FDA 510(k) Applications Received During June, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K181643 06/22/2018 SmartBag (SmartPouch) 11 Health Technologies Limited Michael Seres
DEN180028 06/05/2018 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports 23andMe, Inc. Adam Odeh
K181607 06/19/2018 Thorecon Rigid Fixation System A&E Medical Corporation Dana Rodriguez
K181471 06/04/2018 ACCUFUSE Cervical System Absolute Advantage Medical, LLC J.D. Webb
K181471 06/04/2018 ACCUFUSE Cervical System Absolute Advantage Medical, LLC J.D. Webb
K181563 06/14/2018 The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology Access Scientific, LLC Martina Nguyen
K181527 06/11/2018 On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K181544 06/12/2018 Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation Lisa Theama
K181544 06/12/2018 Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation Lisa Theama
K181585 06/15/2018 JGH1 Core Deccompression Procedure Kit AgNovos Healthcare USA, LLC Felipe Aguel
K181585 06/15/2018 JGH1 Core Deccompression Procedure Kit AgNovos Healthcare USA, LLC Felipe Aguel
K181482 06/05/2018 myTAP2 Airway Management, Inc. Eric Jarrett
K181482 06/05/2018 myTAP2 Airway Management, Inc. Eric Jarrett
K181454 06/04/2018 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc. Sherri Lakota
K181453 06/01/2018 ATEC ALIF Spacer System Alphatec Spine, Inc. Cynthia Adams
K181453 06/01/2018 ATEC ALIF Spacer System Alphatec Spine, Inc. Cynthia Adams
K181435 06/01/2018 ATEC Cervical Spacer System Alphatec Spine, Inc. Cynthia Adams
K181435 06/01/2018 ATEC Cervical Spacer System Alphatec Spine, Inc. Cynthia Adams
K181677 06/26/2018 Kodiak Spinal Fixation System Alphatec Spine, Inc. Cynthia Adams
K181677 06/26/2018 Kodiak Spinal Fixation System Alphatec Spine, Inc. Cynthia Adams
K181617 06/19/2018 E-CUBE 8 Alpinion Medical Systems Co., Ltd. Boyeon CHO
K181445 06/01/2018 AMSure Hydrophilic Intermittent Catheter Amsino International Inc. Zoe Wu
K181555 06/13/2018 Arthrex Fracture Adapter Hemi Shoulder Prosthesis Arthrex Inc. David L. Rogers
K181513 06/08/2018 Arthrex PushLock Tenodesis Anchor Arthrex Inc. Ivette Galmez
K181513 06/08/2018 Arthrex PushLock Tenodesis Anchor Arthrex Inc. Ivette Galmez
K181474 06/04/2018 ArtiClip LAA Exclusion System AtriCure, Inc. Jonathan McElwee
K181474 06/04/2018 ArtiClip LAA Exclusion System AtriCure, Inc. Jonathan McElwee
K181465 06/04/2018 SpaceOAR System Augmenix, Inc. Marcus Garcia
K181465 06/04/2018 SpaceOAR System Augmenix, Inc. Marcus Garcia
K181725 06/29/2018 Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) Avenu Medical, Inc. Rebecca K. Pine
K181627 06/20/2018 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner Bausch & Lomb Incorporated Melissa Thomas
K181627 06/20/2018 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner Bausch & Lomb Incorporated Melissa Thomas
K181718 06/29/2018 BD FlowSmart Set/MiniMed Pro-Set Becton, Dickinson and Company Meriam Youssef
K181427 06/01/2018 BD MAX Enteric Viral Panel, BD MAX Instrument Becton, Dickinson and Company Laura Stewart
K181665 06/25/2018 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN Becton,Dickinson and Company Monica E. Giguere
K181503 06/07/2018 Fingertip Pulse Oximeter Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao
K181493 06/06/2018 FilmArray Blood Culture Identification (BCID) Panel BioFire Diagnostics, LLC Kristen J. Kanack
K181493 06/06/2018 FilmArray Blood Culture Identification (BCID) Panel BioFire Diagnostics, LLC Kristen J. Kanack
K181565 06/14/2018 Aquarius 8600 Digital Radiography Sensor Biokinemetrics Inc. Steven Kraus
