FDA 510(k) Applications Received During July, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K181838 07/10/2018 Sinusway Dilation System 3NT Medical Ltd. Ehud Bendory
K181748 07/02/2018 Magnesium Abbott Laboratories Mark Littlefield
K181908 07/17/2018 Action Trackchair Action Manufacturing Inc. Alan Macht
K181887 07/13/2018 AMD Anti-Fog Solution Advanced Medical Design Co., Ltd Silvia Yeh
K182032 07/30/2018 SterilContainer S System Aesculap, Inc. Paul Amudala
K181911 07/17/2018 Interlude 100% Cotton Tampon ALBAAD fem Shlomo Helvits
K181796 07/05/2018 FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions Alcon Laboratories, Inc. Sherri Lakota
K181796 07/05/2018 FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions Alcon Laboratories, Inc. Sherri Lakota
K181853 07/11/2018 Alere BinaxNOW Influenza A & B Card 2, Alere Reader Alere Scarborough, Inc. Angela Drysdale
K181853 07/11/2018 Alere BinaxNOW Influenza A & B Card 2, Alere Reader Alere Scarborough, Inc. Angela Drysdale
K182053 07/31/2018 UltravisionÖ Visual Field Clearing System Alesi Surgical Ltd. David Broderick
K181739 07/02/2018 Invisalign System with Mandibular Advancement Feature Align Technology, Inc. Somi Ekwealor
K182054 07/31/2018 Natrelle 133S Tissue Expander Allergan Melissa Pathmajeyan
K182054 07/31/2018 Natrelle 133S Tissue Expander Allergan Melissa Pathmajeyan
K181980 07/25/2018 OsseoScrew System Alphatec Spine, Inc. Jeremy Markovich
K181910 07/17/2018 BracePaste MTP Light Cure Primer American Orthodontics Trang Adams
K181814 07/09/2018 AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water Amsino International, Inc. Cathy Hong
K181926 07/18/2018 InVivo Web Viewer Anatomage Inc. Changxin Xu
K182024 07/30/2018 Dissecting Balloon System Applied Medical Resources Corp. Corinne Yestrepsky
K182024 07/30/2018 Dissecting Balloon System Applied Medical Resources Corp. Corinne Yestrepsky
K181756 07/02/2018 Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle AprioMed AB Katrin Svensson
K181935 07/19/2018 Endoform Reconstructive Template - Non Absorbable Aroa Biosurgery Ltd. Tina O'Brien
K182034 07/30/2018 Arterys MICA Arterys Inc. Sharon Cholowsky
K182039 07/30/2018 Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay Arthrex Inc. Courtney Smith
K181769 07/03/2018 Arthrex FiberTak Suture Anchor Arthrex, Inc. David L. Rogers
K181768 07/03/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K181768 07/03/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K182012 07/27/2018 ADVIA Centaur Calcitonin (CALCT) assay Axis-Shield Diagnostics Limited Claire Dora
K181864 07/12/2018 Polaris RF Ablation System Baylis Medical Company Inc. May Tsai
K181737 07/02/2018 Raycell MK1 Best Theratronics Limited Mojgan Soleimani
K181821 07/09/2018 MOSS VRS Spinal System Biedermann Motech GmbH & Co. KG Gerd Federle
K181766 07/03/2018 VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance bioMerieux, Inc Cherece L. Jones
K182030 07/30/2018 Faros Mobile Bittium Biosignals Ltd. Taneli Vaaraniemi
K181785 07/03/2018 Modified BrainScope One BrainScope Company Inc. Michael E Singer
K181804 07/06/2018 Alphenix, INFX-8000C/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181804 07/06/2018 Alphenix, INFX-8000C/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181834 07/10/2018 Ultimax-i, DREX-UI80 (V1.60) Canon Medical Systems Corporation Paul Biggins
K181834 07/10/2018 Ultimax-i, DREX-UI80 (V1.60) Canon Medical Systems Corporation Paul Biggins
K182015 07/27/2018 Piccolo Composite« Plate System CarboFix Orthopedics Ltd. Yael Rubin
