FDA 510(k) Decisions During September, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K181748 09/12/2018 Magnesium Abbott Laboratories Mark Littlefield
K181563 09/26/2018 The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology Access Scientific, LLC Martina Nguyen
K182243 09/18/2018 The CVC WAND Safety Introducer with Valved Peelable Sheath Access Scientific, LLC Martina Nguyen
K181124 09/28/2018 Acessa ProVu System Acessa Health, Inc. Brian J. Bergeron
K182226 09/11/2018 AirStrip RPM InvisionHeart Adapter AirStrip Technologies, Inc. Kirk Johnson
K182053 09/07/2018 UltravisionÖ Visual Field Clearing System Alesi Surgical Ltd. David Broderick
K181980 09/25/2018 OsseoScrew System Alphatec Spine, Inc. Jeremy Markovich
K181277 09/28/2018 E-CUBE 12 Alpinion Medical Systems Co., Ltd. Boyeon Cho
K181423 09/07/2018 AMSure Sterile Water, and Sterile Normal Saline for Wound Flush Amsino International Inc. Jane Gao
K181814 09/04/2018 AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water Amsino International, Inc. Cathy Hong
K182147 09/07/2018 CTXX85 Analogic Corporation Karen Provencher
K181926 09/21/2018 InVivo Web Viewer Anatomage Inc. Changxin Xu
DEN180044 09/11/2018 ECG App Apple Inc Donna-Bea Tillman
DEN180042 09/11/2018 Irregular Rhythm Notification Feature Apple Inc Donna-Bea Tillman
K180041 09/28/2018 BioCode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc. Robert Di Tullio
K182039 09/28/2018 Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay Arthrex Inc. Courtney Smith
K181769 09/21/2018 Arthrex FiberTak Suture Anchor Arthrex, Inc. David L. Rogers
K181665 09/21/2018 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN Becton,Dickinson and Company Monica E. Giguere
K181821 09/13/2018 MOSS VRS Spinal System Biedermann Motech GmbH & Co. KG Gerd Federle
K181006 09/21/2018 BB-613 Watch Oximeter Bio-Beat Technologies Ltd. Johanan May
K181337 09/18/2018 Sypher Spacer System Biogennix, LLC Tim Bumbalough
K180998 09/28/2018 BioHorizons CAD/CAM Bars BioHorizons Implant Systems, Inc. Michael Davis
K181611 09/24/2018 Comprehensive Reverse Shoulder System Biomet Manufacturing Corp Dalene Binkley
K181021 09/27/2018 EmboCube Embolization Gelatin Biosphere Medical, S.A. Alix Fonlladosa
K180068 09/28/2018 ORISE Gel Boston Scientific Thomas Hirte
K180144 09/21/2018 Agile Esophageal Stent System Boston Scientific Corporation Kayla Mackey
K182315 09/26/2018 Magic Torque DLVR Guidewire Boston Scientific Corporation Andrea Dance
K182275 09/13/2018 Seal Single Use Biopsy Valve Boston Scientific Corporation Andrew Akers
K180781 09/19/2018 Bard Vertus Foley Catheter C. R. Bard, Inc. Sharon Lambert
K181466 09/01/2018 Cadwell Zenith System Cadwell Industries, Inc. Alison Hull
K181466 09/01/2018 Cadwell Zenith System Cadwell Industries, Inc. Alison Hull
K182415 09/28/2018 Alphenix, INFX-8000F/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181415 09/10/2018 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 Canon Medical Systems Corporation Paul Biggins
K182223 09/14/2018 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A Canon Medical Systems USA Paul Biggins
K181229 09/19/2018 TirboLOX-C Cervical IBFD Captiva Spine, Inc. Jackie Ferro
K182377 09/27/2018 CarboClear« Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K181205 09/20/2018 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention Yon Yu
K181995 09/20/2018 Chiral Surgical Pedicle Screw System Chiral Surgical Andy Choi
K181811 09/07/2018 ReTrace Ureteral Access Sheath Coloplast A/S Cori Ragan
K181128 09/06/2018 Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) Contego Medical, LLC Elizabeth Saylors
K180182 09/14/2018 Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter Cook Incorporated Samuel Engelman
K180029 09/21/2018 Malecot Nephrostomy Catheter/Stent Set Cook Incorporated Minjin Choi