K181565 06/14/2018 Aquarius 8600 Digital Radiography Sensor Biokinemetrics Inc. Steven Kraus
K181611 06/19/2018 Comprehensive Reverse Shoulder System Biomet Manufacturing Corp Dalene Binkley
K181554 06/13/2018 Stowe Pedicle Screw System Black Box Medical Todd Stanaford
K181554 06/13/2018 Stowe Pedicle Screw System Black Box Medical Todd Stanaford
K181439 06/01/2018 SpyGlass DS and DS II Direct Visualization System Boston Scientific Corporation Carter Navarro
K181439 06/01/2018 SpyGlass DS and DS II Direct Visualization System Boston Scientific Corporation Carter Navarro
K181497 06/07/2018 HPM-6000UF BTL Industries, Inc. David Chmel
K181466 06/04/2018 Cadwell Zenith System Cadwell Industries, Inc. Alison Hull
K181466 06/04/2018 Cadwell Zenith System Cadwell Industries, Inc. Alison Hull
K181670 06/25/2018 Alphenix, INFX-8000V/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181670 06/25/2018 Alphenix, INFX-8000V/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181646 06/22/2018 Celesteion, PCA-9000A/3, V6.5 Canon Medical Systems Corporation Paul Biggins
K181593 06/18/2018 Vantage Galan 3T, MRT-3020/A7, V5.0 Canon Medical Systems Corporation Paul Biggins
K181593 06/18/2018 Vantage Galan 3T, MRT-3020/A7, V5.0 Canon Medical Systems Corporation Paul Biggins
K181444 06/01/2018 CLARUS Carl Zeiss Meditec, Inc. Saurabh Jamkhindikar
K181667 06/25/2018 Thoraguard System Centese, Inc. Evan Luxon
K181540 06/11/2018 Estremo Citieffe Nailing System CITIEFFE S.r.L. Stefano Pullega
K181500 06/07/2018 BRILLIANT Crios Coltene/Whaledent AG Daniel Meier
K181500 06/07/2018 BRILLIANT Crios Coltene/Whaledent AG Daniel Meier
K181566 06/14/2018 Nutrifill Contamac Ltd. Rob McGregor
K181529 06/11/2018 Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection Contego Medical, LLC Elizabeth Saylors
K181463 06/04/2018 DuraSheath Introducer Sheath System Contract Medical International GmbH Jan Kloboucnik
K181431 06/01/2018 Laser Ureteral Catheter Cook Incorporated Carly Powell
K181431 06/01/2018 Laser Ureteral Catheter Cook Incorporated Carly Powell
K181712 06/28/2018 San Antonio Stopcock Cook Incorporated James O. Ebot Rnaw
K181712 06/28/2018 San Antonio Stopcock Cook Incorporated James O. Ebot Rnaw
K181713 06/28/2018 Ultraxx Nephrostomy Balloon Catheter Set Cook Incorporated Minjin Choi
K181713 06/28/2018 Ultraxx Nephrostomy Balloon Catheter Set Cook Incorporated Minjin Choi
K181592 06/18/2018 RAIN Sheath Transradial Cordis Corporation Ankita Phophalia
K181592 06/18/2018 RAIN Sheath Transradial Cordis Corporation Ankita Phophalia
K181580 06/15/2018 Cortex CAD/CAM Abutments Cortex Dental Implants Industries Ltd. Ronit Polack
K181434 06/01/2018 SporView Rapid Read Biological Indicator SteamPlus Test Pack Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar
K181721 06/29/2018 Ceracell Ortho Foam curasan AG Gregor Thomas
K181562 06/14/2018 Curiteva Anterior Cervical Plate System Curiteva, LLC Eric Linder
K181562 06/14/2018 Curiteva Anterior Cervical Plate System Curiteva, LLC Eric Linder
K181589 06/18/2018 Curiteva Lumbar Interbody Fusion System Curiteva, LLC Eric Linder
K181549 06/12/2018 Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) Curiteva, LLC Eric Linder
K181549 06/12/2018 Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) Curiteva, LLC Eric Linder
K181582 06/15/2018 DemeTECH DemeDIOX absorbable surgical suture Demetech Corporation Linda Hernandez
K181582 06/15/2018 DemeTECH DemeDIOX absorbable surgical suture Demetech Corporation Linda Hernandez
K181578 06/15/2018 DemeTECH PTFE Nonabsorbable Surgical Suture Demetech Corporation Linda Hernandez
