FDA 510(k) Applications Submitted by Kevin Walls

FDA 510(k) Number Submission Date Device Name Applicant
K120032 01/04/2012 MECHANICAL WHEELCHAIR AIKIN HEALTHCARE CO., LTD
DEN090008 01/05/2009 ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL
K020094 01/11/2002 EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS REGULATORY INSIGHT, INC.
K020100 01/11/2002 SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS REGULATORY INSIGHT, INC.
K080102 01/14/2008 TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM ESCADA INTERNATIONAL, INC.
K080115 01/16/2008 I-MINI DENTAL IMPLANT OCO BIOMEDICAL
K030195 01/21/2003 BBP BONE SUBSTITUTES OCT, USA, INC.
K120257 01/27/2012 MLS, ZERONA-AD ERCHONIA MEDICAL, INC.
K110261 01/28/2011 ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS SOFLEX LIMITED
K030302 01/29/2003 HBS HEADLESS BONE SCREW SCHOENING & ASSOC., INC.
K070312 02/01/2007 EARCHECK ACOUSTIC REFLECTOMETER INNOVIA MEDICAL, LLC
K080382 02/13/2008 SELLAS DINONA CO., LTD.
K060392 02/15/2006 ASP TITANIUM SEDATELEC
K100509 02/22/2010 THL1 LASER ERCHONIA CORPORATION
K010546 02/23/2001 POWDER FREE LATEX EXAMINATION GLOVES JB STAR SDN BHD
K080513 02/25/2008 QLASER SYSTEM 2035, INC.
K020642 02/27/2002 SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR SOFLEX CONTACT LENS INDUSTRIES LTD.
K050672 03/15/2005 ERCHONIA EVRL LASER ERCHONIA MEDICAL, INC.
K030842 03/17/2003 ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP SOFLEX CONTACT LENS INDUSTRIES LTD.
K130741 03/19/2013 ERCHONIA PL5000 ERCHONIA MEDICAL INC
K020917 03/21/2002 SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR ST. SHINE OPTICAL CO., LTD.
K130856 03/28/2013 BIA / VITALITY ANALYZER IPGDX, LLC
K140780 03/28/2014 KEGEL SMART, KEGELSMART PEARL REGULATORY INSIGHT, INC.
K110926 04/01/2011 BONE PLATE; BONE SCREW BIOMATERIALS KOREA INC.
K130922 04/03/2013 ERCHONIA VERJU LASER SYSTEM WITH MASSAGER ERCHONIA MEDICAL, INC.
K110960 04/05/2011 ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE KOON SENG SDN.BHD
K031130 04/09/2003 YA MEI FIRST AID KIT YA MEI TECHNOLOGY CO., LTD.
K130996 04/10/2013 ERCHONIA EMERGE ERCHONIA MEDICAL, INC.
K091158 04/21/2009 SCALAR WAVE LASER SYSTEM STELLAR LASERS
K141042 04/23/2014 MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES MERCATOR MEDICAL (THAILAND) LTD.
K011256 04/24/2001 TORIC LITE LENS SOFLEX CONTACT LENS INDUSTRIES LTD.
K021295 04/24/2002 SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR ST. SHINE OPTICAL CO., LTD.
K131207 04/29/2013 FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER SURGICAL INSTRUMENT ENGINEERING AG
K041139 04/30/2004 ERCHONIA EML LASER ERCHONIA MEDICAL, INC.
K101267 05/05/2010 PREMIO 10 MOXA SEDATELEC
K021442 05/06/2002 OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR OEMEDIC INTERNATIONAL, INC.
K021446 05/06/2002 OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR OEMEDIC INTERNATIONAL, INC.
K101430 05/21/2010 MLS-AC DERMA SCANNER ERCHONIA CORPORATION
K021720 05/24/2002 MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR SOFLEX ISRALENS CONTACT LENS LTD.
K071445 05/24/2007 TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS ESCADA INTERNATIONAL, INC.
K051414 05/31/2005 EYE CUP, STERILE 1 AND NON STERILE TOLLOT PTY.LTD.(AAXIS PACIFIC)
K031716 06/03/2003 SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE ASIA-MED GMBH AND CO KG
K121690 06/07/2012 ETCHONIA ZERONA ARMS ERCHONIA CORPORATION
K121695 06/07/2012 ERCHONIA ZERONA ERCHONIA CORPORATION
K011808 06/11/2001 ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) ASIA-MED GMBH AND CO KG
K051565 06/14/2005 PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA PROTON HEALTHCARE LTD.
K051566 06/14/2005 PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER PROTON HEALTHCARE LTD.
K041605 06/15/2004 PRECISION RXI ANALOG X-RAY SYSTEM GENERAL MEDICAL MERATE S.P.A.
K001835 06/16/2000 IRV2000 INDIVIDUAL RECREATIONAL VEHICLE TRAC ABOUT, INC.
K091770 06/16/2009 VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD.
K091772 06/16/2009 POWDER-FREE VINYL EXAM GLOVES SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD.
K021977 06/17/2002 HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR CONTAMAC LTD.
K131797 06/18/2013 3B LASER NEEDLE LIVETEC GMBH
K081762 06/20/2008 CURBELL PATIENT MONITORING CABLES CURBELL ELECTRONICS INC.
K111809 06/27/2011 SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS BIOMATERIALS KOREA INC.
K071775 06/29/2007 DASH EZSURGICAL
K022194 07/05/2002 TRAXX ELECTRIC WHEELCHAIR CROSSROADS DISTRIBUTION COMPANY, L.L.C.
