIRESeptember 30, 2003
K012861VASCUPUNCTURE ACCESS WIREFebruary 5, 2002
K013024SELECTIVA GUIDEWIREDecember 4, 2001
K001455ACCUWELL TSH, MODEL KAW-TSH-960November 2, 2000
K991498ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGALJune 16, 1999
K974047ACCUWELL PHENYLALANINE ASSAYDecember 5, 1997
K972974ACCUWELL T4-EIAOctober 6, 1997
K934178ACCUSCREEN 17-HYDROXYPROGESTERONEMarch 30, 1995
K901939NEOCOAT T4May 31, 1990
K843281ACCUSCREEN TSHSeptember 26, 1984