K181476 06/05/2018 Prime&Bond active Universal Adhesive Dentsply Sirona Karl Nittinger
K181520 06/11/2018 Sirona Dental CAD/CAM System Dentsply Sirona Karl J. Nittinger
K181464 06/04/2018 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set DiaSorin Inc. John C. Walter
K181464 06/04/2018 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set DiaSorin Inc. John C. Walter
K181438 06/01/2018 Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay Diazyme Laboratories Inc. Abhijit Datta
K181438 06/01/2018 Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay Diazyme Laboratories Inc. Abhijit Datta
K181432 06/01/2018 ProVectra 3D Prime with VistaSoft Durr Dental SE Oliver Lange
K181432 06/01/2018 ProVectra 3D Prime with VistaSoft Durr Dental SE Oliver Lange
K181579 06/15/2018 eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K E&E Optics Inc. Bonnie Wan
K181579 06/15/2018 eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K E&E Optics Inc. Bonnie Wan
K181574 06/15/2018 Uscan EchoNous, Inc. Trish Liau
K181574 06/15/2018 Uscan EchoNous, Inc. Trish Liau
K181547 06/12/2018 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens Karine Bonenfant
K181547 06/12/2018 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens Karine Bonenfant
K181684 06/26/2018 VAMP Plus Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC Ye Seul Kim
K181498 06/07/2018 X-ray Imaging System for the McLaren Proton Treatment System EhmetDx, LLC Daniel Schoettlin
K181644 06/22/2018 EIT Cellular Titanium« Lumbar Cage LLIF EIT Emerging Implant Technologies GmbH Barbara Wirth
K181609 06/19/2018 RadiForce GX560, GX560-AR EIZO Corporation Hiroaki Hashimoto
K181609 06/19/2018 RadiForce GX560, GX560-AR EIZO Corporation Hiroaki Hashimoto
K181510 06/08/2018 ECHOLASER X4 El.En Electronic Engineering Spa Paolo Peruzzi
K181486 06/06/2018 DEKA Motus AY Elen Electronic Engineering Spa Paolo Peruzzi
K181486 06/06/2018 DEKA Motus AY Elen Electronic Engineering Spa Paolo Peruzzi
K181720 06/29/2018 Epiphany Cardio Server Mobile Epiphany Healthcare, LLC Pat White
K181720 06/29/2018 Epiphany Cardio Server Mobile Epiphany Healthcare, LLC Pat White
K181653 06/22/2018 Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed Ethicon Endo-Surgery, LLC Sigfrido Delgado
K181488 06/06/2018 LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier Ethicon Endo-Surgery, LLC Sigfrido Delgado
K181652 06/22/2018 Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture Ethicon, Inc. Donna Marshall
K181707 06/28/2018 Everyway Wireless TENS & EMS Unit Everyway Medical Instruments Co., Ltd. Paul Hung
K181532 06/11/2018 Exactech Alteon Monobloc Revision Stem Exactech, Inc. Zach Sharrah
K181642 06/21/2018 B-Laser Atherectomy System Eximo Medical Ltd. Yossi Muncher
K181620 06/20/2018 Endoscopic Linear Cutting Staplers and Loading Units for Single Use Ezisurg (Suzhou) Medical Co., Ltd. Renjing Tian
K181657 06/22/2018 easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use Ezisurg Medical Co., Ltd. Liang Xia
K181690 06/26/2018 Clear-Jet Injection Catheter Finemedix Co. Ltd. Hee Kyung Kwon
K181583 06/15/2018 Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Si Flexicare Medical Limited Joel Biddle
K181685 06/26/2018 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K181727 06/29/2018 Vivid iq GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K181558 06/13/2018 Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens Gelflex Laboratories David Masel
K181663 06/25/2018 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel GenMark Diagnostics, Incorporated Alan Maderazo
