FDA 510(k) Applications Received During August, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K182243 08/20/2018 The CVC WAND Safety Introducer with Valved Peelable Sheath Access Scientific, LLC Martina Nguyen
K182226 08/16/2018 AirStrip RPM InvisionHeart Adapter AirStrip Technologies, Inc. Kirk Johnson
K182312 08/27/2018 Zyppah Anti-Snoring Device Always More Marketing Jonathan Greenburg
K182083 08/02/2018 Catalys Precision Laser System AMO Manufacturing USA, LLC James Patrick Garvey II
K182147 08/08/2018 CTXX85 Analogic Corporation Karen Provencher
K182090 08/02/2018 AposTherapy System APOS Medical Assets Ltd. Cliff Bleustein
DEN180044 08/14/2018 ECG App Apple Inc Donna-Bea Tillman
DEN180042 08/09/2018 Irregular Rhythm Notification Feature Apple Inc Donna-Bea Tillman
K182244 08/20/2018 Voyant Electrosurgical Generator Applied Medical Resources Corp. Andrew Nguyen
K182280 08/22/2018 ARK Tramadol Assay ARK Diagnostics, Inc. Cherry Mun
K182361 08/30/2018 Arthrex Compression FT Screws Arthrex Inc. Rebecca R. Homan
K182248 08/20/2018 Aspire Venting Tube Aspire Bariatrics, Inc Monica Ferrante
K182239 08/20/2018 OLYMPIC Posterior Spinal Fixation System Astura Medical, LLC Parker Kelch
K182255 08/20/2018 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) Aziyo Biologics, Inc. Wendy Perreault
K182337 08/28/2018 HYBRID Guidewire Balt USA, LLC Nancy Xu
K182249 08/20/2018 Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens Bausch & Lomb Incorporated Barbara Klube-Falso
K182276 08/22/2018 MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit Bayer Medical Care Inc. Katie Dillon
K182273 08/22/2018 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Bayer Medical Care Inc. Lisa A. Ewing
K182320 08/27/2018 BD Contoured Base Pen Needle Becton, Dickinson and Company Meriam Youssef
K182193 08/14/2018 S-Line BIO CETEC CO., LTD. Hee See JIN
K182270 08/22/2018 Cellene CO2 Laser System Bio-Med USA Inc. Young Chi
K182070 08/01/2018 BioHorizons Tapered IM Implants BioHorizons Implant Systems, Inc. Michael Davis
K182283 08/23/2018 FUSE Pedicle Screw System Black Box Medical Todd Stanaford
K182065 08/01/2018 EVOLUX CAD/CAM PMMA BLOCKS Blue Dent Dental Adriana Paula T I Gomes
K182338 08/28/2018 Blue Sky Bio Computerized Orthodontic Bracket System Blue Sky Bio Albert Zickmann
K182169 08/10/2018 AdVance XP Male Sling Boston Scientific Corporation Kaitlyn Rainbow
K182315 08/27/2018 Magic Torque DLVR Guidewire Boston Scientific Corporation Andrea Dance
K182275 08/22/2018 Seal Single Use Biopsy Valve Boston Scientific Corporation Andrew Akers
K182324 08/27/2018 EkoSonic MACH 4 Endovascular Device with EkoSonic Control Unit BTG International, Inc. Benjamin Hornsey
K182106 08/03/2018 BTL 799-2T BTL Industries, Inc. David Chmel
K182363 08/30/2018 BTL-703 BTL Industries, Inc. David Chmel
K182281 08/23/2018 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech C.R. Bard Sari Stevens
K182282 08/23/2018 Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation Paul Biggins
K182223 08/16/2018 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A Canon Medical Systems USA Paul Biggins
K182377 08/31/2018 CarboClear« Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K182318 08/27/2018 Retina Workplace Carl Zeiss Meditec, Inc Maria Golovina
K182149 08/08/2018 FFRangio System CathWorks Ltd Miriam Ivenshitz
K182306 08/24/2018 Sunkingdom Slit Lamp Chongqing Sunkingdom Medical Instrument Co Ltd Joy Tse
K182067 08/01/2018 PleuraFlow System with FlowGlide Extra Drainage Length ClearFlow, Inc. Dov Gal