K022299 07/16/2002 TRILUX, Z-TONE, ACRY ROCK RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO
K022300 07/16/2002 ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V DENTAL VIPI LTDA
K051940 07/18/2005 CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA SIS LTD. SURGICAL INSTRUMENT SYSTEMS
K032216 07/21/2003 BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM BIOPTRON AG
K122213 07/25/2012 ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR SOFLEX LIMITED
K122220 07/25/2012 ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S SOFLEX LIMITED
K112154 07/27/2011 FEMTO LDV SIE AG,SURGICAL INSTUMENT ENGINEERING
K142042 07/28/2014 ERCHONIA SHL ERCHONIA CORPORATION
K122315 08/01/2012 FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC OCULUS PRIVATE LIMITED
K042063 08/02/2004 PRESS TACK NEEDLE ASIA-MED GMBH & CO. KG. - WERK SUHL
K052085 08/02/2005 STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES ASIA-MED GMBH AND CO KG
K032392 08/04/2003 MORALES PROTRACTION FACEMASK ORTOSIM, S.A. DE C.V.
K092326 08/04/2009 SMOOTHCOOL JEISYS MEDICAL, INC.
K082243 08/07/2008 PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS GENERAL MEDICAL MERATE S.P.A.
K072206 08/08/2007 ERCHONIA EML LASER ERCHONIA MEDICAL, INC.
K082291 08/11/2008 A-LAP SET (A-LAP, EZAXESS, TROCAR) EZSURGICAL
K172439 08/11/2017 Siberian Fit Vydence
K002510 08/15/2000 SMARTLENS ODC OPHTHALMIC DEVELOPMENT CO. AG
K102341 08/18/2010 VIPI BLOCK VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE
K092542 08/19/2009 M MEDISCITEC INC.
K082436 08/25/2008 EXTT-101 APIMEDS, INC
K102483 08/30/2010 SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 SUNSET HEALTHCARE SOLUTIONS, LLC
K112505 08/30/2011 ETHEREA REGULATORY INSIGHT, INC.
K072447 08/31/2007 PENTABORN MEDISCITEC INC.
K082609 09/08/2008 ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL
DEN100024 09/09/2010 ZAP-IT! ECOBRANDS LTD.
K052531 09/15/2005 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER FU HONG INDUSTRIES LTD.
K092858 09/16/2009 SAFERSONIC SONOGRAPHY COVER SAFERSONIC MEDIZINPRODUKTE GMBH
K132896 09/16/2013 CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE ASIA-MED GMBH AND CO KG
K132940 09/19/2013 ERCHONIA ALLAY ERCHONIA MEDICAL, INC.
K052586 09/20/2005 A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P TAIWAN AN I CO.,LTD.
K092910 09/22/2009 FLUID-FILLED TEETHER QUALIMAN INDUSTRIAL CO., LTD
K032967 09/23/2003 PASCAL DYNAMIC CONTOUR TONOMETER SMT SWISS MICROTECHNOLOGY AG
K123034 09/28/2012 VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED UNILENE S.A.C.
K062979 09/29/2006 THYROSAMPLER ACD MEDICAL INNOVATION CORP.
K082871 09/29/2008 XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM SIS LTD. SURGICAL INSTRUMENT SYSTEMS
K082911 09/30/2008 SMOOTHCOOL HR SYSTEM JEISYS MEDICAL, INC.
K072823 10/02/2007 MERILAS 532A MERIDIAN AG
K072833 10/03/2007 P-NAIN SYSTEM JEISYS MEDICAL, INC.
K052845 10/07/2005 B-CARE POWDERED LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD.
K052846 10/07/2005 TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE MAANSHAN MEDICAL INSTRUMENTS CO., LTD.
K123237 10/16/2012 ZERONA 2.0 LASER ERCHONIA CORPORATION
K003236 10/17/2000 RETINADX REGULATORY ASSOCIATES, INC.
K013467 10/18/2001 TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR SOFLEX CONTACT LENS INDUSTRIES LTD.
K013469 10/18/2001 EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR SOFLEX CONTACT LENS INDUSTRIES LTD.
K113123 10/21/2011 OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM THE ORTHOPAEDIC IMPLANT COMPANY
K103132 10/25/2010 FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI OCULUS PRIVATE LIMITED
K043150 11/15/2004 AMADEUS II EPIKERATOME SIS LTD. SURGICAL INSTRUMENT SYSTEMS
K113390 11/16/2011 LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) MERIDIAN AG
K013824 11/19/2001 ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH DENTAL MANUFACTURING S.P.A
K033655 11/21/2003 SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR SOFLEX CONTACT LENS INDUSTRIES LTD.
K083512 11/26/2008 FLUID-FILLED TEETHER WILTEC INDUSTRIES LTD.
K113544 12/01/2011 ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER PROSPERA CORPORATION
K133718 12/04/2013 ZERONA ERCHONIA CORPORATION
K053511 12/16/2005 DA VINCI FEMTOSECOND SURGICAL LASER SIE LTD SURGICAL INSTRUMENT ENGINEERING
K083901 12/29/2008 NAVI ROOT S-DENTI CO., LTD.
K094047 12/31/2009 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR MODERN REHABILITATION SOLUTIONS CO., LTD
K100098 01/13/2010 PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE JM SYSTEM CO., LTD.
K100780 03/19/2010 VITAL SUTURES, SUTUREX, CIRUGIA PERUANA UNILENE S.A.C.
K102110 07/28/2010 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN FOSHAN SHUNDE JAEYONG HARDWARE CO., LTD.
K093370 10/29/2009 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER FU HONG INDUSTRIES LTD.
K063495 11/20/2006 C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS BIOMATERIALS KOREA INC.
K093751 12/07/2009 CL-DC20, CL-DC21 GOOD DOCTORS CO., LTD.
K062792 09/18/2006 ERCHONIA IOTO_240 ERCHONIA MEDICAL, INC.


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