FDA 510(k) Decisions During October, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K191771 10/16/2019 SECURE Screw A.M. Surgical, Inc. Vincent Pascale
K192593 10/18/2019 Confirm Rx Insertable Cardiac Monitor Abbott Laura Sparks
K192175 10/17/2019 On Call Express II Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K191431 10/07/2019 Interlude Rolled Tampons in Plastic Applicator ALBAAD fem Shlomo Helvits
K182143 10/03/2019 ALFA GATE Dental Implants System Alfa Gate Mazen Ltd Mohamad Zahalka
K192541 10/16/2019 DigiX FDX Allengers Medical Systems Limited Sanjeev K. Marjara
K191723 10/18/2019 ATEC IOM Accessory Instruments Alphatec Spine, Inc. Ruby Zheng
K191843 10/04/2019 Ceramill A-Temp Amann Girrbach AG Debora Engel
K192434 10/15/2019 DualX Lumbar Intervertebral Body Fusion Device Amplify Surgical Inc Andy Choi
K190183 10/04/2019 Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Gang Yu
K191326 10/15/2019 Arthrex Mini Comprehensive Fixation System û 1.4mm & 1.6mm Module Arthrex Inc. Rebecca R. Homan
K191344 10/03/2019 Arthrex Mini Comprehensive Fixation System û 2.0mm & 2.4mm Module Arthrex Inc. Rebecca R. Homan R. Homan
K192532 10/19/2019 Arthrex SwiveLock Anchor Arthrex Inc. Ivette Galmez
K192441 10/17/2019 Arthrex SwiveLock Anchors Arthrex Inc. Jessica L. Singelais
K190953 10/16/2019 Arthrex Minimally Invasive Ankle Fusion Plate Arthrex, Inc. Caroline Bloemker
K191099 10/03/2019 Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel Atlas Medical Amani AL-Habahbeh
K190149 10/15/2019 Vial Adapter ?20 mm Avenir Performance Europeenne Medical (APEM) Fatoumata Dao
K183710 10/04/2019 Vivio System Avicena LLC Sean Brady
K192318 10/03/2019 Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Bard Peripheral Vascular, Inc. Andrew Quach
K192556 10/17/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Jocelyn Kersten
K192005 10/04/2019 Bausch + Lomb PreVue Inserter for enVista Preloaded Bausch & Lomb, Inc Rekha Janarthanan
K190342 10/18/2019 BIAFINE Topical Cream Bausch Health Americas Incorporated Marci Halevi
K191513 10/19/2019 Altapore Shape Baxter Healthcare Corporation Phillip Romei
K190298 10/04/2019 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 Beckman Coulter Biomedical GmbH Amanda Brown
K191417 10/10/2019 Belun Ring Belun Technology Company Limited Leung Lap Wai Lydia
K190319 10/10/2019 Waterlase Laser System Family Biolase, Inc. Alicia Mszyca
K191150 10/08/2019 Bodycad Unicompartmental Knee System Bodycad Laboratories, Inc. Guy Sevigny
K191542 10/11/2019 Apyx Plasma/RF Handpiece Bovie Medical Corporation dba Apyx Medical Corporation Topaz Kirlew
K182073 10/17/2019 BcSs-PICNI-2000 Sensor Braincare desenvolvimento e Inovacao Tecnologica S.A. Arnaldo Betta
K192239 10/17/2019 WavelinQ Plus EndoAVF System C.R. Bard, Inc. Kulveen Dhatt
K192214 10/11/2019 CarboClear VBR System CarboFix Orthopedics Ltd. Yael Rubin
K191672 10/15/2019 NuFACE Mini Device Carol Cole Company dba NuFACE Nadia Vazirzadeh Miller
K192428 10/05/2019 AFX Femoral Implant with Inserter Cayenne Medical Shima Hashemian
K191174 10/10/2019 Mercy babyTAPE Children's Mercy Hospital Susan Abdel-Rahman
K191668 10/18/2019 Infrared Forehead Thermometer (Model IR-FT) Comper Chuangxiang (Beijing) Technology Co., Ltd. Han Du
