Smith & Nephew Dyonics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K955914LIMITED REUSE ARTHROSCOPIC BLADESFebruary 8, 1996
K954627ECTRA II LIGAMENT RELEASE SYSTEMDecember 18, 1995
K954989DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADESNovember 27, 1995
K953695DYONICS DISPOSABLE ARTHROSCOPIC BLADESSeptember 15, 1995
K953387ECTRA LIGAMENT RELEASE SYSTEMAugust 9, 1995
K945182DYONICS FIXATION SCREWSJanuary 24, 1995
K936071SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPEAugust 19, 1994
K934299DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATIONFebruary 14, 1994
K920267DYONICS ARTHROSCOPIC KITMarch 23, 1993
K922176INTELIJET SUCTION SUPPLYNovember 18, 1992
K914963SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SETJune 4, 1992
K913401SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROLMarch 6, 1992
K914559SMALL JOINT SYSTEMFebruary 18, 1992
K914919SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEMJanuary 9, 1992
K913347PALMER ARCH SUPPRESSORSeptember 18, 1991
K912453INTELIJET TM FLUID MANAGEMENT SYSTEMAugust 26, 1991
K904284ARTHROSCOPIC SURGICAL BLADEDecember 5, 1990
K903620MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEMOctober 12, 1990
K903193SMITH & NEPHEW DYONICS LEVELERT SYSTEMAugust 30, 1990
K901765POSTEROMEDIAL GUIDEJune 25, 1990