K182010 07/27/2018 ProgenaMatrix Cell Constructs I, LLC Elizabeth O'Keeffe
K181736 07/02/2018 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention (CDC) Yon Yu
K181736 07/02/2018 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention (CDC) Yon Yu
K181772 07/03/2018 NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) Ceterix Orthopaedics, Inc. Tarhan Kayihan
K181772 07/03/2018 NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) Ceterix Orthopaedics, Inc. Tarhan Kayihan
K181863 07/12/2018 Elvie Pump Chiaro Technology Limited Jonathan O'Toole
K181995 07/26/2018 Chiral Surgical Pedicle Screw System Chiral Surgical Andy Choi
K181963 07/23/2018 ostaPek Interbody Fusion Cages coLigne, AG Robert Lange
K181811 07/06/2018 ReTrace Ureteral Access Sheath Coloplast A/S Cori Ragan
K181757 07/02/2018 G?nther Tulip« Vena Cava Filter Retrieval Set Cook Incorporated Steven Lawrie
K181920 07/18/2018 Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker CooperVision, Inc. Marie Dutton
K181836 07/10/2018 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters Cordis, a Cardinal Health Company Vidya Venkataeaghavan
K181836 07/10/2018 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters Cordis, a Cardinal Health Company Vidya Venkataeaghavan
K181799 07/05/2018 ResCUBEÖ Ligament Fixation System Cousin Biotech S.A.S. Mathilde Collet
K181799 07/05/2018 ResCUBEÖ Ligament Fixation System Cousin Biotech S.A.S. Mathilde Collet
K182008 07/27/2018 Phasix ST Mesh with Echo 2 Positioning System CR Bard Inc. Shirin Mate
K181866 07/12/2018 MotoCLIP/HiMAX Step Staple Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K181866 07/12/2018 MotoCLIP/HiMAX Step Staple Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K181962 07/23/2018 CubeVue CurveBeam, LLC Stuti Singh
K181962 07/23/2018 CubeVue CurveBeam, LLC Stuti Singh
K182041 07/30/2018 Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom, Inc. Luke Olson
K181891 07/13/2018 Portable X-ray System (Model: MiniX-V, Mini X-S) Digimed Co., LTD. Youngbae Kwon
K181891 07/13/2018 Portable X-ray System (Model: MiniX-V, Mini X-S) Digimed Co., LTD. Youngbae Kwon
K181867 07/12/2018 Deka Smartxide2 Trio El.En Electronic Engineering Spa Paolo Peruzzi
K181941 07/20/2018 Swift System Emblation Ltd Mairi MacFadyen
K181861 07/12/2018 Embrace Empatica Srl Simone Tognetti
K181997 07/26/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K181997 07/26/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K182057 07/31/2018 EasyMax BT Self-Monitoring Blood Glucose System EPS Bio Technology Corp. Cynthia Hung
K182057 07/31/2018 EasyMax BT Self-Monitoring Blood Glucose System EPS Bio Technology Corp. Cynthia Hung
K181886 07/13/2018 VivaSight-DL System ETView Ltd. Yoram Levy
K181880 07/13/2018 VivaSight-SL (TVT) system ETView Ltd. Yoram Levy
K181849 07/11/2018 iStim S2 OTC Pain Relief TENS Everyway Medical Instruments CO., LDT. Paul Hung
K181849 07/11/2018 iStim S2 OTC Pain Relief TENS Everyway Medical Instruments CO., LDT. Paul Hung
K181794 07/05/2018 Truliant Porous Femoral Components Exactech, Inc. Patrick Hughes
K182051 07/31/2018 FUJIFILM Duodenoscope Model FUJIFILM Corporation Randy Vader
K181763 07/03/2018 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation Randy Vader
K181763 07/03/2018 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation Randy Vader
K181773 07/03/2018 Synapse 3D Optional Tools FUJIFILM Corporation Randy Vader
K181815 07/09/2018 DynaBridge Fusion Orthopedics, LLC Adam Cundiff
K181741 07/02/2018 IceSphere 1.5 CX Cryoablation Needle Galil Medical Ltd. Stacey Backlund
