FDA 510(k) Applications for Medical Device Product Code "IZD"
(Probe, Uptake, Nuclear)

FDA 510(k) Number Applicant Device Name Decision Date
K982442 CARE WISE MEDICAL PRODUCTS CORP. C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) 08/25/1998
K962319 NEOPROBE CORP. NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES 09/13/1996
K971167 NEOPROBE CORP. NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES 06/26/1997
K961321 RADIATION MONITORING DEVICES, INC. GAMMA GUIDANCE SYSTEM 02/10/1997
K983768 RADIATION MONITORING DEVICES, INC. MODIFICATION TO GAMMA GUIDANCE SYSTEM 07/02/1999
K013751 SILICON INSTRUMENTS GMHB HANDHELD GAMMA FINDER (HGF) 02/06/2002
K101887 SURGICEYE GMBH CONFIDENT SURGERY SUITE 300, MODEL CSS300 03/22/2011
K133781 SURGICEYE GMBH DECLIPSESPECT LAPAROSCOPY 04/11/2014
K123917 SURGICEYE GMBH DECLIPSESPECT VIEWER 01/25/2013


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