FDA 510(k) Applications Submitted by Tony Tony

FDA 510(k) Number Submission Date Device Name Applicant
K082284 08/11/2008 AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM ALVEOLUS, INC
K083625 12/08/2008 AERO DV TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC
K983527 10/08/1998 MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE DOFI TECHNOLOGIES, INC.
K173018 09/28/2017 MDR17 Mobile Direct Radiographic System Del Medical, Inc.
K021359 01/30/2002 DIGI-PRO TENS MODEL WL-2203 AND WL-2205 WELL-LIFE HEALTHCARE, INC.
K072516 09/07/2007 MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR MIDMARK DIAGNOSTICS GROUP
K200423 02/20/2020 Electric Wheelchair (XW-LY001) Yongkang Dingchang Industry & Trade Co., LTD.
K010075 01/09/2001 TEKNIQUE HOVEROUND CORP.
K090108 01/15/2009 HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR HOVEROUND CORP.
K100527 02/24/2010 HOVEROUND TEKNIQUE, MODEL HD-6 HOVEROUND CORP.
K021136 04/09/2002 TEKNIQUE-HOVEROUND POWER WHEEL CHAIR HOVEROUND CORP.
K042033 07/29/2004 HOVEROUND POWER WHEELCHAIR, MODEL HD700 HOVEROUND CORP.
K022993 09/09/2002 HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS HOVEROUND CORP.
K042545 09/20/2004 HOVEROUND MPV-5 POWERCHAIR HOVEROUND CORP.
K042920 10/22/2004 HOVEROUND SE-3 POWERCHAIR HOVEROUND CORP.
K043069 11/08/2004 HOVEROUND E100 POWER CHAIR HOVEROUND CORP.
K093946 12/23/2009 HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 HOVEROUND CORP.
K963211 08/16/1996 UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) AMERICAN HEALTHCARE PRODUCTS, INC.
K213576 11/10/2021 Tatum Surgical Dental Implant System Suncoast Dental, Inc. dba Tatum Surgical
K974516 12/02/1997 ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE ENDOLAP, INC.
K974515 12/02/1997 ENDOLAP RESECTOSCOPE ROLLER ELECTRODE ENDOLAP, INC.
K100350 02/12/2010 HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT HOVEROUND CORP.
K120028 01/04/2012 AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES Pegavision Corporation
K140025 01/06/2014 AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES Pegavision Corporation
K132587 08/16/2013 MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR NED DISPLAY SOLUTIONS LTD.
K133708 12/04/2013 MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR NEC DISPLAY SOLUTIONS, LTD.
K123973 12/26/2012 AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES Pegavision Corporation
K003123 10/05/2000 RENAX A.V. FISTULA NEEDLE SETS SUNDER BIOMEDICAL TECH. CO., LTD.
K024007 12/04/2002 SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J SUNDER BIOMEDICAL TECH. CO., LTD.
K014140 12/17/2001 RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET SUNDER BIOMEDICAL TECH. CO., LTD.
K992177 06/28/1999 NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE PT. BERLIAN GLOVINDO
K240749 03/19/2024 PILLAR SA Ti Spacer System (82-XXX) Orthofix, Inc.
K241117 04/23/2024 M6-CÖ Single Use, Disposable Instrumentation Spinal Kinetics / Orthofix / SeaSpine
K151177 05/01/2015 XenMatrix AB Surgical Graft C.R. Bard
K162193 08/04/2016 XenMatrix AB Surgical Graft C.R. Bard
K173143 09/29/2017 Phasix ST Mesh C. R. Bard Inc
K133223 10/21/2013 XENMATRIX AB SURGICAL GRAFT C.R. BARD, INC.
K143380 11/25/2014 Phasix ST Mesh C. R. Bard Inc
K993088 09/16/1999 PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI PURITAN BENNETT CORP.
K993220 09/27/1999 PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM PURITAN BENNETT CORP.
