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Mitek Products

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K013572MITEK BIOCRYL INTERFERENCE SCREWSMarch 14, 2002
K013781RIDIDFIX 2.7MM BTB CROSS PIN KITFebruary 6, 2002
K002639BIOKNOTLESS ANCHORMay 11, 2001
K010633RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEMMay 9, 2001
K002406MITEK 2GII MENISCAL REPAIR SYSTEMFebruary 15, 2001
K003076MITEK CUFFTACKOctober 27, 2000
K002422VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEMAugust 31, 2000
K002402VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEMAugust 31, 2000
K000936VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEMApril 19, 2000
K993575RESOLVE QUICKANCHORDecember 29, 1999
K993327TALON ANCHOR SNAP-PAKDecember 16, 1999
K993261TALON ANCHOR SNAP-PAKDecember 2, 1999
K992623MITEK MINI ANCHORNovember 2, 1999
K992876VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMSeptember 24, 1999
K992611MITEK ROTATOR CUFF QUICKANCHOR PLUSSeptember 22, 1999
K992487MITEK MINI QUICKANCHOR PLUSSeptember 21, 1999
K992406VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMAugust 6, 1999
K983818MITEK FASTIN RC ANCHORNovember 23, 1998
K982420MITEK MICRO ANCHORAugust 24, 1998
K974341MITEK BTB ABSORBABLE (PLA) CROSS PINApril 16, 1998