K181586 06/15/2018 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K181586 06/15/2018 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K181696 06/27/2018 ChitoZolve Gyrus ACMI, Inc Dolan Mills
K181700 06/27/2018 HardyDisk AST Plazomicin 30ug (PLZ30) Hardy Diagnostics Anna Klavins
K181700 06/27/2018 HardyDisk AST Plazomicin 30ug (PLZ30) Hardy Diagnostics Anna Klavins
K181692 06/27/2018 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) Health Beacons, Inc. Nancy Confrey
K181594 06/18/2018 Spectralis HRA+OCT and variants with OCT Angiography Module Heidelberg Engineering GmbH Christoph Schoess
K181468 06/04/2018 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K181676 06/25/2018 Mini Ridge Filter and auxiliary functions for PROBEAT-V Hitachi Ltd. Healthcare Hitachi Works Tomoyuki Seino
K181676 06/25/2018 Mini Ridge Filter and auxiliary functions for PROBEAT-V Hitachi Ltd. Healthcare Hitachi Works Tomoyuki Seino
K181604 06/19/2018 Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite HRS Co., Ltd. Seunghwan Go
K181680 06/26/2018 ICONN Answer II Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K181680 06/26/2018 ICONN Answer II Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K181553 06/13/2018 Immunalysis Ethyl Alcohol Enzyme Assay Immunalysis Corporation Weying (Jessica) Zhu
K181694 06/27/2018 Apiration Guide Catheter, Retraction Aspirator, FlowTriever Catheter Inari Medical Eben Gordon
K181694 06/27/2018 Apiration Guide Catheter, Retraction Aspirator, FlowTriever Catheter Inari Medical Eben Gordon
K181473 06/04/2018 DENV Detect NS1 ELISA InBios International, Inc. Estela Raychaudhuri
K181473 06/04/2018 DENV Detect NS1 ELISA InBios International, Inc. Estela Raychaudhuri
K181458 06/04/2018 Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter Innovative Health, LLC. Amanda Babcock
K181618 06/19/2018 Reprocessed Torqr Diagnostic EP Catheter Innovative Health, LLC. Amanda Babcock
K181584 06/15/2018 Redi-Spine Innovative Surgical Designs, Inc. Jon Rinehart
K181584 06/15/2018 Redi-Spine Innovative Surgical Designs, Inc. Jon Rinehart
K181703 06/27/2018 Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments Institut Straumann AG Viviana Horhoiu
K181639 06/21/2018 Panta 2 Arthrodesis Nail System Integra Lifesciences Corporation Blesson Abraham
K181502 06/07/2018 Zio AT ECG Monitoring System, ZEUS System iRhythm Technologies, Inc. Rich Laguna
K181502 06/07/2018 Zio AT ECG Monitoring System, ZEUS System iRhythm Technologies, Inc. Rich Laguna
K181662 06/25/2018 Iridex TruFocus LIO Premiere Iridex Corporation Edward J. Sinclair
K181603 06/19/2018 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System K2M Inc. Nancy Giezen
K181469 06/04/2018 Cryotop«US-flash and Cryotop«US-scoop Kitazato Corporation Futoshi Inoue
K181600 06/18/2018 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. Jihyeon Seo
K181600 06/18/2018 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. Jihyeon Seo
K181537 06/11/2018 GLOW800 Leica Microsystems (Schweiz) AG Georges Hakim
K181430 06/01/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) LENSAR, Inc. Keith Peck
K181430 06/01/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) LENSAR, Inc. Keith Peck
K181717 06/28/2018 Life Spine Laminoplasty System Life Spine Inc. Angela Batker
K181625 06/20/2018 Life Spine ResoluteÖ Threaded Cage System Life Spine Inc. Angela Batke
K181708 06/28/2018 MTS Plazomicin 0.016-256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K181708 06/28/2018 MTS Plazomicin 0.016-256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K181559 06/13/2018 Neurosign V4 Intraoperative Nerve Monitor Magstim Company Ltd. Tom Campbell