K181741 07/02/2018 IceSphere 1.5 CX Cryoablation Needle Galil Medical Ltd. Stacey Backlund
K182059 07/31/2018 Prase MIS Spinal System GBS Commonwealth Co., Ltd. Jimmy Kim
K181783 07/03/2018 LOGIQ P9; LOGIQ P7 GE Healthcare Bryan Behn
K181985 07/25/2018 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K181934 07/19/2018 Vivid T8, Vivid T9 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K181791 07/05/2018 SIMPLYSTRONG, SIMPLYEZEE Genicon, Inc Katlyn Kachman
K181791 07/05/2018 SIMPLYSTRONG, SIMPLYEZEE Genicon, Inc Katlyn Kachman
K181943 07/20/2018 OSCAR (OSCAR Prime, OSCAR Classic) Genoray Co., Ltd. Jeff Hwang
K181943 07/20/2018 OSCAR (OSCAR Prime, OSCAR Classic) Genoray Co., Ltd. Jeff Hwang
K182000 07/26/2018 AQrate Robotic Assistance System Globus Medical Inc. Kelly J. Baker
K181846 07/11/2018 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolu Globus Medical Inc. Lori Burns
K181855 07/11/2018 RadialSeal Introducer Kit Greatbatch Medical Phyllis Piet-Hughes
K181855 07/11/2018 RadialSeal Introducer Kit Greatbatch Medical Phyllis Piet-Hughes
K181790 07/05/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K181790 07/05/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K182035 07/30/2018 FFRct HeartFlow, Inc Windi Hary
K182043 07/30/2018 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Hebei Titans Hongsen Medical Technology Co., LTD. ShaoZhang Nan
K181751 07/02/2018 HemoCue Hb 801 System HemoCue AB Maria Fagerberg
K181974 07/24/2018 MyoSure XL Tissue Removal Device for Fluent Hologic, Inc Rachelle D. Fitzgerald
K181974 07/24/2018 MyoSure XL Tissue Removal Device for Fluent Hologic, Inc Rachelle D. Fitzgerald
K182006 07/27/2018 Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths Hologic, Inc Rachelle D. Fitzgerald
K181734 07/02/2018 Beurer IPL 8500 device/ IPL VelvetSkin Pro Home Well Trading LTD Martin Gurovich
K181874 07/13/2018 MX40 Mobile Digital X-ray System Huestis Machine Corporation Frederick M. Correira
K181939 07/19/2018 icobrain icometrix NV Jan Verheyden
K181868 07/12/2018 SHINY RPL System IDS, Ltd. C.J. Park
K181897 07/16/2018 Reprocessed Marinr Diagnostic EP Catheter Innovative Health, LLC. Amanda Babcock
K181902 07/16/2018 Codman Certas Plus Electronic Tool Kit Integra LifeSciences Corp. Nancy MacDonald
K181999 07/26/2018 Integra TITAN Reverse Shoulder System Integra Lifesciences Corporation Blesson Abraham
K181982 07/25/2018 MIDAScope and Introducer Kit, and MIDASystem IntraVu, Inc. Plamena Entcheva-Dimitrov
K181982 07/25/2018 MIDAScope and Introducer Kit, and MIDASystem IntraVu, Inc. Plamena Entcheva-Dimitrov
K181806 07/06/2018 ARIX Sternal System Jeil Medical Corporation Ahhyeon Woo
K181890 07/13/2018 Brainlab Compatible K2M Navigation Instruments K2M Nancy Giezen
K181878 07/13/2018 Kiierr 272 Laser, Kiierr 148 Laser Kiierr International, LLC Michael Anderson
K181749 07/02/2018 SuperCable« Iso-ElasticÖ Cerclage System Kinamed, Incorporated Heather Neely
K181749 07/02/2018 SuperCable« Iso-ElasticÖ Cerclage System Kinamed, Incorporated Heather Neely
K182002 07/26/2018 Cumulus Remover Kitazato Corporation Futoshi Inoue
K181750 07/02/2018 SITZMARKS Konsyl Pharmaceuticals Frank Gunsallus III
K181857 07/11/2018 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Kossan International Sdn. Bhd. Cho Sow Fong
K181895 07/16/2018 Kurin PIV Blood Collection Set with High Pressure Kurin, Inc Bob Rogers
K181958 07/23/2018 MagnetOs Putty Kuros Biosciences B.V. Yvonne P. Bovell
K182045 07/30/2018 Lotus III Multi-Pulsed Er: Yag Laser System Laseroptek Co., Ltd. Hong Chu
