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Acufex Microsurgical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
78
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K961555ACUFEX TAG BIOABSORBABLE ANCHORSJuly 10, 1996
K961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERJune 21, 1996
K954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWFebruary 15, 1996
K952535ACUFEX ENDOBUTTON TAPEFebruary 8, 1996
K953276ACUFEX TAG DELIVERY SYSTEMOctober 5, 1995
K953459ACUFEX TAG ANCHORAugust 23, 1995
K941740ACUFEX ROTATOR CUFF FIXATION BUTTONJune 30, 1995
K944500ACUFEX PATELLAR BONE BLOCK SIZERJune 12, 1995
K951859ACUFEX ENDOBUTTON PACKJune 9, 1995
K946346ACUFEX TAG(R) BIOABSORBABLE ANCHORSApril 26, 1995
K941709ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMSApril 14, 1995
K943548BIOABSORBABLE INTERFERENCE SCREWMarch 20, 1995
K934867ACUFEX TAG ANCHORFebruary 9, 1995
K942442ACUFEX T-FIX DELIVERY SYSTEMDecember 5, 1994
K942834ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULASeptember 28, 1994
K942079MANUAL SURGICAL INSTRUMENTSSeptember 28, 1994
K940290ACUFEX ACL SHEATH FOR INTERFERENCE SCREWSSeptember 28, 1994
K942846ACUFEX(R) ENDO-FEMORAL AIMERSeptember 28, 1994
K942574GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDERSeptember 28, 1994
K933948ACUFEX ENDOBUTTON SYSTEMJuly 21, 1994