K181635 06/21/2018 GMK Sphere CR Tibial Inserts Medacta International SA Stefano Baj
K181635 06/21/2018 GMK Sphere CR Tibial Inserts Medacta International SA Stefano Baj
K181693 06/27/2018 SMS Femoral Stem Medacta International SA Stefano Baj
K181591 06/18/2018 Fixated Asfora BULLET CAGE« (FABC) Medical Designs, LLC Kristi Vondra
K181568 06/14/2018 IPL Salon Hair Reduction System Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt Bruce Wu
K181543 06/12/2018 CureÖ OPEL-C Plate System Meditech Spine, LLC Bruce Dunaway
K181543 06/12/2018 CureÖ OPEL-C Plate System Meditech Spine, LLC Bruce Dunaway
K181726 06/29/2018 Medline Patient Cables and Lead Wires Medline Industries, Inc. Dinah Rincones
K181622 06/20/2018 StrataMR guider tool Medtronic Neurosurgery Xiaojian Sun
K181689 06/26/2018 Nexcomp Meta Biomed Co., Ltd. Suk Song Oh
K181683 06/26/2018 BD MAX CT/GC/TV 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181683 06/26/2018 BD MAX CT/GC/TV 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181711 06/28/2018 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181711 06/28/2018 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181499 06/07/2018 DRI Cocaine Metabolite Assay Microgenics Corporation Emily Chien
K181499 06/07/2018 DRI Cocaine Metabolite Assay Microgenics Corporation Emily Chien
DEN180030 06/25/2018 QMS Plazomicin Immunoassay Microgenics Corporation Minoti Patel
K181598 06/18/2018 Prime E-CLASS XLPE Liner MicroPort Orthopedics Inc. Sarah Evonne Stroupe
K181666 06/25/2018 Smart One MIR Medical International Research Gerda Van Houts
K181666 06/25/2018 Smart One MIR Medical International Research Gerda Van Houts
K181572 06/14/2018 Workflow Box Mirada Medical Ltd. Gwilym Owen
K181572 06/14/2018 Workflow Box Mirada Medical Ltd. Gwilym Owen
K181623 06/20/2018 Clarifi Imaging System Modulated Imaging, Inc. David Cuccia
K181623 06/20/2018 Clarifi Imaging System Modulated Imaging, Inc. David Cuccia
K181437 06/01/2018 Pure Vu System Motus GI Medical Technologies Ltd. Hagit Ephrath
K181437 06/01/2018 Pure Vu System Motus GI Medical Technologies Ltd. Hagit Ephrath
K181731 06/29/2018 MR Compatible Aspiration Kit MRI Interventions, Inc. Pete Piferi
K181590 06/18/2018 Neurostructures Cavetto« [MAX] Cervical Cage System NeuroStructures, Inc. Kathleen Wong
K181709 06/28/2018 Serenity Piezo Sensor, Serenity Thermocouple Sensor Neurotronics, Inc. David Pezet
K181501 06/07/2018 Afina NeuroVision Imaging, LLC Pepe Davis
K181621 06/20/2018 Stable-C Interbody System Nexus Spine, LLC Jared Crocker
K181483 06/05/2018 Tranquil Interbody System Nexus Spine, LLC Jared Crocker
K181483 06/05/2018 Tranquil Interbody System Nexus Spine, LLC Jared Crocker
K181702 06/27/2018 Tranquil-L Interbody System Nexus Spine, LLC Jared Crocker
K181695 06/27/2018 Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden OrangeMed, Inc. Sheryl Higgins
K181451 06/01/2018 URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R Olympus Medical Systems Corp. Toshiyuki Nakajima
K181460 06/04/2018 OnePacs System OnePacs, LLC Justin Falk
K181569 06/14/2018 BKS Revision Sleeves System Ortho Development Corporation Dan Petersen
K181449 06/01/2018 Ortoma Treatment Solution - OTS Ortoma AB Linus Bystrom
K181539 06/11/2018 OSSDSIGN Cranioplug OssDsign AB Ulrik Birgersson
K181616 06/19/2018 PSM 3-Way Silicone Foley Catheter Pathway, LLC David Stroup
K181522 06/11/2018 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope PENTAX of America, Inc. William Goeller
K181522 06/11/2018 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope PENTAX of America, Inc. William Goeller
