Roseburg SA

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K931155STAPLE, FIXATION BONE; SCREW FIXATION BONESeptember 1, 1994
K890081CALIUS-ISABEL CANOVAS SUNGLASSESMarch 9, 1989
K885275ASSENAT-BLESCHET SUNGLASSESJanuary 24, 1989
K882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESAugust 26, 1988
K872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYDecember 7, 1987
K874317POIRIER KID-ROLLER MANUAL WHEELCHAIRNovember 17, 1987
K872714S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARYJuly 21, 1987
K871688SPECTACLE FRAME - DANIELLEMay 29, 1987
K871689SPECTACLE FRAME - LORRAINEMay 29, 1987
K870654EFER ARTHROSCOPEMay 14, 1987
K864436STAVIP 3000March 16, 1987
K864791POIRIER POWERED WHEELCHAIRFebruary 4, 1987
K864790POIRIER MANUAL WHEELCHAIRDecember 17, 1986
K860953SUNGLASSES (NON-PRESCRIPTION)October 24, 1986
K860955SPECTACLES LENSMarch 31, 1986
K860954SPECTACLES FRAMEMarch 31, 1986
K851560PORTASPIR IIDecember 13, 1985
K850294CANAL FINDERJune 4, 1985
K851555OPTHALMIC BAR PRISMMay 23, 1985
K851559TURQUOISEApril 30, 1985