FDA 510(k) Applications Submitted by RICHARD Y LI

FDA 510(k) Number Submission Date Device Name Applicant
K130305 02/05/2013 LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE LINA MEDICAL APS
K131176 04/25/2013 ROSS RU SKIN DISCONTINUITIES BIOTD, S.A.
K141637 06/19/2014 SPB SKIN EMULSION BIOTD, S.A.
K962180 06/06/1996 CATH SEAL UNIVERSAL MEDICAL INSTRUMENT CORP.
K012425 07/30/2001 BIOMEDICS UV MULTIFOCAL OCULAR SCIENCES PUERTO RICO, INC.
K013377 10/12/2001 BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC.
K993580 10/22/1999 SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR SPECIALTY ULTRAVISION, INC.
K180065 01/09/2018 FUSION Plus Curing Light DentLight Inc.
K101140 04/22/2010 DENTLIGHT ORAL EXAM LIGHT KIT DENTLIGHT INC.
K201387 05/27/2020 Ultrafast, Ultrafast Plus, Ultrafast Lite DentLight Inc.
K052593 09/21/2005 FUSION CURING LIGHT DENTLIGHT INC.
K021700 05/23/2002 ANIMUS EZSERTER INFUSION SET INSERTER ANIMAS CORP.
K050228 02/01/2005 AGFA HEARTLAB CARDIOVASCULAR HEARTLAB, INC.
K050858 04/05/2005 ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM HEARTLAB, INC.
K040896 04/06/2004 MODIFICATION TO ENCOMPASS HEARTLAB, INC.
K042042 07/29/2004 ULTRASOUND CAPTURE SYSTEM HEARTLAB, INC.
K954479 09/26/1995 DICOMVIEW HEARTLAB, INC.
K062021 07/17/2006 KOWA VX-10I KOWA CO. LTD.
K063759 12/19/2006 HEATMARKER TIME TEMPERATURE INDICATOR TEMPTIME CORPORATION
K980836 03/04/1998 GENIE CUP INTEGRATED SCREENING DEVICE APPLIED TECHNOLOGY VENTURES, L.L.C.
K973726 09/30/1997 FINGERPRINT DRUG SCREENING DEVICE APPLIED TECHNOLOGY VENTURES, L.L.C.
K053257 11/22/2005 PARA-PRO FC50 ALPHA-TEC SYSTEMS, INC.
K002813 09/08/2000 NIPRO SAFETOUCH SAFETY FISTULA NEEDLE NIPRO MEDICAL CORP.
K032777 09/08/2003 MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE NIPRO MEDICAL CORP.
K023007 09/09/2002 DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC.
K010264 01/29/2001 NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET NIPRO MEDICAL CORP.
K030198 01/21/2003 HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC.
K981622 05/07/1998 DADE TRU-LIQUID CARDIAC CONTROL DADE BEHRING, INC.
K001465 05/10/2000 NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET NIPRO MEDICAL CORP.
K060102 01/13/2006 SYNERGEYES PS HYBRID CONTACT LENS Synergeyes, Inc.
K020193 01/18/2002 OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS CL MCINTOSH
K080193 01/25/2008 SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR Synergeyes, Inc.
K020389 02/05/2002 BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS OCULAR SCIENCES
K050350 02/11/2005 THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) NOTAL VISION, INC.
K050623 03/10/2005 VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D VOLK OPTICAL, INC.
K081034 04/11/2008 SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS Synergeyes, Inc.
K051035 04/22/2005 SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS SYNERGEYES
K031477 05/09/2003 HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES, INC.
K021699 05/22/2002 AUTOLENS CLEANING AND DISINFECTING UNIT AUTOLENS INC.
K991965 06/10/1999 PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES PURILENS, INC.
K071755 06/28/2007 FALCK APPLANATION TONOMETER (FAT2) FALCK MEDICAL INC.
K992264 07/06/1999 OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC.
K032309 07/25/2003 NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY NOVELENS, INC.
K012530 08/06/2001 AA-1 SYSTEM NEUROVISION, INC.
K982947 08/21/1998 BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC.
K012852 08/24/2001 EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS OPTONOL, LTD
K023221 09/27/2002 CONTACT LASER & DIAGNOSTIC LENSES VOLK OPTICAL, INC.
K052675 09/27/2005 SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS SYNERGEYES
K003136 10/06/2000 OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC.
K964289 10/28/1996 EYE FIXATION SPECULUM EYEFIX, INC.
K984046 11/12/1998 BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS OCULAR SCIENCES PUERTO RICO, INC.
K113586 12/05/2011 SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS Synergeyes, Inc.
K014044 12/07/2001 MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) NOTAL VISION, INC.
K083921 12/31/2008 SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS Synergeyes, Inc.
K061120 04/21/2006 SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES Synergeyes, Inc.
K970170 01/09/1997 SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE RICHARD G. LINDSAY
K963287 08/21/1996 VACUUM CUP (004SD) SWIFT DELIVERY PRODUCTS
K973942 09/26/1997 SWIFT DELIVERY PRODUCT #300 SWIFT DELIVERY PRODUCTS
K013460 10/18/2001 SWIFT LOW PROFILE CUP (PRO CUP) SWIFT DELIVERY PRODUCTS
K032076 07/07/2003 SENOVA(R) BLOOD GLUCOSE MONITOR CHDIAGNOSTICS LLC
K043213 11/19/2004 KOWA VX-10 KOWA CO. LTD.
K971929 05/27/1997 AMSINO URINARY LEG BAG AMSINO INTL., INC.
K992719 08/12/1999 AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE AMSINO INTL., INC.
K973107 08/19/1997 AMSINO I.V. ADMINISTRATION SET AMSINO INTL., INC.
K973199 08/26/1997 AMSINO SUCTION CATHETER AMSINO INTL., INC.
K974042 10/24/1997 AMSURE CLEANSING ENEMA SET AMSINO INTL., INC.
K960185 01/16/1996 AMSINO CLINICAL THERMOMETER AMSIA INTL., INC.
K964745 11/26/1996 AMSINO URINARY DRAINAGE BAG AMSINO INTL., INC.


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