FDA 510(k) Applications Submitted by Shoshana (Shosh) Friedman

FDA 510(k) Number Submission Date Device Name Applicant
K130171 01/24/2013 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD.
K980373 01/30/1998 ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE ULTRAMIND INTERNATIONAL LTD.
K020341 02/01/2002 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K070475 02/20/2007 MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD.
K010704 03/09/2001 DORNIR LC-1 CPAP SYSTEM PRYM MEDICAL LTD.
K100753 03/17/2010 FLIGHT 60 VENTILATOR, MODEL F-60 FLIGHT MEDICAL LTD.
K000888 03/20/2000 SANSIBAR CPAP SYSTEM PRYM MEDICAL LTD.
K060805 03/24/2006 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K000990 03/28/2000 OPUS 10 DENTAL DIODE LASER OPUSDENT LTD.
K031033 04/01/2003 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K131094 04/18/2013 VIMOVE DORSA VI PTY. LTD
K071153 04/25/2007 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE GIVEN IMAGING LTD.
K981668 05/11/1998 SMARTVENT 201 PORTABLE VENTILATOR VERSAMED LTD.
K981841 05/26/1998 BREATHE EASY, MODELS AD AND CD RESPIRAID LTD.
K011769 06/07/2001 OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND OPUSDENT LTD.
DEN010002 06/11/2001 GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD.
K011827 06/12/2001 ORTELIUS 800 ORTHOSCAN LTD.
K111683 06/15/2011 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD.
K012103 07/05/2001 BANDVIEW SYSTEM APPLIED SPECTRAL IMAGING, LTD.
K092144 07/15/2009 BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR ENDOCHOICE, INC.
K982470 07/16/1998 ECG ELECTRODES APRON TAPUZ MEDICAL TECHNOLOGY LTD.
K992386 07/16/1999 ALLON 2000 MTRE ADVANCED TECHNOLOGY LTD.
K012217 07/16/2001 M5T INSTANT FEVER THERMOMETER MEDISIM LTD.
K022362 07/22/2002 GIVEN DIAGNOSTICS SYSTEM GIVEN IMAGING LTD.
K002287 07/27/2000 WIZAIR COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
K032405 08/04/2003 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K052184 08/11/2005 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K112387 08/18/2011 PROCEDURE REHEARSAL STUDIO(TM) SIMBIONIX LTD.
K002712 08/31/2000 THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F S.A.A.T., LTD.
K012947 09/04/2001 SMARTFLOW FLORENCE MEDICAL LTD.
K012994 09/06/2001 WIZAIR DVT MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
K002899 09/18/2000 OPUS 20, MODEL 1ST OPUSDENT LTD.
K062786 09/18/2006 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K093003 09/28/2009 BONASTENT BILIARY ENDOCHOICE, INC.
K123223 10/15/2012 EC SINGLE USE, POLYPECTOMY SNARE ENDOCHOICE, INC.
K093269 10/19/2009 PROCEDURE REHEARSAL STUDIO SIMBIONIX LTD.
K123269 10/19/2012 PROCEDURE REHEARSAL STUDIO SIMBIONIX LTD.
K993758 11/05/1999 PROAIR 3000 COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
K984101 11/17/1998 FLEXIBLADE ARCO MEDIC LTD.
K994057 11/30/1999 SLENDAIR 4000 COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
K103695 12/17/2010 PREPEX SYSTEM CIRC MEDTECH
K053639 12/30/2005 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K022980 09/09/2002 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD.
K203192 10/28/2020 NaviCam Xpress Stomach System AnX Robotica Corp


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