K051516 06/08/2005 TRABECULAR METAL REVISION SHELL LINERS ZIMMER, INC.
K161039 04/13/2016 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) NeoMed, Inc.
K152857 09/30/2015 NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps NEOMED, INC.
K143344 11/21/2014 NeoMed NeoConnect Enteral Syringes with ENFit Connector NEOMED, INC.
K183540 12/20/2018 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) NeoMed, Inc.
K982542 07/21/1998 STRYKER URETERAL ILLUMINATOR SYSTEM III Stryker Endoscopy
K223922 12/30/2022 SOMNUM (V.1.1.2.) Honeynaps Co., Ltd
K180230 01/26/2018 NEST Interbody System Paonan Biotech Co., Ltd.
K963597 09/09/1996 SILENT NIGHT I LOCAL SILENCE, INC.
K990522 02/18/1999 WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS LA MONT MEDICAL, INC.
K202648 09/11/2020 Biofeedback Nerve and Muscle Stimulator Shenzhen Konmed Technology Co., Ltd.
K200550 03/03/2020 Vitalograph Model 2120 In2itive eDiary Vitalograph Ireland Ltd.
K221030 04/07/2022 Model 9100 PFT/DICO Vitalograph Ireland Ltd.
K201562 06/10/2020 Spirotrac Vitalograph Ireland Ltd.
K212938 09/15/2021 Vitalograph Model 6000 Alpha Vitalograph Ireland Ltd.
K223818 12/21/2022 Model 9160 VitaloQUB Vitalograph Ireland Ltd.
K032064 07/03/2003 THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM THEKEN SURGICAL,LLC
K182440 09/07/2018 Body System A-1 Engineering
K140487 02/27/2014 VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING STERIS Corporation
K140494 02/27/2014 V-PRO STERILIZATION TRAY/ STERILIZATION MAT STERIS Corporation
K180689 03/15/2018 Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device STERIS Corporation
K181686 06/26/2018 CELERITY 20 Steam Biological Indicator STERIS Corporation
K192722 09/27/2019 Padlock Clip defect closure system, Padlock Pro-Select defect closure device STERIS Corporation
K061866 07/03/2006 NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS THERMOTEK, INC.
K243080 09/30/2024 Riptide Aspiration System Micro Therapeutics Inc. d/b/a ev3 Neurovascular
K243418 11/04/2024 RiptideÖ Aspiration Pump; RiptideÖ Collection Canister with Intermediate Tubing Micro Therapeutics Inc. d/b/a ev3 Neurovascular
K962953 07/30/1996 DEODORANT PANTY SHIELD PARAGON TRADE BRANDS, INC.
K962954 07/30/1996 DEODORANT MAXI PAD PARAGON TRADE BRANDS, INC.
K040709 03/18/2004 PROTOS SOFTWARE AKTINA MEDICAL PHYSICS CORP.
K151097 04/24/2015 Active Breathing Coordinator AKTINA MEDICAL CORPORATION
K131313 05/07/2013 ACTIVE BREATHING COORDINATOR AKTINA MEDICAL CORP.
K081935 07/07/2008 STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 AKTINA MEDICAL PHYSICS CORP.
K161984 07/19/2016 Interlocked Circular Small Field Collimators, Elekta Integrated AKTINA MEDICAL CORPORATION
K032248 07/22/2003 PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 AKTINA MEDICAL PHYSICS CORP.
K192102 08/05/2019 Thermoplastic Masks Aktina Medical Corporation
K103616 12/10/2010 PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER AKTINA MEDICAL PHYSICS CORP.
K240112 01/16/2024 Light Cure Composite Sincera Technology (Changchun) Co., Ltd.
K241056 04/18/2024 Light Cure Adhesive Sincera Technology (Changchun) Co., Ltd.
K171721 06/12/2017 Electrodes with silver conductive Shenzhen Konmed Technology Co., Ltd
K171722 06/12/2017 Electrodes with snap / Electrodes with pigtail Shenzhen Konmed Technology Co., Ltd
K163288 11/22/2016 Pelvifine Pelvic Muscle Trainer Shenzhen Konmed Technology Co., Ltd.
K024105 12/13/2002 VELOPEX AQUACUT FLUID ABRASION UNIT VELOPEX INTERNATIONAL, INC.
K092204 07/22/2009 PMD VIEWER SPENCER TECHNOLOGIES
K002533 08/16/2000 TCD 100M, PWD13 TRANSDUCER SPENCER TECHNOLOGIES
K181426 05/31/2018 Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) Jiangsu Micsafe Medical Technology Co., Ltd
K212019 06/28/2021 Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Colle Jiangsu Micsafe Medical Technology Co., Ltd
K202205 08/05/2020 Surgical Face Mask Jiangsu Micsafe Medical Technology Co., Ltd
K202570 09/04/2020 Insulin Syringe, Insulin Syringe with Safety Retractable Jiangsu Micsafe Medical Technology Co., Ltd
K183665 12/27/2018 Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use Jiangsu Micsafe Medical Technology Co., Ltd.
K113148 10/24/2011 E-PASS SYNEXMED(SHENZHEN)COMPANY LIMITED
K020020 01/03/2002 THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) WELL-LIFE HEALTHCARE, INC.
K102508 09/01/2010 YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 YU LONG SHENG TECHNOLOGY CO., LTD
K042631 09/27/2004 EAR THERMOMETER, MODEL WL-320X INNOVATECH, INC
K053411 12/07/2005 DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS MICROGENICS CORP.
K010383 02/08/2001 TEMP SCAN TENGHI CO. LTD
K030537 02/20/2003 DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B WELL-LIFE HEALTHCARE, INC.
K020314 01/30/2002 DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 WELL-LIFE HEALTHCARE, INC.
K032308 07/25/2003 BLOOD PRESSURE MONITOR, MODEL M100 MEDITEK TECHNOLOGY, INC.
K062675 09/08/2006 GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES GEMORE TECHNOLOGY CO., LTD.
K023500 10/18/2002 DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 INNOVATECH, INC
K024100 12/12/2002 IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND THERATECH, INC.
K080838 03/25/2008 ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM ALVEOLUS, INC.
K072720 09/25/2007 ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ALVEOLUS, INC.
K974356 11/19/1997 SURGEON'S GLOVES AMERICAN HEALTH PRODUCTS, INC.
K962962 07/30/1996 DEODORANT PANTY LINER PARAGON TRADE BRANDS, INC.
K013261 10/01/2001 MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE SHANGHAI MOTEX HEALTHCARE CO., LTD.
K030207 01/21/2003 NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 SHANGHAI MOTEX HEALTHCARE CO., LTD.
K020837 03/14/2002 MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE SHANGHAI MOTEX HEALTHCARE CO., LTD.
K970916 03/12/1997 H.V. PULSE LAVAGE (L31 SERIES) GLOBAL MEDICAL PRODUCTS, INC.
K030065 01/07/2003 WAKO NEFA LINEARITY SET WAKO CHEMICALS, USA, INC.
K010334 02/02/2001 WAKO LIPID CALIBRATOR WAKO CHEMICALS, USA, INC.
K010332 02/02/2001 WAKO IMMUNOASSAY CALIBRATOR SET WAKO CHEMICALS, USA, INC.
K010326 02/02/2001 WAKO AUTOKIT C3 WAKO CHEMICALS, USA, INC.
K010325 02/02/2001 WAKO AUTOKIT C4 WAKO CHEMICALS, USA, INC.
K960874 03/04/1996 COMPLEMENT CONTROL WAKO CHEMICALS, USA, INC.
K970986 03/18/1997 WAKO DIRECT BILIRUBIN V WAKO CHEMICALS, USA, INC.
