FDA 510(k) Applications Submitted by Vi Ma

FDA 510(k) Number Submission Date Device Name Applicant
K220439 02/16/2022 Viz SDH Viz.ai, Inc.
K221100 04/14/2022 Viz RV/LV Viz.ai, Inc.
K201510 06/05/2020 Traufix osteosynthesis, osteotomy, and arthrodesis devices Fixier, S.A. de C.V.
K931647 04/05/1993 PHOENIX 4.0 MM HA COATED DENTAL IMPLANT VANCOUVER IMPLANT CENTER
K002640 08/24/2000 FREEDOM AUTOMATIC FILM PROCESSOR J. MORITA USA, INC.
K150799 03/26/2015 Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula INNOVACYN, INC.
K970285 01/24/1997 AESUCLAP SOCON SPINAL SYSTEM AESCULAP, INC.
K960470 02/01/1996 NEURO-PATCH AESCULAP, INC.
K970549 02/12/1997 TITANIUM ALLOY BONE SCREWS AESCULAP, INC.
K970851 03/07/1997 LYOPLANT DURA SUBSTITUTE(VARIOUS) AESCULAP, INC.
K122003 07/09/2012 RENEW INSERT RENEW MEDICAL, INC.
K062028 07/18/2006 CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 CELERA DIAGNOSTICS
K954394 09/18/1995 AESCULAP VENTRICULOSCOPE SYSTEM AESCULAP, INC.
K983758 10/26/1998 YASARGIL TITANIUM ANEURYSM CLIPS AESCULAP, INC.
K970050 01/06/1997 YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) AESCULAP, INC.
K111804 06/27/2011 INTELLISPACE PACS 4.X PHILIPS HEALTHCARE INFORMATICS, INC.
K190559 03/05/2019 SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports AngioDynamics, Inc.
K993782 11/08/1999 SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9) P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
K993781 11/08/1999 SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
K993779 11/08/1999 SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
K230561 02/28/2023 Syngo Carbon Space VA30A Siemens Healthcare GmBH
K180563 03/05/2018 syngo.plaza Siemens Healthcare GmbH
K213665 11/22/2021 Syngo Carbon Space VA20A Siemens Healthcare GmbH
K052460 09/07/2005 POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE RAMSOFT, INC.
K994419 12/29/1999 FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM QUALISYS DIAGNOSTICS, INC.
K020244 01/24/2002 SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) SYNTHES SPINE
K030377 02/05/2003 MODIFICATION TO SYNTHES CERVIFIX SYSTEM SYNTHES (USA)
K020517 02/19/2002 SYNTHES DUAL-OPENING USS SYNTHES (USA)
K022791 08/22/2002 SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM SYNTHES (USA)
K022949 09/05/2002 SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS SYNTHES (USA)
K002849 09/13/2000 PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES SURGICAL SPECIALTIES CORP.
K003015 09/27/2000 SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD SURGICAL SPECIALTIES CORP.
K023675 11/01/2002 SYNTHES CERVIFIX/ AXON SYNTHES (USA)
K023862 11/20/2002 NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER SYNTHES (USA)
K070069 01/08/2007 ZIPPREP ELECTRODE ASPECT MEDICAL SYSTEMS, INC.
K220916 03/30/2022 iLet« Dosing Decision Software Beta Bionics, Inc.
K091854 06/19/2009 BIS CLICK SENSOR/CABLE ASPECT MEDICAL SYSTEMS, INC.
K072286 08/16/2007 BIS EEG VISTA MONITOR SYSTEM AND BISX ASPECT MEDICAL SYSTEMS, INC.
K062613 09/05/2006 BIS EEG MONITOR VIEW ASPECT MEDICAL SYSTEMS, INC.
K093183 10/09/2009 BIS QUATRO SENSOR ASPECT MEDICAL SYSTEMS, INC.
K223846 12/20/2022 iLet« ACE Pump Beta Bionics, Inc
K200487 02/27/2020 RayCare 3.1 RaySearch Laboratories AB (publ)
K200569 03/04/2020 RayStation RaySearch Laboratories AB (publ)
K202459 08/27/2020 Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter Pharma System AB
K200258 02/03/2020 Edwards eSheath Introducer Set Edwards Lifesciences
K221768 06/17/2022 Oxfore«100 (hexafocon A) Rigid Gas Permeable Contact Lenses Paragon Vision Sciences, Inc.
K163383 12/01/2016 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System GREENS SURGICALS PVT. LTD.
K011012 04/04/2001 POWDER FREE NITRILE EXAMINATION GLOVE CONTRACT LATEX DIPPERS SDN BHD
K983568 10/13/1998 OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER CONTRACT LATEX DIPPERS SDN BHD
K983570 10/13/1998 GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE GLOVE SEAL SDN BHD
K223509 11/22/2022 Compremium Compartment Compressibility Monitoring System (CPM#1) Compremium AG
K190486 02/28/2019 Pitkar External Fixation System S H Pitkar Orthotools Pvt Ltd.
K200518 03/02/2020 Pitkar External Fixation System - Rail Mechanism S H Pitkar Orthotools Pvt Ltd
K200728 03/20/2020 Pitkar DeftFix System S H Pitkar Orthotools Pvt Ltd.
K192619 09/23/2019 Pitkar Locked Plating System S H Pitkar Orthotools Pvt Ltd.
K082071 07/22/2008 ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT ADPHARMA, INC.
K120811 03/16/2012 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB


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