K182067 08/01/2018 PleuraFlow System with FlowGlide Extra Drainage Length ClearFlow, Inc. Dov Gal
K182339 08/28/2018 LEUCADIA AUTOLOKÖ Pedicle Screw System ClearView Orthopedic Development, LLC Hartmut Loch
K182116 08/06/2018 BA310 Abutment, BIA310 Implant/Abutment Cochlear Americas Beth Murray
K182122 08/06/2018 Ureteric Catheters Coloplast Corp Cori Ragan
K182202 08/14/2018 SLEEPAPP Comfort Acrylics, Inc. Richard W. Moore
K182134 08/06/2018 ARiX RAD Radiographic System Compania Mexicana De Radiologia CGR, S.A. DE C.V. Tonatiuh Monroy Soberon
K182304 08/24/2018 Hyper GP (tisilfocon A) Daily Wear Contact Lens CONTAMAC LTD. Rob McGregor
K182066 08/01/2018 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set Cook Incorporated Carly Powell
K182199 08/14/2018 NFC-700 non-mydriatic auto fundus camera Crystalvue Medical Corporation Oliver Lin
K182151 08/08/2018 MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate CTL Medical Corporation Andrea Wilcox
K182220 08/15/2018 Curbell branded Patient Monitoring Cables Curbell Medical Products, Inc. Michael Winter
K182365 08/30/2018 TempSure System Cynosure, Inc Amy Tannenbaum
K182215 08/15/2018 ClearLink Controlled Phototherapy Equipment Daavlin Distributing Company Michele Thiel
K182288 08/23/2018 TPH Spectra ST Flowable Composite Restorative Dentsply Sirona Karl Nittinger
K182150 08/08/2018 Devon 52 Sequential Compression Device Devon Medical Products (Jiangsu) Ltd Neil Cheng
K182329 08/28/2018 SureCure Orthodontic Aligner System Digital Orthodontic Care Jeff Sheppard
K182194 08/14/2018 UV Active Implant System DIO Corporation Park Jiae
K182214 08/15/2018 DizzyDoctor System 1.0.0 DizzyDoctor Systems, LLC Ian Purcell
K182245 08/20/2018 EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System Edwards Lifesciences, LLC Christine Chun
K182138 08/07/2018 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD Eleckta Limited Andrew Hedges
K182369 08/31/2018 gammaCore Sapphire Electrocore, Inc. Mike Romaniw
K182076 08/01/2018 Elekta Unity Elekta Limited Nicholas Power
K182107 08/03/2018 CarriGen PF ETEX Corporation Stacy Hutchens
K182107 08/03/2018 CarriGen PF ETEX Corporation Stacy Hutchens
K182346 08/28/2018 TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws Exactech, Inc. Meredith May
K182087 08/02/2018 DynaMesh-POSTERIOR FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft Stefan Schneemelcher
K182088 08/02/2018 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro Fotona d.o.o. Marko Berdajs
K182367 08/31/2018 DIASAFEplusUS Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K182277 08/22/2018 Versana Premier GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K182234 08/17/2018 Optima XR240amx GE Medical Systems, LLC Chris Paulik
K182212 08/15/2018 Geo Staple System Gramercy Extremity Orthopedics, LLC Michael P. Simpson
K182078 08/02/2018 MiniCollect K2E K2EDTA Tubes Greiner Bio-One NA Inc. Manfred Abel
K182068 08/01/2018 Erran Dental Zirconia Hangzhou Erran Technology Co., Ltd. Tingkai Li
K182357 08/30/2018 HardyDisk AST Eravacycline 20?g (ERV20) Hardy Diagnostics Anna Klavins
K182260 08/21/2018 PALACOS MV Heraeus Medical GmbH Ute Greiner
DEN180047 08/31/2018 Aptima Mycoplasma genitalium Assay Hologic, Inc. Jeffrey Hergesheimer
K182373 08/31/2018 PowerLook Tomo Detection V2 Software iCAD Inc. John DeLucia
K182167 08/10/2018 The ICHOR Panacea Vascular Embolectomy Catheter System ICHOR Vascular, Inc. Jeff Blair
K182264 08/21/2018 ICONN Revolution Knotless Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K182196 08/14/2018 Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth Imediplus, Inc. Moriah Hsieh