K181775 07/03/2018 Quantum Blood and IV Fluid Infusion Warmer Life Warmer, Inc. John Pettini
K181889 07/13/2018 MTS Penicillin 0.002- 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K181956 07/23/2018 Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation Kelly Nguyen
K181826 07/09/2018 Glenoid Polyaxial Non-locking Screws Medacta International SA Stefano Baj
K181970 07/24/2018 MectaLIF Posterior Extension Medacta International SA Stefano Baj
K181803 07/05/2018 Medax Biopsy Systems III Medax Srl Unipersonale Stefano Cavalieri
K181789 07/05/2018 VeriSuite MedCom GmbH Johannes Messow
K181937 07/19/2018 Pump In Style Advanced, Advanced Personal Double Breastpump Medela LLC PJ Pasia
K181820 07/09/2018 Medline Unite Mini Plates and Screws Medline Industries, Inc. Jennifer Mason
K181809 07/06/2018 GRYPHON« Anchors with DYNACORDÖ Suture Medos International SARL Tatyana Korsunsky
K181809 07/06/2018 GRYPHON« Anchors with DYNACORDÖ Suture Medos International SARL Tatyana Korsunsky
K181949 07/20/2018 SYMPHONYÖ OCT System Medos International SARL Sheree Geller
K181781 07/03/2018 DynaClipTM Bone Staple MedShape, Inc. Jack Griffis
K181954 07/23/2018 autoLog IQ Autotransfusion System MEDTRONIC PERFUSION SYSTEMS Sue Fidler
K181954 07/23/2018 autoLog IQ Autotransfusion System MEDTRONIC PERFUSION SYSTEMS Sue Fidler
K181918 07/18/2018 CardioInsight Cardiac Mapping System Medtronic, Inc. Janell Colley
K181973 07/24/2018 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K181973 07/24/2018 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K181978 07/24/2018 ZeniusÖ, IliadÖ and KoraÖ Spinal Fixation Systems Medyssey USA, Inc. Shawn Kim
K181978 07/24/2018 ZeniusÖ, IliadÖ and KoraÖ Spinal Fixation Systems Medyssey USA, Inc. Shawn Kim
DEN180040 07/30/2018 Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit Meridian Bioscience, Inc. Jack Rogers
K181819 07/09/2018 SMARTRELEASE Endoscopic Soft Tissue Release System MicroAire Surgical Instruments LLC Glenn Gerstenfeld
K181883 07/13/2018 FIREFLY« Midline Navigation Guide Mighty Oak Medical Inc. Mark A. Wylie
K182016 07/27/2018 Simplicit90Y Mirada Medical Ltd. Sarah Bond
K182036 07/30/2018 NeuroBlate System Monteris Medical David H. Mueller
K181869 07/12/2018 On1 Universal Abutment Nobel Biocare AB Charlemagne Chua
K181917 07/17/2018 MTA2.3 MATERIALS NuSmile, LTD. Alafiz Prasla
K181860 07/12/2018 NuVasive Cohere Thoracolumbar Interbody System NuVasive, Incorporated Olga Lewis
K181991 07/26/2018 NxStage Connected Health System NxStage Medical, Inc Christina Marabella
K181994 07/26/2018 Single Use Aspiration Needle NA-U201H Olympus Medical Systems Corp. Toshiyuki Nakajima
K181992 07/26/2018 Heat Pain Pro Omron Healthcare, Inc. Renee Thornborough
K181936 07/19/2018 DyeVert PLUS EZ Contrast Reduction System Osprey Medical, Inc. Vic Fabano
K181977 07/24/2018 WiScope Digital Endoscope System OTU Medical Inc. Doris Dong
K181977 07/24/2018 WiScope Digital Endoscope System OTU Medical Inc. Doris Dong
K181975 07/24/2018 Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30?g) MEV30 Oxoid Limited (Part of Thermo Fisher Scientific) Philip Brame
K182004 07/27/2018 PENTAX Medical Endoscopic Ultrasound System PENTAX of America, Inc. William Goeller
K182004 07/27/2018 PENTAX Medical Endoscopic Ultrasound System PENTAX of America, Inc. William Goeller
K181945 07/20/2018 QuickScreen Pro Multi Drug Screening Test, Model 9395Z Phamatech Inc. Robert Merlock
K181830 07/09/2018 Azurion R2.0 Philips Medical Systems Nederland BV Owen Callaghan
