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FDA 510(k) Applications Submitted by CAROLYN M STEELE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K960014
01/02/1996
PRACTIFIX EXTERNAL FIXATION SYSTEM
ORTHOPAEDIC INNOVATIONS, INC.
K955620
12/11/1995
PRIME CEMENTED CALCAR FEMORAL STEMS
ORTHOPAEDIC INNOVATIONS, INC.
K955751
12/20/1995
PRIME FEMORAL CEMENT PLUG
ORTHOPAEDIC INNOVATIONS, INC.
K970307
01/27/1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
EMPI
K972054
06/02/1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
EMPI
K983206
09/14/1998
SMALL VAGINAL/RECTAL ELECTRODE
EMPI
K983484
10/05/1998
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
EMPI
K964577
11/14/1996
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)
EMPI
K971527
04/28/1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
EMPI
K962646
07/08/1996
PRIME MODULAR ENDO HEAD
ORTHOPAEDIC INNOVATIONS, INC.
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