K182298 08/24/2018 hemochroma PLUS System Immunostics, Inc. Junghee Kim
K182233 08/17/2018 Apiration Guide Catheter ; FlowTriever Catheter Inari Medical Eben Gordon
K182112 08/06/2018 Sense System with IBT Electrodes Infinite Biomedical Technologies, LLC Rahul Kaliki
K182325 08/27/2018 InMode RF System Inmode MD Ltd. Amit Goren
K182265 08/21/2018 CodMan Certas Plus Programmable Valve Integra LifeSciences Corp. Nancy MacDonald
K182114 08/06/2018 FlareHawk Interbody Fusion System Integrity Implants Inc Lauren Kamer
K182140 08/07/2018 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc Brandon Hansen
K182130 08/06/2018 iSchemaView RAPID iSchemaView, Inc. Jim Rosa
K182117 08/06/2018 Vinyl Patient Examination Gloves Jiangxi Zhonghong Pulin Medical Products Co., Ltd Joe Zhang
K182182 08/13/2018 YUKON OCT Spinal System K2M Nancy Giezen
K182210 08/15/2018 TiWAVE-L Porous Titanium Lumbar Cage Kalitec Medical, LLC Scott Winn
K182162 08/10/2018 OptiBond eXTRa Universal Kerr Corporation Mohammad Saad Ansari
K182153 08/08/2018 Ultrasound System SONIMAGE HS1 KONICA MINOLTA, INC. Tsutomu Fukui
K182380 08/31/2018 AEON Endoscopic Stapler Lexington Medical, Inc. Douglas MacBride
K182348 08/29/2018 14HK701G-W LG Electronics Inc. Jinhwan Jun
K182099 08/03/2018 Delta TT Pro Limacorporate S.p.A. Roberto Gabetta
K182354 08/29/2018 SafeAir Telescopic Smoke Pencil LiNA Medical ApS Natalia Szychulska
K182177 08/10/2018 Accipiolx MaxQ-Al Ltd. Joshua Schulman
K182077 08/01/2018 Mazor X System (Mazor X Stealth Edition) Mazor Robotics Ltd. Marina Hefetz
K182191 08/13/2018 Invia Abdominal Dressing Kit Medela AG Judith Bernardo
K182352 08/29/2018 SP-LINKÖ System Medical Designs LLC Kristi Vondra
K182240 08/20/2018 PASS LP Spinal System Medicrea International S.A. David Ryan
K182079 08/02/2018 Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask MEDTEC Inc. dba CIVCO Medical Solutions Alena Newgren
K182104 08/03/2018 NavLock Trackers, Robotic Reference Frame Medtronic Navigation Jainam Shah
K182121 08/06/2018 CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition Medtronic Sofamor Danek USA, Inc. Erikka Edwardsen
K182119 08/06/2018 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, Inc. Ankit K. Shah
K182119 08/06/2018 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, Inc. Ankit K. Shah
K182335 08/28/2018 CPX 4 Breast Tissue Expander with Smooth Surface Mentor Worldwide LLC Martin Sprunck
K182290 08/23/2018 IBM iConnect Access Merge Healthcare Incorporated Tracey Fox
K182216 08/15/2018 Merit Syringe Merit Medical Systems, Inc John Skousen
K182279 08/22/2018 Merit Syringe Merit Medical Systems, Inc. John Skousen
K182242 08/20/2018 VO200 û NeurOs Cerebral Oximetry System Mespere LifeSciences Inc. Rebecca S. Li
K182097 08/03/2018 React 71 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K182101 08/03/2018 Riptide Aspiration System (React 71 Catheter) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K182125 08/06/2018 EVOLUTION Stemmed CS Femur MicroPort Orthopedics Inc. Hunter Ethan Williams
K182207 08/15/2018 TR90BH MinXray, Inc Keith Kretchmer
K182228 08/16/2018 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments MIS Implants Technologies Ltd. Arbel Shezaf
K182297 08/24/2018 Surveyor S2 Mortara Instrument Inc Marco Manduchi
K182178 08/13/2018 neoBLUE blanket LED Phototherapy System Natus Medical Incorporated Judy Buckham
K182263 08/21/2018 RetCam 3 ; RetCam Shuttle ; RetCam Portable Natus Medical Incorporated Brian R. Ackley