K181830 07/09/2018 Azurion R2.0 Philips Medical Systems Nederland BV Owen Callaghan
K181966 07/23/2018 SmartPerfusion Philips Medical Systems Nederlands B.V. Chandrika Srinivasan
K181966 07/23/2018 SmartPerfusion Philips Medical Systems Nederlands B.V. Chandrika Srinivasan
K181831 07/09/2018 IntelliVue Multi-Measurement Module MMX Philips Medizin Systeme Boeblingen GmbH Stefan Breuer
K181797 07/05/2018 Philips CT Big Bore Sliding Gantry Configuration Phillips Medical Systems (Cleveland) Inc. Michael Chilbert
K181797 07/05/2018 Philips CT Big Bore Sliding Gantry Configuration Phillips Medical Systems (Cleveland) Inc. Michael Chilbert
K181825 07/09/2018 CAAS MR Solutions Pie Medical Imaging B.V. Annemiek Bouts
K181904 07/16/2018 5 FR Dual Lumen Piper PICC Piper Access LLC Jay Muse
K181983 07/25/2018 PreXion 3D Excelsior PreXion Corporation Katsumi Hayashi
K181983 07/25/2018 PreXion 3D Excelsior PreXion Corporation Katsumi Hayashi
K181816 07/09/2018 Ceramic Denture Zirconia Ceramics Block Qinhuangdao Silide Ceramic Technology Co., Ltd Lou ChunHua
K182042 07/30/2018 Randox Calcium (Ca) Randox Laboratories Ltd. Pauline Armstrong
K181948 07/20/2018 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil RAPID Biomedical GmbH Christian Zimmermann
K182007 07/27/2018 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System Renovis Surgical Technologies Anthony DeBenedictis
K181771 07/03/2018 RightEye Vision System RightEye, LLC Adam Gross
K181968 07/24/2018 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech(Hangzhou)Co.,Ltd. Alex Qiu
K181968 07/24/2018 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech(Hangzhou)Co.,Ltd. Alex Qiu
K181998 07/26/2018 CardioBand ECG Event Recorder Samsung Semiconductor Inc. Bhupinder Singh
K181828 07/09/2018 Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile Scientia Vascular LLC David Sabodski
K181828 07/09/2018 Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile Scientia Vascular LLC David Sabodski
K182001 07/26/2018 Acucy Influenza A&B Test with the Acucy System Sekisui Diagnostics, LLC Shelly Harris
K181744 07/02/2018 BI-MENTUM dual mobility system Serf Jean-Lus Aurelle
K182018 07/27/2018 Bluetooth blood pressure monitor Shenzhen Kingyield Technology Co., Ltd. Dacheng Gong
K181967 07/23/2018 Disposable Temperature Probe Shenzhen Launch Electrical Co., LTD Jiaan Huang
K181795 07/05/2018 AST Model MA012 and MS019 Rehab Wheelchair Sichuan AST Medical Equipment Co., Ltd. Johnson Van
K181767 07/03/2018 Cios Select Siemens Medical Solutions USA, Inc. Patricia D. Jones
K181767 07/03/2018 Cios Select Siemens Medical Solutions USA, Inc. Patricia D. Jones
K182050 07/31/2018 Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch Siemens Medical Solutions USA, Inc. Martin Rajchel
K181881 07/13/2018 Outlet Sacroiliac Joint Fusion System SIJ Surgical Daniel Hoehn
K181899 07/16/2018 ROCCIA« PLIF Silony Medical GmbH Bircan Tasdelen
K181759 07/02/2018 PowerDot PD-01MT Smartmissimo Technologies Pte Ltd Alexey Pisarev
K181746 07/02/2018 MICRORAPTOR Knotless Suture Anchor Smith and Nephew, Inc. Katherine Marcaccio
K181922 07/18/2018 Sonendo Material A Sonendo, Inc. Eric Simon
K181850 07/11/2018 Inversa Implants Southern Implants (Pty) Ltd Lauranda Breytenbach
K181942 07/20/2018 Quantum Ventilation Module Spectrum Medical Ltd Mark Drain
K181923 07/18/2018 Quantum Workstation 12.1 Spectrum Medical Ltd Colleen Powell
K181923 07/18/2018 Quantum Workstation 12.1 Spectrum Medical Ltd Colleen Powell
K181837 07/10/2018 Spinal Elements Ti-Bond coated devices Spinal Elements Inc. Julie Lamothe
