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FDA 510(k) Applications Submitted by Dorit Winitz
FDA 510(k) Number
Submission Date
Device Name
Applicant
K060146
01/19/2006
ACTIVECARE ++ SYSTEM
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
K060150
01/20/2006
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
ANDANTE MEDICAL DEVICES LTD.
K070326
02/05/2007
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
WIDEMED LTD
K070375
02/08/2007
EARLYSENSE ES-16 SYSTEM
EARLYSENSE LTD.
K040591
03/08/2004
DUET SYSTEM
BIOVIEW LTD.
K080836
03/25/2008
MODIFICATION TO ENDOFAST RELIANT SYSTEM
ENDOGUN MEDICAL SYSTEMS
K050840
04/01/2005
MODIFICATION TO DUET SYSTEM
BIOVIEW LTD.
K050856
04/05/2005
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
OPHTHOCARE LTD.
K021508
05/09/2002
OPUSDUO EC DENTAL LASER SYSTEM
OPUSDENT LTD.
K061602
06/08/2006
DUET SYSTEM
BIOVIEW LTD.
K231844
06/22/2023
ProMISÖ Fixation System
Premia Spine Ltd.
K022415
07/24/2002
BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST
WAISMED LTD.
K032519
08/15/2003
ENDO PAT 2000
ITAMAR MEDICAL
K041805
07/06/2004
MICROSCOPE SYSTEM
MIRAS MIRROR IMAGING SOLUTIONS, LTD.
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