K182195 08/14/2018 ArcoÖ-SA Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K182227 08/16/2018 Esprit Nova Neurozone MSH Incorporated Daniel Ramirez Rodriguez
K182201 08/14/2018 StratumÖ Foot Plating System Nextremity Solutions, Inc. Adam Finley
K182340 08/28/2018 NICO Myriad NICO Corporation Sean Spence
K182261 08/21/2018 NvisionVLE Imaging System, NvisionVLE Optical Probe NinePoint Medical, Inc. Eman Namati
K182317 08/27/2018 AMADEO M-DR mini, AMADEO M-AX mini OEHM UND REHBEIN GMBH Markus Brueggmann
K182120 08/06/2018 Maxpower Relief Omron Healthcare, Inc. Renee Thornborough
K182166 08/10/2018 Wrist Blood Pressure Monitor Model BP4350 Omron Healthcare, Inc. Renee Thornborough
K182127 08/06/2018 Wrist Blood Pressure Monitor Model BP6100 Omron Healthcare, Inc. Renee Thornborough
K182327 08/27/2018 Patient Cables and Leadwires , Disposable ECG Leadwires Orantech Inc. Hsin Xiong
K182274 08/22/2018 Orbit Subretinal Delivery System Orbit Biomedical, Inc. Michael Keane
K182360 08/30/2018 Teleport Microcatheter OrbusNeich Medical Trading Inc. John Pazienza
K182085 08/02/2018 Balanced Knee Revision System Trabecular Tibial Cone Augments Ortho Development Corporation Adrienne von Foller
K182072 08/01/2018 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides Ortho-Clinical Diagnostics, Inc. Marlene Hanna
K182063 08/01/2018 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System Ortho-Clinical Diagnostics, Inc. Marlene Hanna
K182286 08/23/2018 Oh'Care Lite Smart Blood Glucose Monitoring System OSANG Healthcare Co., Ltd. Jin Ho An
K182096 08/03/2018 Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs Owens & Minor Halyard, Inc. Angela L. Bunn
K182307 08/24/2018 Small Bone Phantom« Intramedullary Nail System; TTC Phantom« Intramedullary Nail System Paragon 28, Inc Eric Lintula
K182148 08/08/2018 SILVERBACK Gorilla Plating System Paragon 28, Inc. Eric Lintula
K182296 08/24/2018 HyperFil-LV Parkell, Inc. David Mott
K182181 08/13/2018 Persyst 14 EEG Review and Analysis Software Persyst Development Corporation Dari Darabbeigi
K182353 08/29/2018 EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay Phadia AB Carina Magnusson
K182115 08/06/2018 Vinyl Patient Examination Gloves Ping An Medical Products Co., Ltd. Fu Dong Zhang
K182157 08/09/2018 BioSign Flu A+B Princeton BioMeditech Corp. Kyung-ah Kim
K182144 08/08/2018 Bi-Flex Evo Promepla Sam Alexandre Bareille
K182189 08/13/2018 Encompass SRS Headframe ; Encompass MR SRS Headframe Qfix Alexandra Low Smythe
K182213 08/15/2018 QT Ultrasound Breast Scanner - 1 QT Ultrasound LLC Mark W. Lenox
K182211 08/15/2018 Aurora Surgiscope System Rebound Therapeutics Corporation Jane Metcalf
K182218 08/15/2018 FerriSmart Analysis System Resonance Health Analysis Services Pty Ltd Celine Royet
K182095 08/03/2018 Tina-quant Transferrin ver.2 (urine application) Roche Diagnostics Operations (RDO) Lindsay Jones
K182370 08/31/2018 Acculoc Total Knee System RootLoc Co., Ltd. Jungsun Ha
K182183 08/13/2018 GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A Samsung Electronics Co., LTD. Jaesang Noh
K182237 08/17/2018 uMI 550 PET/CT System Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K182111 08/06/2018 DL Self-adhesive Electrode Shaoxing DL Healthcare Co., Ltd. Zhao Qingya
K182190 08/13/2018 Fetal Doppler Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao
K182133 08/06/2018 Infrared Thermometer Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao
K182289 08/23/2018 Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Baoan Medical Supplies Co., Ltd Mingan Mu