K181818 07/09/2018 Scarlet AL-T Spineart Franck Pennesi
K181792 07/05/2018 DuoÖ Lumbar Interbody Fusion Device Spineology Inc. Karen Roche
K181792 07/05/2018 DuoÖ Lumbar Interbody Fusion Device Spineology Inc. Karen Roche
K181865 07/12/2018 Acu-sInQ Complete Endoscope Cleaning Aid System STERIS Corporation Gregory Land
K181752 07/02/2018 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation Kristi Ashton
K181848 07/11/2018 ADAPT for Gamma3, Gamma3 Stryker GMBH Tina Mornak
K181742 07/02/2018 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Stryker GmbH Tina Mornak
K181774 07/03/2018 Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture Teleflex Medical Incorporated Andrea Curria
K181852 07/11/2018 Percuvance Percutaneous Surgical System Teleflex Medical, Inc. Kim Campbell
K181946 07/20/2018 Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific Cynthia Knapp
K181946 07/20/2018 Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific Cynthia Knapp
K182025 07/30/2018 ClearUP Sinus Pain Relief Tivic Health Systems Inc. Nina Peled
K182027 07/30/2018 Wet Organics Personal Lubricant Trigg Laboratories DBA Wet International Simone Buntin
K181898 07/16/2018 Two-Step Implant System Trilliant Surgical Jon Olson
K182046 07/31/2018 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System Tyson Bioresearch, Inc. Vance Chang
K182047 07/31/2018 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System Tyson Bioresearch, Inc. Vance Chang
K181824 07/09/2018 CBT Screw Fixation System U&i Corporation Jee-Ae Bang
K182055 07/31/2018 SECULOKÖ ACP System U&i Corporation Kwang-Eun Song
K181829 07/09/2018 Velofix TLIF Cage U&I Corporation Jee-Ae Bang
K181921 07/18/2018 Solidity Vertebral Body Replacement ulrich medical USA Hans Stover
K181909 07/17/2018 Luminelle DTx Hysteroscopy System UVision360 Inc. Allison London Brown
K181909 07/17/2018 Luminelle DTx Hysteroscopy System UVision360 Inc. Allison London Brown
K181784 07/03/2018 Spectra S3 Plus Uzinmedicare Co. Nathan Ahn
K181903 07/16/2018 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device Varian Medical Systems, Inc. Peter J. Coronado
K181885 07/13/2018 Voyant System Viseon, Inc. Cora Sim
K181964 07/23/2018 JiveX Visus Health IT GmbH Axel Schreiber
K181877 07/13/2018 Phoenix 2.4mm Atherectomy Plus System Volcano AtheroMed Inc. Jean Chang
K181940 07/19/2018 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement W. L. Gore & Associates, Inc. Michael J. Titus
K181940 07/19/2018 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement W. L. Gore & Associates, Inc. Michael J. Titus
K181893 07/13/2018 T-PLUS Wintecare SA Claudio Freti
K181805 07/06/2018 UV Phototherapy Xuzhou Kernel Medical Equipment Co., LTD. Jing Wang
K182038 07/30/2018 URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer YD Diagnostics Corporation Hyuckjoo Lee
K181740 07/02/2018 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Ewald Riechert
K181740 07/02/2018 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Ewald Riechert
K181996 07/26/2018 MATRx Plus Zephyr Sleep Technologies Sabina Bruehlmann
K181827 07/09/2018 Affixus Natural Nail System Humeral Nail Zimmer GmbH Robert Tommasini
K181947 07/20/2018 Persona Revision Knee System Zimmer Inc. Nicole Meredith
K182048 07/31/2018 Avenir Complete Hip System Zimmer, Inc Rebecca D Noftz
K181761 07/03/2018 Zimmer Biomet Select Ceramic Heads Zimmer, Inc Carol Vierling
K181892 07/13/2018 Ziostation2 Ziosoft, Inc. Tsuyoshi Nagata


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