K180216 09/28/2018 Seidmon Antegrade AQ Stent Set Cook Incorporated Rebecca Odulio (Li-Chun-Liu)
K180053 09/13/2018 Sof-Flex Ureteral Stent Set Cook Incorporated Minjin Choi
K181061 09/07/2018 Corin Optimized Positioning System (OPS) Femoral Corin USA Lucinda Gerber
K181721 09/17/2018 Ceracell Ortho Foam curasan AG Gregor Thomas
K181476 09/28/2018 Prime&Bond active Universal Adhesive Dentsply Sirona Karl Nittinger
K182214 09/14/2018 DizzyDoctor System 1.0.0 DizzyDoctor Systems, LLC Ian Purcell
K181066 09/26/2018 Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims ECO Medi Glove Sdn Bhd Suresh Kumar
K181510 09/04/2018 ECHOLASER X4 El.En Electronic Engineering Spa Paolo Peruzzi
K182138 09/05/2018 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD Eleckta Limited Andrew Hedges
K181653 09/18/2018 Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed Ethicon Endo-Surgery, LLC Sigfrido Delgado
K181652 09/28/2018 Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture Ethicon, Inc. Donna Marshall
K181707 09/26/2018 Everyway Wireless TENS & EMS Unit Everyway Medical Instruments Co., Ltd. Paul Hung
K181532 09/04/2018 Exactech Alteon Monobloc Revision Stem Exactech, Inc. Zach Sharrah
K181794 09/28/2018 Truliant Porous Femoral Components Exactech, Inc. Patrick Hughes
K181620 09/18/2018 Endoscopic Linear Cutting Staplers and Loading Units for Single Use Ezisurg (Suzhou) Medical Co., Ltd. Renjing Tian
K181773 09/25/2018 Synapse 3D Optional Tools FUJIFILM Corporation Randy Vader
K181783 09/20/2018 LOGIQ P9; LOGIQ P7 GE Healthcare Bryan Behn
K182234 09/06/2018 Optima XR240amx GE Medical Systems, LLC Chris Paulik
K181558 09/06/2018 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
K181034 09/21/2018 Pocket Colposcope System Hadleigh Health Technologies, LLC Robert Miros
K182357 09/26/2018 HardyDisk AST Eravacycline 20?g (ERV20) Hardy Diagnostics Anna Klavins
K181692 09/25/2018 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
K182043 09/21/2018 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Hebei Titans Hongsen Medical Technology Co., LTD. ShaoZhang Nan
K181594 09/13/2018 Spectralis HRA+OCT and variants with OCT Angiography Module Heidelberg Engineering GmbH Christoph Schoess
K182260 09/17/2018 PALACOS MV Heraeus Medical GmbH Ute Greiner
K181734 09/19/2018 Beurer IPL 8500 device/ IPL VelvetSkin Pro Home Well Trading LTD Martin Gurovich
K181874 09/14/2018 MX40 Mobile Digital X-ray System Huestis Machine Corporation Frederick M. Correira
K182196 09/11/2018 Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth Imediplus, Inc. Moriah Hsieh
K182402 09/27/2018 CoLink View Plating System In2Bones USA, LLC Christine Scifert
K182325 09/26/2018 InMode RF System Inmode MD Ltd. Amit Goren
K181397 09/27/2018 DualX Innovasive, Inc. Andy Choi
K180964 09/28/2018 Endoscope Sterilization Tray Intuitive Surgical, Inc. Kunal Gunjal
K181662 09/05/2018 Iridex TruFocus LIO Premiere Iridex Corporation Edward J. Sinclair
K180714 09/24/2018 Probe Covers for Thermometers K-jump Health Co., Ltd. JM Lin
K181199 09/20/2018 Katalyst Mark 1 Muscle Stimulation System Model 2 Katalyst Inc. Bjoern Woltermann
K181878 09/05/2018 Kiierr 272 Laser, Kiierr 148 Laser Kiierr International, LLC Michael Anderson
K181241 09/13/2018 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K182153 09/06/2018 Ultrasound System SONIMAGE HS1 KONICA MINOLTA, INC. Tsutomu Fukui
K181380 09/11/2018 LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd. Jihyeon Seo
K181537 09/07/2018 GLOW800 Leica Microsystems (Schweiz) AG Georges Hakim
K180894 09/19/2018 Magnetic Surgical System Levita Magnetics International Corp. Alberto Rodrigues-Navarro
K181167 09/02/2018 Upcera Glaze Paste, Glaze Powder, and Glaze Liquid Liaoning Upcera Co., Ltd Charles Shen
K181167 09/02/2018 Upcera Glaze Paste, Glaze Powder, and Glaze Liquid Liaoning Upcera Co., Ltd Charles Shen
K180215 09/13/2018 DYNA-LINK ELITE Stand-Alone Anterior Lumbar System Life Spine Inc. Randy Lewis