K182291 08/23/2018 6MP Color LCD Monitor (C61W+) Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K182075 08/01/2018 BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K182165 08/10/2018 Color Doppler Ultrasound System; Model: mEye1 and mEye2 Shenzhen Well.D Medical Electronics Co., LTD. Ning Bai
K182098 08/03/2018 N Latex FLC kappa assay, N Latex FLC lambda assay Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K182208 08/15/2018 syngo.via View&GO (Version VA10A) Siemens Healthcare GmbH Elango Alampalayam Rangappan
K182299 08/24/2018 MAGNETOM Aera Siemens Medical Solutions USA Inc. Martin Rajchel
K182129 08/06/2018 MAGNETOM Sola Siemens Medical Solutions USA, Inc. Cordell L. Fields
K182179 08/13/2018 AdvantageRib Anterior System SIG Medical Corp. Andrew Davison
K182323 08/27/2018 PICO 7Y Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Shruthi Bhat
K182109 08/03/2018 REDAPT Modular Acetabular Shell Smith & Nephew, Inc. Meenakshi Gupta
K182146 08/08/2018 Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set Sol-Millennium Medical, Inc. James Barley
K182082 08/02/2018 Tumark for Eviva, Tumark for Brevera Somatex Medical Technologies GmbH Burkhard Jakob
K182322 08/27/2018 Duo Lumbar Interbody Fusion Device Spineology Inc Karen Roche
K182345 08/28/2018 Spineology Navigation Instruments Spineology Inc Karen Roche
K182160 08/09/2018 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM Stryker April Malmborg
K182305 08/24/2018 Stryker Facial iD Plating System Stryker Zainab Amini
K182359 08/30/2018 HipCheck Stryker Corp. Cara Mellits
K182336 08/28/2018 SubtlePET Subtle Medical, Inc. Enhao Gong
K182171 08/10/2018 SMV Scientific K-Wire and Pins Summit MedVentures Nephi Zufelt
K182156 08/09/2018 Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Syntex Healthcare Products Co., Ltd Qiao Zhiqiang
K182154 08/09/2018 Depuy Synthes Femoral Neck System Synthes (USA) Products, LLC Stephan Jepards
K182062 08/01/2018 Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device Sysmex America, Inc. Jessica Rivera-Montejo
K182110 08/06/2018 CDI Blood Parameter Monitoring System 550 Terumo Cardiovascular Systems Corporation Bryan K. Hann
K182198 08/14/2018 Panoura X-ERA PF/NF/MF The Yoshida Dental Mfg. Co., Ltd. Hidenori Watanabe
K182376 08/31/2018 Harmony Topcon Medical Systems, Inc. James Lorkowski
K182206 08/15/2018 RiX70 DC Trident s.r.l Giorgio Rizzo
K182284 08/23/2018 Tyber Medical PT Interbody Spacer Tyber Medical LLC Mark F. Schenk
K182105 08/03/2018 JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant United Consortium Stephanie Morris
K182258 08/21/2018 AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm United States Endoscopy Group, Inc. Carroll L. Martin
K182232 08/17/2018 Octane Mechanical Thrombectomy System Vascular Solutions, Inc. Iroquois Ledbeter
K182094 08/03/2018 Family of Venus RF Systems - Heal Venus Concept USA Inc. Yoni Iger
K182230 08/17/2018 Multi Modality Viewer Vital Images, Inc. Fei Li
K182247 08/20/2018 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) VizionFocus, Inc. Angus Shih
K182310 08/24/2018 Volpara Imaging Software Volpara Health Technologies Limited Ralph Highnam
K182381 08/31/2018 Wilson-Cook Mini Basket Wilson-Cook Medical, Inc Tiffanny A. Thomas
K182319 08/27/2018 Glo-Tip Spray Catheter Wilson-Cook Medical, Inc. Paula Joyce
K182080 08/02/2018 Scope Antifogging System Xodus Medical, Inc. Paul Lloyd
K182093 08/03/2018 ZOLL ECG Analysis Software ZOLL Manufacturing Corporation Zachary Nelson


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact