FDA 510(k) Applications Submitted by L S AY

FDA 510(k) Number Submission Date Device Name Applicant
K964997 12/16/1996 S-SCORT (2500) SSCOR
K212622 08/18/2021 Zyter RPM Zyter, Inc.
K221475 05/20/2022 MyClearALIGN Dental Aligner System Key Dental Technologies, LLC
K043425 12/13/2004 SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) SHEATHING TECHNOLOGIES, INC.
K980465 02/05/1998 OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS OLYMPUS AMERICA, INC.
K001766 06/12/2000 OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE OLYMPUS OPTICAL CO., LTD.
K982734 08/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE THE OLYMPUS OPTICAL CO.
K982733 08/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE THE OLYMPUS OPTICAL CO.
K982725 08/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE OLYMPUS AMERICA, INC.
K990175 01/19/1999 SHEATHES (NON-LATEX), STERILE SHEATHING TECHNOLOGIES, INC.
K963831 09/24/1996 SHEATHES (NON-LATEX) MEDICAL RESOURCES
K022269 07/15/2002 COATED VICRYL* (POLYGLACTIN 910) SUTURE ETHICON, INC.
K080069 01/10/2008 DIMERTEST AMERICAN DIAGNOSTICA, INC.
K161052 04/14/2016 OsteoFab Patient Specific Facial Device OXFORD PERFORMANCE MATERIALS, INC.
K121818 06/20/2012 OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE OXFORD PERFORMANCE MATERIALS
K142005 07/23/2014 SpineFab Vertebral Body Replacement (VBR) System OXFORD PERFORMANCE MATERIALS
K052124 08/05/2005 ACTICLOT, MODEL 824 AMERICAN DIAGNOSTICA, INC.
K133809 12/16/2013 OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE OXFORD PERFORMANCE MATERIALS
K051137 05/04/2005 TECHDEVICE OCCLUSION BALLOON CATHETER TECHDEVICE CORPORATION
K053028 10/27/2005 TECHDEVICE GUIDEWIRE TECHDEVICE CORPORATION
K053251 11/21/2005 TECHDEVICE GUIDEWIRE TECHDEVICE CORPORATION
K033457 10/30/2003 M2 COMPATIBLE MICROKERATOME BLADE MICRO SPECIALTIES, INC.
K210235 01/28/2021 Verrata PLUS Pressure Guide Wire Volcano Corporation
K150806 03/26/2015 PulseFlowDF PulseFlow Technologies
K141159 05/05/2014 KONUS DENTAL IMPLANT SYSTEM ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH
K191258 05/10/2019 Intraosseous infusion device Einstein Works, L.L.C.
K182770 09/28/2018 Adult Intraosseous Infusion Device Einstein Works, L.L.C
K230469 02/21/2023 Compact Wearable Pump Lansinoh Laboratories
K222726 09/08/2022 Smartpump 3.0 Double Electric Breast Pump Lansinoh Laboratories
K182749 09/28/2018 Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd
K173251 10/10/2017 LumiCoil Platinum Fiducial Marker Boston Scientific Corporation
K203322 11/12/2020 SpyGlass Discover Retrieval Basket Boston Scientific Corporation
K182095 08/03/2018 Tina-quant Transferrin ver.2 (urine application) Roche Diagnostics Operations (RDO)
K140208 01/28/2014 FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII EDWARDS LIFESCIENCES, LLC.
K100569 03/01/2010 MERIT EMBOLECTOMY CATHETER MODEL ASAP100 MERIT MEDICAL SYSTEMS, INC.
K162995 10/27/2016 Ibis« Pedicle Screw System Ortho Development Corporation
K120633 03/01/2012 MAYFIELD SKULL CLAMP INTEGRA LIFESCIENCES CORPORATION
K113570 12/02/2011 INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP INTEGRA BURLINGTON MA, INC.
K060125 01/18/2006 SONIC PALPOMETER PALPOMETER SYSTEMS, INC.
K090106 01/01/2009 PRELUDE ONE DANVILLE MATERIALS, INC.
K210350 02/08/2021 Gemini 2 810+980 Soft Tissue Laser Azena Medical, LLC
K110642 03/07/2011 SILJETR SYSTEM DANVILLE MATERIALS INC.
K121880 06/28/2012 DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID DANVILLE MATERIALS, INC.
K111876 07/01/2011 Z BOND, PRELUDE ONE DANVILLE MATERIALS, INC.
K092912 09/22/2009 STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 DANVILLE MATERIALS, INC.
K102753 09/23/2010 TURBO TEMP 3 DANVILLE MATERIALS, INC.
K192617 09/23/2019 Gemini 810+980 Soft Tissue Laser Azena Medical, LLC
K063532 11/22/2006 BARD E LUMINEXX BILIARY STENT BARD PERIPHERAL VASCULAR, INC.
K231148 04/21/2023 ScleroSafeÖ 150 mm, ScleroSafeÖ 350 mm VVT Medical Ltd.
K192185 08/12/2019 The Cellfina System Ulthera, Inc
K061581 06/07/2006 EXCEL HIGH SPEED DENTAL HANDPIECE ORTHOSOURCE, INC.