K181556 06/13/2018 EliA M2 Immunoassay Phadia AB Carina Magnusson
K181556 06/13/2018 EliA M2 Immunoassay Phadia AB Carina Magnusson
K181479 06/05/2018 Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V. Jan Van de Kerkhof
K181479 06/05/2018 Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V. Jan Van de Kerkhof
K181485 06/06/2018 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Kym Rupp
K181485 06/06/2018 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Kym Rupp
K181576 06/15/2018 Planmeca Viso Planmeca Oy Lars Moring
K181659 06/25/2018 Avologi ENEO Premier North America Inc. Yaniv Applicant
K181659 06/25/2018 Avologi ENEO Premier North America Inc. Yaniv Applicant
K181455 06/04/2018 ProSun sunlamp products, Luxura sunlamp products ProSun International LLC Tom Henkemans
K181697 06/27/2018 16ch Foot/ Ankle SPEEDER Quality Electrodynamics, LLC Eric Yeh
K181697 06/27/2018 16ch Foot/ Ankle SPEEDER Quality Electrodynamics, LLC Eric Yeh
K181632 06/20/2018 Venacure 1470 Pro Quanta System Spa Francesco Dell'Antonio
K181651 06/22/2018 Radial Medical Compression System Radial Medical, Inc. Eric Johnson
K181452 06/01/2018 RCT800 Ray Co., Ltd. Changhwan Lee
K181452 06/01/2018 RCT800 Ray Co., Ltd. Changhwan Lee
K181706 06/28/2018 neuromate Gen III Renishaw Mayfield Sarl Stephane Vinot
K181706 06/28/2018 neuromate Gen III Renishaw Mayfield Sarl Stephane Vinot
K181655 06/22/2018 Renovis S180 Lateral Lumbar Interbody Fusion System Renovis Surgical Technologies Anthony Debenedictis
K181495 06/06/2018 Republic Spine Dark Star Spinal System Republic Spine, L.L.C. James Doulgeris
K181495 06/06/2018 Republic Spine Dark Star Spinal System Republic Spine, L.L.C. James Doulgeris
K181492 06/06/2018 Elecsys CA 15-3 II Roche Diagnostics Adennis Cora
K181492 06/06/2018 Elecsys CA 15-3 II Roche Diagnostics Adennis Cora
K181626 06/20/2018 Digital Diagnostic Mobile X-ray System Samsung Electronics Co., Ltd. Chang Soeun
K181626 06/20/2018 Digital Diagnostic Mobile X-ray System Samsung Electronics Co., Ltd. Chang Soeun
K181629 06/20/2018 GC85A Samsung Electronics Co., Ltd. Noh Jaesang
K181629 06/20/2018 GC85A Samsung Electronics Co., Ltd. Noh Jaesang
K181631 06/20/2018 GR40CW Samsung Electronics Co., Ltd. Noh Jaesang
K181631 06/20/2018 GR40CW Samsung Electronics Co., Ltd. Noh Jaesang
K181704 06/27/2018 Transpara ScreenPoint Medical BV Nico Karssemeijer
K181518 06/08/2018 Sebacia Microparticles Sebacia, Inc. Todd J. Meyer
K181436 06/01/2018 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test Sekisui Diagnostics, LLC Shelly Harris
K181436 06/01/2018 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test Sekisui Diagnostics, LLC Shelly Harris
K181728 06/29/2018 Muscle Trainer Shenzhen Kentro Medical Electronics Co., Ltd Zewu Zhang
K181637 06/21/2018 DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Zhang Wei
K181688 06/26/2018 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang
K181496 06/07/2018 VINTAGE PRO Shofu Dental Corporation Mauro Malzyner
K181525 06/11/2018 INNOVANCE Free PS Ag Siemens Healthcare Diagnostics Products GmbH Petra Dissmann
K181550 06/13/2018 Cios Spin Siemens Medical Solutions USA, Inc. Patricia D. Jones
K181613 06/19/2018 MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D Siemens Medical Solutions USA, Inc. Cordell L. Fields
K181433 06/01/2018 MAGNETOM Vida Siemens Medical Solutions USA, Inc. Martin Rajchel
K181560 06/14/2018 Cios Alpha Siemens Medical Systems USA, Inc. Patricia D. Jones
K181530 06/11/2018 World Total Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
K181509 06/08/2018 Endorate Valve Sets Smartdata Suzhou Co., Ltd Cindy Ye