K970985 03/18/1997 WAKO TOTAL BILIRUBIN V WAKO CHEMICALS, USA, INC.
K020972 03/26/2002 WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET WAKO CHEMICALS, USA, INC.
K001005 03/29/2000 WAKO HDL-C/LDL-C CALIBRATOR WAKO CHEMICALS, USA, INC.
K001002 03/29/2000 WAKO LIPASE CALIBRATOR WAKO CHEMICALS, USA, INC.
K001004 03/29/2000 WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR WAKO CHEMICALS, USA, INC.
DEN050002 04/07/2005 LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS WAKO CHEMICALS, USA, INC.
K981446 04/22/1998 WAKO AUTOKIT LP(A) WAKO CHEMICALS, USA, INC.
K001921 06/23/2000 WAKO AUTOKIT LP(A)/EXPRESS 550 WAKO CHEMICALS, USA, INC.
K001920 06/23/2000 WAKO AUTOKIT LP(A)/ RA,500/1000, WAKO CHEMICALS, USA, INC.
K001919 06/23/2000 WAKO AUTOKIT LP(A)/DADE DEMENSION WAKO CHEMICALS, USA, INC.
K001934 06/26/2000 WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX WAKO CHEMICALS, USA, INC.
K001933 06/26/2000 WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO WAKO CHEMICALS, USA, INC.
K001931 06/26/2000 WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET WAKO CHEMICALS, USA, INC.
K001929 06/26/2000 WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA WAKO CHEMICALS, USA, INC.
K982271 06/29/1998 WAKO DIRECT LDL-C WAKO CHEMICALS, USA, INC.
K973055 08/15/1997 WAKO CH50 LINEARITY SET WAKO CHEMICALS, USA, INC.
K973072 08/18/1997 WAKO NEFA LINEARITY SET WAKO CHEMICALS, USA, INC.
K993162 09/22/1999 WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR WAKO CHEMICALS, USA, INC.
K963847 09/25/1996 WAKO DIRECT HDL-C WAKO CHEMICALS, USA, INC.
K993219 09/27/1999 WAKO BILIRUBIN CALIBRATOR WAKO CHEMICALS, USA, INC.
K993466 10/13/1999 WAKO L-TYPE TRIGLYCERIDE TEST WAKO CHEMICALS, USA, INC.
K993468 10/13/1999 WAKO L-TYPE GOT TEST WAKO CHEMICALS, USA, INC.
K993469 10/13/1999 WAKO L-TYPE UA F TEST WAKO CHEMICALS, USA, INC.
K955156 11/13/1995 WAKO AUTOKIT CRP NEW WAKO CHEMICALS, USA, INC.
K984119 11/18/1998 WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR WAKO CHEMICALS, USA, INC.
K984122 11/18/1998 WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR WAKO CHEMICALS, USA, INC.
K993927 11/18/1999 WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD WAKO CHEMICALS, USA, INC.
K993924 11/18/1999 WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD WAKO CHEMICALS, USA, INC.
K993925 11/18/1999 WAKO L-TYPE UN TEST WAKO CHEMICALS, USA, INC.
K984184 11/23/1998 WAKO L-TYPE AMYLASE WAKO CHEMICALS, USA, INC.
K033860 12/12/2003 AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR WAKO CHEMICALS, USA, INC.
K024281 12/23/2002 WAKO L-TYPE GLUCOSE 2 WAKO CHEMICALS, USA, INC.
K024280 12/23/2002 WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET WAKO CHEMICALS, USA, INC.
K003342 10/25/2000 WAKO CRP-UL, CRP-UL CALIBRATOR SET WAKO CHEMICALS, USA, INC.
K110166 01/20/2011 CLEARCUT S SAFETY KNIFE ALCON RESEARCH, LTD.
K982657 07/30/1998 AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 MICROVENA CORP.


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