K181889 09/13/2018 MTS Penicillin 0.002- 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K180973 09/28/2018 Libertas Hip Replacement System Maxx Orthopedics, Inc Corey Perine
K181789 09/21/2018 VeriSuite MedCom GmbH Johannes Messow
K181591 09/26/2018 Fixated Asfora BULLET CAGE« (FABC) Medical Designs, LLC Kristi Vondra
K181568 09/11/2018 IPL Salon Hair Reduction System Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt Bruce Wu
K181726 09/20/2018 Medline Patient Cables and Lead Wires Medline Industries, Inc. Dinah Rincones
K182079 09/07/2018 Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask MEDTEC Inc. dba CIVCO Medical Solutions Alena Newgren
K180933 09/17/2018 DenTek Ultimate Dental Guard Medtech Products Inc. Mary Beth Fritz
K180875 09/14/2018 POLY REJUV Medtek Skincare, LLC Gary Richardson
K181328 09/19/2018 T2 STRATOSPHEREÖ Expandable Corpectomy System Medtronic Sofamor Danek, USA Inc. Kanesha Hines
K182335 09/25/2018 CPX 4 Breast Tissue Expander with Smooth Surface Mentor Worldwide LLC Martin Sprunck
K182290 09/25/2018 IBM iConnect Access Merge Healthcare Incorporated Tracey Fox
K181200 09/21/2018 AEROmini Tracheobronchial Stent System Merit Medical Systems, Inc David Thomas
K180871 09/14/2018 Portable Nebulizer MicroBase Technology Corporation Molly Hsieh
K181598 09/14/2018 Prime E-CLASS XLPE Liner MicroPort Orthopedics Inc. Sarah Evonne Stroupe
K180366 09/20/2018 EndoTool SubQ Monarch Medical Technologies, Inc. Linda Beneze
K180778 09/07/2018 Exceed Microneedling Device MT.DERM GmbH Anderas Pachten
K182263 09/07/2018 RetCam 3 ; RetCam Shuttle ; RetCam Portable Natus Medical Incorporated Brian R. Ackley
K181078 09/10/2018 The Sex Gel Necessaire, Inc. Randi Christiansen Stanley
K181702 09/21/2018 Tranquil-L Interbody System Nexus Spine, LLC Jared Crocker
K182340 09/20/2018 NICO Myriad NICO Corporation Sean Spence
K181075 09/27/2018 PureSet Tray Nobel Biocare AB Charlemagne Chua
K180340 09/26/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K181991 09/26/2018 NxStage Connected Health System NxStage Medical, Inc Christina Marabella
K182317 09/24/2018 AMADEO M-DR mini, AMADEO M-AX mini OEHM UND REHBEIN GMBH Markus Brueggmann
K181270 09/07/2018 Disposable SpO2 Sensors, Reusable SpO2 Sensors Orantech Inc. Yunxi Xiong
K180241 09/28/2018 Orthocaps Twinaligner Ortho Caps GmbH Wajeeh Khan
K181390 09/18/2018 Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System OrthoPediatrics, Corp Mark Fox
K181449 09/19/2018 Ortoma Treatment Solution - OTS Ortoma AB Linus Bystrom
K182286 09/19/2018 Oh'Care Lite Smart Blood Glucose Monitoring System OSANG Healthcare Co., Ltd. Jin Ho An
K181236 09/13/2018 HySil Impression Materials OSSTEM IMPLANT CO LTD Jungmin Yoo
K181975 09/27/2018 Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30?g) MEV30 Oxoid Limited (Part of Thermo Fisher Scientific) Philip Brame
K182148 09/07/2018 SILVERBACK Gorilla Plating System Paragon 28, Inc. Eric Lintula
K181616 09/21/2018 PSM 3-Way Silicone Foley Catheter Pathway, LLC David Stroup
K181424 09/25/2018 PeDIA PeDIA, LLC Diane Miller
K181102 09/15/2018 ThermaCare Quick Therapy TENS Pfizer Inc. Nicola Romano
K181311 09/07/2018 Philips Hemodynamic Application R1.0 Philips Medical Systems Nederlands B.V. Owen Callaghan
K181314 09/04/2018 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension Philips Medizin Systeme Boeblingen GmbH Stefan Breuer
K181904 09/25/2018 5 FR Dual Lumen Piper PICC Piper Access LLC Jay Muse
K181576 09/13/2018 Planmeca Viso Planmeca Oy Lars Moring
K181305 09/20/2018 OralTox Oral fluid Drug Test Premier Biotech, Inc. Jacqueline Gale
K182157 09/18/2018 BioSign Flu A+B Princeton BioMeditech Corp. Kyung-ah Kim
K182144 09/07/2018 Bi-Flex Evo Promepla Sam Alexandre Bareille
K181455 09/10/2018 ProSun sunlamp products, Luxura sunlamp products ProSun International LLC Tom Henkemans
K180893 09/19/2018 IHM Technology Bandage Protege Biomedical Mike Corcoran
K181000 09/13/2018 SelectFlex 072 Neurovascular Access System Q'Apel Ken Peartree
K182213 09/14/2018 QT Ultrasound Breast Scanner - 1 QT Ultrasound LLC Mark W. Lenox
K181632 09/17/2018 Venacure 1470 Pro Quanta System Spa Francesco Dell'Antonio
K180369 09/14/2018 Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) Relievant Medsystems Alex DiNello
K181655 09/11/2018 Renovis S180 Lateral Lumbar Interbody Fusion System Renovis Surgical Technologies Anthony Debenedictis
K181320 09/18/2018 Caprolon Resorba Medical GmbH Helen Topping
K181771 09/28/2018 RightEye Vision System RightEye, LLC Adam Gross
K181233 09/18/2018 Elecsys FT4 III Roche Diagnostics Reanna Toney
K182370 09/27/2018 Acculoc Total Knee System RootLoc Co., Ltd. Jungsun Ha
K181518 09/06/2018 Sebacia Microparticles Sebacia, Inc. Todd J. Meyer
K180177 09/13/2018 Guidewire Shanghai Kindly Medical Instruments Co., Ltd. Xu Jianhai
K180178 09/10/2018 Introducer Set Shanghai Kindly Medical Instruments Co., Ltd. Xu Jianhai
K181688 09/07/2018 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang
K180803 09/26/2018 BeautiBond Universal Shofu Dental Corporation Mauro Malzyner
K181795 09/25/2018 AST Model MA012 and MS019 Rehab Wheelchair Sichuan AST Medical Equipment Co., Ltd. Johnson Van
K181525 09/07/2018 INNOVANCE Free PS Ag Siemens Healthcare Diagnostics Products GmbH Petra Dissmann
K182208 09/07/2018 syngo.via View&GO (Version VA10A) Siemens Healthcare GmbH Elango Alampalayam Rangappan
K181366 09/24/2018 REDAPT Porous Acetabular Shell Smith & Nephew, Inc. Bryan Cowell
K181746 09/28/2018 MICRORAPTOR Knotless Suture Anchor Smith and Nephew, Inc. Katherine Marcaccio
K180465 09/06/2018 Provata Implant System Southern Implants (Pty) Ltd Lauranda G. Breytenbach
K180728 09/06/2018 Spinal Elements Cerclage System Spinal Elements Inc Julie Lamothe
K182345 09/21/2018 Spineology Navigation Instruments Spineology Inc Karen Roche
K181608 09/27/2018 Disposable Standard Clamp Standard Bariatrics Alison Sathe
K181249 09/04/2018 EUSRA RF Electrode STARmed Co., Ltd. Jun-Young Jung
K180981 09/19/2018 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit Stimwave Technologies Incorporated Elizabeth Greene
K181504 09/11/2018 Stryker Pediatric Mandibular Distractor 2 Stryker Gregory Gohl
K181742 09/27/2018 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Stryker GmbH Tina Mornak
K180916 09/24/2018 iNtuition-T1 Mapping and T2/T2* Mapping TeraRecon Inc., Megha Jain
K180489 09/21/2018 TEVADAPTOR Closed Drug Reconstitution and Transfer System Teva Medical Ltd., Migada Plant Nadav Reuben
K182376 09/28/2018 Harmony Topcon Medical Systems, Inc. James Lorkowski
K181420 09/20/2018 Aequalis Flex Revive Shoulder System Tornier, Inc. Laurie Lewandowski
K181088 09/28/2018 TSP Crosser Transseptal Access System Transseptal Solutions Ltd. Mary P. LeGraw
K182206 09/13/2018 RiX70 DC Trident s.r.l Giorgio Rizzo
K182055 09/10/2018 SECULOKÖ ACP System U&i Corporation Kwang-Eun Song
K181211 09/10/2018 Human Tecar HCR 1002 UNIBELL S.r.l Mario Scerri
K182258 09/21/2018 AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm United States Endoscopy Group, Inc. Carroll L. Martin
K182232 09/11/2018 Octane Mechanical Thrombectomy System Vascular Solutions, Inc. Iroquois Ledbeter
K181349 09/19/2018 Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens Visco Vision Inc Evan Huang
K182230 09/07/2018 Multi Modality Viewer Vital Images, Inc. Fei Li
K182310 09/21/2018 Volpara Imaging Software Volpara Health Technologies Limited Ralph Highnam
K180338 09/21/2018 Cellulize Ward Photonics LLC Terry Ward
K181255 09/12/2018 PRODENSE Bone Graft Substitute Wright Medical Technology, Inc. Rachel Roberts
K182080 09/19/2018 Scope Antifogging System Xodus Medical, Inc. Paul Lloyd


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