FDA 510(k) Applications Submitted by AHAVA M STEIN

FDA 510(k) Number Submission Date Device Name Applicant
K140020 01/03/2014 HYPERQ ACS-100 SYSTEM BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD.
K960198 01/16/1996 DIGISCOPE RX-2 MEDIREX, INC.
K140167 01/23/2014 RENAISSANCE X SYSTEM MAZOR ROBOTICS LTD
K210201 01/25/2021 Deep Transcranial Magnetic Stimulation (DTMS) System Brainsway Ltd.
K040178 01/26/2004 PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE S.P.O. MEDICAL EQUIPMENT, LTD.
K150175 01/26/2015 HeatLux Pro I HOME SKINOVATIONS LTD.
K030357 02/03/2003 QUANTIX/OR DEVICE CARDIOSONIX, LTD.
K100415 02/16/2010 ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM LUMENIS
K100384 02/16/2010 FIBERLASE C02 LASER WAVEGUIDE LUMENIS, LTD.
K000655 02/28/2000 PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE AHAVA STEIN
K120701 03/07/2012 M2 WRIST MRI SYSTEM ASPECT IMAGING LTD
K080672 03/10/2008 BIRTHTRACK BARNEV, LTD.
K100677 03/10/2010 LYMPHA PRESS 201MAX, MODEL 201MAX MEGO AFEK AC LTD
K120812 03/16/2012 RENAISSANCE MAZOR ROBOTICS LTD
K080787 03/20/2008 BIOMOVE 5000 SYSTEM CURATRONIC, LTD.
K220819 03/21/2022 BrainsWay Deep TMS System BrainsWay Ltd.
K010888 03/23/2001 SIDEPORT PINCH CLAMP DEVICE MEDIVICE SYSTEMS, LTD.
K110911 03/31/2011 RENAISSANCE SYSTEM MAZOR ROBOTICS LTD
K060923 04/04/2006 NAVIAID BGE DEVICE, MODEL 21-001 SMART MEDICAL SYSTEMS, LTD.
K200957 04/09/2020 Brainsway Deep TMS System Brainsway Ltd.
K001162 04/10/2000 GOLDFINGER DEVICE MALI-TECH LTD.
K140926 04/11/2014 INMODE WMFACE DEVICE INMODE MD LTD.
K071178 04/27/2007 OTOMEDICS SOFT TYMPANOSTOMY TUBE OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD.
K041180 05/06/2004 QUANTIX OR VESSEL STABILIZER DEVICE CARDIOSONIX, LTD.
K131362 05/13/2013 INMODE WMBODY DEVICE INMODE MD LTD.
K151273 05/13/2015 InMode FRF Applicator Inmode MD Ltd.
K141242 05/14/2014 GLIDE DEVICE HOME SKINOVATIONS LTD.
K981853 05/26/1998 BONE INJECTION GUN (B.I.G.) DEVICE WAISMED LTD.
K091564 05/28/2009 NBM-200MP PULSE OXIMETRY DEVICE ORSENSE LTD
K051422 06/01/2005 DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE MEDISIM LTD.
K081672 06/13/2008 C-INSIGHT MAZOR SURGICAL TECHNOLOGIES LTD.
K992071 06/18/1999 TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE RON-TECH MEDICAL LTD.
K001852 06/19/2000 PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE ITAMAR MEDICAL (C.M.) 1997 LTD.
K111720 06/20/2011 AVIAFIT FLOWMEDIC LTD.
K051676 06/23/2005 SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES MAZOR SURGICAL TECHNOLOGIES LTD.
K131870 06/24/2013 GLIDE DEVICE HOME SKINOVATIONS LTD.
K972383 06/26/1997 EASY-JET DEVICE A. STEIN - REGULATORY AFFAIRS CONSULTING
K071744 06/27/2007 AVIAFIT PULSATING LEGBAND FLOWMEDIC LTD.
K151793 07/01/2015 InMode RF System INMODE MD LTD.
K012141 07/10/2001 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE EXTERNAL COUNTERPULSATION LAB
K982566 07/23/1998 AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) BAR - ADVANCED CONTROL SYSTEMS LTD.
K152087 07/27/2015 HeatLux Pro II HOME SKINOVATIONS LTD.
K102130 07/29/2010 TENZING SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD.
