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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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Decision
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impax diagnostic display station,impax clinical review station,impax for cardiology clinical review satation,impax ortho AGFA CORP. k022292 09/12/2002
g-rinse, model 10031 VITROLIFE SWEDEN AB k022295 09/12/2002
radionics pole needles RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP k021942 09/11/2002
cell robotics ultra-light peel laser system CELL ROBOTICS, INC. k021946 09/11/2002
wiener lab. ca-color arsenazo iii aa, model 4x50 ml cat.nr. 1152004, wiener lab.ca-color arsenazo iii aa, model 8 x 20 5 WIENER LABORATORIES S.A.I.C. k021334 09/10/2002
axya medical, inc, model 100 sonic scalpel ultrasonic surgical system AXYA MEDICAL, INC. k021929 09/10/2002
cranial symmetry system BEVERLY HILLS PROSTHETICS ORTHOTICS, INC. k022273 09/09/2002
normed titanium rondo fix fusion plates and screw system OSTEOMEDICS, INC. k022323 09/09/2002
normed titanium osteotomy plating system OSTEOMEDICS, INC. k022325 09/09/2002
synthes (usa) resorbable fixation system SYNTHES (USA) k021928 09/06/2002

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