K061897 07/03/2006 EXCEL CONTRA ANGLE HANDPIECE ORTHOSOURCE, INC.
K020489 02/13/2002 G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE TOSOH MEDICS, INC.
K010796 03/16/2001 AIA-PACK BRCA, ST AIA PACK BRCA TOSOH MEDICS, INC.
K991252 04/13/1999 AIA-PACK FT3 ASSAY TOSOH MEDICS, INC.
K011434 05/10/2001 G7 AUTOMATED HPLC ANALYZER TOSOH MEDICS, INC.
K102029 07/19/2010 PEAK PULSAR II GENERATOR MODEL PS100-102 PEAK SURGICAL, INC.
K012820 08/23/2001 AIA-PACK CTNI 2ND-GEN ASSAY TOSOH MEDICS, INC.
K023091 09/17/2002 ST AIA-PACK TESTOSTERONE ASSAY TOSOH MEDICS, INC.
K083415 11/18/2008 PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE PEAK SURGICAL, INC.
K023893 11/22/2002 ST AIA-PACK CEA ENZYME IMMUNOASSAY TOSOH MEDICS, INC.
K023894 11/22/2002 ST AIA-PACK AFP ENZYME IMMUNOASSAY TOSOH MEDICS, INC.
K023891 11/22/2002 ST AIA-PACK CA 125 ENZYME IMMUNOASSAY TOSOH MEDICS, INC.
K093695 11/30/2009 PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE PEAK SURGICAL, INC.
K163367 11/30/2016 GenetiSure Dx Postnatal Assay Agilent Technologies, Inc.
K103775 12/27/2010 PEAK SUCTION COAGULATOR PEAK SURGICAL, INC.
K200401 02/18/2020 Apogee Incoba Ltd. d/b/a Dynaris
K060519 02/27/2006 INTRODUCER ASSEMBLY WITH ROTATOR LOCK TELEFLEX MEDICAL
K070561 02/27/2007 KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES TELEFLEX MEDICAL
K981246 04/06/1998 BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) INTEGRA NEUROCARE LLC.
K081729 06/18/2008 MODIFICATION TO GFX NERVE ABLATION SYSTEM BIOFORM MEDICAL, INC.
K061736 06/20/2006 COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA TELEFLEX MEDICAL
K062914 09/27/2006 HEM-O-LOK LIGATION CLIP TELEFLEX MEDICAL
K043205 11/19/2004 RUSCH EASY TUBE TELEFLEX MEDICAL
K063758 12/19/2006 CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R TELEFLEX MEDICAL
K063778 12/21/2006 FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE TELEFLEX MEDICAL
K970983 03/18/1997 PERITONEAL/CARDIAC CATHETER INTEGRA NEUROCARE LLC.
K971617 05/02/1997 ENDOSCOPIC VENTRICULAR CATHETER INTEGRA NEUROCARE LLC.
K972261 06/17/1997 RIVETTI-LEVINSON INSTRALUMINAL SHUNT INTEGRA NEUROCARE LLC.
K972994 08/12/1997 EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS INTEGRA NEUROCARE LLC.
K974708 12/17/1997 GEMINI STANDARD AND MINI VALVES NEUROCARE GROUP
K973525 09/17/1997 MAURICE WORLDWIDE SHUNT SYSTEM INTEGRA NEUROCARE LLC.
K030800 03/13/2003 ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES ELETROMED, INC.
K970510 02/11/1997 INNOFLOUR TOPIRAMATE REAGENT SET OXIS INTL., INC.
K970517 02/11/1997 INNOFLUOR TOPIRAMATE CONTROL SET OXIS INTL., INC.
K970509 02/11/1997 INNOFLOUR CALIBRATOR REAGENT SET OXIS INTL., INC.
K972330 06/23/1997 INNOFLUOR PHENOBARBITAL ASSAY SYSTEM OXIS INTL., INC.
K972331 06/23/1997 INNOFLUOR GENTAMICIN ASSAY SYSTEM OXIS INTL., INC.
K955568 12/06/1995 INNOFLUOR QUINIDINE ASSAY SYSTEM OXIS INTL., INC.
K955569 12/06/1995 INNOFLUOR GENTAMICIN ASSAY SYSTEM OXIS INTL., INC.
K955570 12/06/1995 INNOFLUOR AMIKACIN ASSAY SYSTEM OXIS INTL., INC.
K955567 12/06/1995 INNOFLUOR THEOPHYLLINE ASSAY SYSTEM OXIS INTL., INC.
K955562 12/06/1995 INNOFLUOR PHENYTOIN ASSAY SYSTEM OXIS INTL., INC.
K955002 11/01/1995 MAHURKAR 8 FR DUAL LEMEN CATHETER QUINTON, INC.
K955047 11/03/1995 WESTMED CIRCULARIE PEP DEVICES WESTMED INTL.
K180854 04/02/2018 Voyager Trajectory Array Guide (V-TAG) Voyager Therapeutics, Inc.


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