K082149 07/30/2008 LYMPHA PRESS OPTIMAL, MODEL# 1201AP MEGO AFEK AC LTD
K122288 07/30/2012 BRAINSWAY DEEP TMS SYSTEM BRAINSWAY, LTD
K982754 08/06/1998 EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) A. STEIN - REGULATORY AFFAIRS CONSULTING
K062295 08/07/2006 IRI INTEGRATED RETINAL IMAGER MEDIVISION MEDICAL IMAGING, LTD.
K072334 08/20/2007 SIALO DRAIN SIALO TECHNOLOGY, LTD.
K973148 08/22/1997 MACOM A. STEIN - REGULATORY AFFAIRS CONSULTING
K062450 08/22/2006 D-SPECT CARDIAC SCANNER SYSTEM SPECTRUM DYNAMICS LTD.
K072372 08/23/2007 PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE MEGO AFEK
K062578 08/31/2006 DIGI-LITE TCD DEVICE RIMED LTD.
K072468 09/04/2007 MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM SPECTRUM DYNAMICS LTD.
K082704 09/16/2008 BIRTHTRACK (A.K.A. CLM) BARNEV, LTD.
K082735 09/18/2008 STONE GRASPING BASKET, MODEL PD-T1 2115 SIALO TECHNOLOGY, LTD.
K973590 09/22/1997 HEMORRELIEF DEVICE A. STEIN - REGULATORY AFFAIRS CONSULTING
K973592 09/22/1997 WALKCARE P200 SYSTEM A. STEIN - REGULATORY AFFAIRS CONSULTING
K023231 09/27/2002 ELFCARE DEVICE, MODELS 314A THROUGH 314G MEDISEB LTD.
K072749 09/27/2007 SIALO BALLOON DILATATION CATHETER SIALO TECHNOLOGY, LTD.
DEN170078 09/29/2017 Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System Brainways Ltd.
K162781 10/03/2016 Magma Spark Formatk Systems Ltd.
K013331 10/05/2001 LYMPHA PRESS PLUS DEVICE MEGO AFEK
K003191 10/10/2000 MIS IMPLANT SYSTEM DECIVE M.I.S. IMPLANTS TECHNOLOGIES LTD.
K142952 10/10/2014 InMode Diolaze Device INMODE MD LTD.
K023431 10/15/2002 QUANTIX/ND DEVICE CARDIOSONIX, LTD.
K033413 10/27/2003 SPINEASSIST DEVICE MAZOR SURGICAL TECHNOLOGIES LTD.
K003369 10/30/2000 LIFECARE COMPACT TENS DEVICE LIFECARE LTD.
K113228 11/01/2011 RENAISSANCE SYSTEM MAZOR ROBOTICS LTD
K063363 11/07/2006 FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE FLEXICATH LTD.
K013803 11/15/2001 FLOWGUARD DEVICE BIOSONIX LTD.
K173540 11/15/2017 Brainsway Deep (DTMS) System Brainsway Ltd.
K993995 11/24/1999 VEIN ENTRY INDICATOR DEVICE (VEID) VASCULAR TECHNOLOGIES LTD.
K123682 11/30/2012 INMODE HAIR REMOVAL (HR) DEVICE INMODE MD LTD.
K063607 12/04/2006 SPINEASSIST SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD.
K143476 12/05/2014 Digi-One RIMED LTD.
K994130 12/07/1999 RECTOSIGHT RS 300-04 SIGHTLINE TECHNOLOGIES LTD.
K974588 12/09/1997 INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD RIMED LTD.
K073467 12/10/2007 SPINEASSIST SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD.
K203616 12/10/2020 Brainsway Deep (DTMS) System Brainsway Ltd.
K123860 12/14/2012 INMODE SR IPL DEVICE INMODE MD LTD.
K153566 12/14/2015 Magma System FORMATK SYSTEMS LTD.
K153568 12/14/2015 InMode Plus System InMode MD Ltd.
K203735 12/21/2020 Brainsway Deep TMS System Brainsway Ltd.
K093785 12/09/2009 MODULAR ENDOSCOPE SIALO TECHNOLOGY, LTD.
K060220 01/30/2006 PBS MODEL 701A COMPRESSION THERAPY DEVICE MEGO AFEK


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