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Flexmedics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K990765FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHMarch 15, 1999
K964955FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFebruary 14, 1997
K952430FINESSE GUIDEWIRE CORONARYAugust 18, 1995
K943390FLEXFINDER GUIDEWIREJune 27, 1995
K942074FLEXFINDER GUIDEWIREJune 24, 1994
K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREJanuary 21, 1994
K912843FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBESeptember 24, 1991
K910674FLEXMEDICS MALLEABLE CANNULAApril 12, 1991
K895899FLEXMEDICS GUIDEWIRE .012 ONLYMay 23, 1990
K893626FLEXMEDICS GUIDEWIRESeptember 26, 1989
K885086TIN COATED NITI ORTHODONTIC ARCH WIRESJanuary 10, 1989
K883120FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRENovember 14, 1988
K881331ORTHODONTIC NITINOL SPRINGSApril 21, 1988
K881274CENTER BEND ARCH WIRESApril 12, 1988
K881233STRAIGHT LENGTH ARCH WIRESApril 12, 1988
K880882REVERSE CURVE ARCHWIREApril 11, 1988
K881163RECTANGULAR NITINOL ARCH WIREApril 7, 1988
K873649FLEX GOLDOctober 5, 1987
K870156FLEXMEDICS NITINOL MAMMORY WIREFebruary 24, 1987
K863742FLEXMEDICS NITINOL ARCH WIRENovember 24, 1986