K181509 06/08/2018 Endorate Valve Sets Smartdata Suzhou Co., Ltd Cindy Ye
K181533 06/11/2018 EVOS Wrist Fracture Plating System Smith & Nephew, Inc. Bryan Cowell
K181533 06/11/2018 EVOS Wrist Fracture Plating System Smith & Nephew, Inc. Bryan Cowell
K181699 06/27/2018 Level 1 Convective Warmer Smiths Medical ASD, Inc. Donna M. Semlak
K181699 06/27/2018 Level 1 Convective Warmer Smiths Medical ASD, Inc. Donna M. Semlak
K181636 06/21/2018 Aurora Sodium Systems, LLC Brandon Bachler
K181636 06/21/2018 Aurora Sodium Systems, LLC Brandon Bachler
K181440 06/01/2018 Proficient« Posterior Cervical Spine System Spine Wave, Inc. Amy Noccioli
K181440 06/01/2018 Proficient« Posterior Cervical Spine System Spine Wave, Inc. Amy Noccioli
K181596 06/18/2018 Spine Wave Navigated Instruments Spine Wave, Inc. Amy Noccioli
K181531 06/11/2018 SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices SpineEX Inc. Andrew Rogers
K181608 06/19/2018 Disposable Standard Clamp Standard Bariatrics Alison Sathe
K181429 06/01/2018 CELERITY 20 HP Biological Indicator STERIS Corporation Anthony Piotrkowski
K181429 06/01/2018 CELERITY 20 HP Biological Indicator STERIS Corporation Anthony Piotrkowski
K181686 06/26/2018 CELERITY 20 Steam Biological Indicator STERIS Corporation Tony Piotrkowski
K181686 06/26/2018 CELERITY 20 Steam Biological Indicator STERIS Corporation Tony Piotrkowski
K181442 06/01/2018 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation Anthony Piotrkowski
K181442 06/01/2018 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation Anthony Piotrkowski
K181480 06/05/2018 MMD Tip Strata Skin Sciences, Inc. Shmuel Gov
K181480 06/05/2018 MMD Tip Strata Skin Sciences, Inc. Shmuel Gov
K181504 06/07/2018 Stryker Pediatric Mandibular Distractor 2 Stryker Gregory Gohl
K181523 06/11/2018 Syneron CO2RE System Syneron-Candela Corp Sharon Timberlake
K181523 06/11/2018 Syneron CO2RE System Syneron-Candela Corp Sharon Timberlake
K181675 06/25/2018 FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System TaiDoc Technology Corporation Yvette Chang
K181588 06/15/2018 POPS! one Blood Glucose Monitoring System TaiDoc Technology Corporation Anne Kuo
K181587 06/15/2018 ORTHOLOC SPS Shoulder Plating System Tornier Inc. Renee Stoffel
K181517 06/08/2018 Senhance Surgical System TransEnterix, Inc. Kaitlyn Alexander
K181649 06/22/2018 AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) Trudell Medical International Marianne Tanton
K181612 06/19/2018 Tyto Stethoscope (OTC) Tyto Care Ltd. Stella Raizelman Perry
K181526 06/11/2018 XRpad2 4343 HWC-M Flat Panel Detector Varex Imaging Corporation Paul Sawicki
K181526 06/11/2018 XRpad2 4343 HWC-M Flat Panel Detector Varex Imaging Corporation Paul Sawicki
K181647 06/22/2018 Bandit guidewire Vascular Solutions, Inc. Becky Astrup
K181647 06/22/2018 Bandit guidewire Vascular Solutions, Inc. Becky Astrup
K181461 06/04/2018 Rapid-iÖ Kit Vitrolife Sweden AB Nina Arvidsson
K181524 06/11/2018 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART Vyaire Medical, Inc. Elmar Niedermeyer
K181557 06/13/2018 INFINITY Total Ankle System Wright Medical Technology, Inc. Tara Conrad
K181557 06/13/2018 INFINITY Total Ankle System Wright Medical Technology, Inc. Tara Conrad
K181640 06/21/2018 X-BOLT Hip Fracture Fixation System X-Bolt Orthopaedics Brian Thornes
K181641 06/21/2018 QuikClot Radial Z-Medica, LLC Sheila K. Wallin
K181484 06/05/2018 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue Zirkonzahn Srl Sandra Leitner
K181484 06/05/2018 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue Zirkonzahn Srl Sandra Leitner


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