K190084 10/11/2019 McLean-Ring Enteral Feeding Tube Set Cook Incorporated Paul Meyer
K191806 10/03/2019 Propex IQ Apex Locator Dentsply Sirona Karl Nittinger
K191779 10/08/2019 Attune Revision LPS Inserts Depuy (Ireland) Kathy Harris
K192448 10/04/2019 Delta Xtend Revers Shoulder System DePuy(Ireland) Ashley Goncalo
K191833 10/07/2019 Dexcom G6 Pro Continuous Glucose Monitoring System Dexcom, Inc. Jacob Nardone
K192064 10/02/2019 LIAISON Vitamin B12 DiaSorin Inc. John C. Walter
K190208 10/03/2019 Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe Diversatek Healthcare Laura L. Boll
K192453 10/01/2019 DIAMOND-5A/6A/8A DRGEM Corporation Ki-Nam Yang
K192400 10/03/2019 EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG DRTECH Corporation Choul-Woo Shin
K190124 10/20/2019 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One E.M.S Electro Medical Systems S.A. Gaelle Pacaud
K183479 10/03/2019 Asthma Monitor AM3 eResearchTechnology Kristin Feld
K190937 10/14/2019 Echelon Endopath Staple Line Reinforcement Ethicon Endo-Surgery LLC Emily Nesbitt
K192303 10/01/2019 ExactVu High Resolution Micro-Ultrasound System Exact Imaging Inc. Sam Rajkumar
K182773 10/08/2019 Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps Faulhaber Pinzetten OHG Dorothea Faulhaber
K192210 10/10/2019 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System Fiab SpA Francesco Batistini
K190713 10/11/2019 F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) Fisher & Paykel Healthcare Ltd. Masar Mohammad
K192422 10/04/2019 Steerable Introducer 12F Freudenberg Medical LLC Mary Prunty
K191544 10/18/2019 Synapse 3D Blood Flow Analysis Fujifilm Corporation Randy Vader
K192206 10/08/2019 32mm Glenosphere and Humeral Cup FX Shoulder USA, Inc. Kathy Trier
K192426 10/01/2019 Signa Voyager, Signa Voyager Quantum GE Healthcare(Tianjin) Company Limited Yuan Ma
K183171 10/08/2019 ScopeSeal Duodenoscope Protective Device GI Scientific LLC Scott Miller
K183681 10/11/2019 Protego Antimicrobial Wound Dressing Global Health Solutions (DBA Turn Therapeutics) Bradley Burnam
K183274 10/18/2019 RTHawk, HeartVista Cardiac Package HeartVista, Inc. James J. Rogers
K191216 10/17/2019 Voxel DosimetryÖ v1.0 Hermes Medical Solutions AB Joakim Arwidson
K191993 10/03/2019 Yumizen C1200 CRP Horiba ABX SAS Caroline Ferrer
K190465 10/18/2019 Evolve Breast Pump Hygeia II Medical Group, Inc. Brett Nakfoor
K191994 10/04/2019 ProFound AI Software V2.1 iCAD Inc. Heather Reed
K191458 10/10/2019 Legacy SMARTBase Abutments Implant Direct Sybron Manufacturing LLC Reina Choi
K183503 10/17/2019 EasyMark Tissue Marker INRAD Inc. Steve Field
K191659 10/10/2019 Instylla Delivery Kit Instylla, Inc. Amita Smith
K191684 10/11/2019 MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System Integra Lifesciences Corporation Omayra Ramirez
K191507 10/01/2019 Intellijoint« Navigation System Intellijoint Surgical Inc. Breanne Cuddington
K192200 10/09/2019 DynaCAD Invivo Corporation Kym Rupp
K192512 10/16/2019 Focus 35C Detector, Trimax 35C Detector iRay Technology Taicang Ltd. Meng Li
K191448 10/08/2019 Barrier Sleeves Ivoclar Vivadent, AG Sandra Cakebread
K181896 10/18/2019 LIPOcel Jeisys Medical, Inc. Sugun Lee
K191490 10/03/2019 Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe Jiangsu Caina Medical Co., Ltd. Xinyan Ruan
K190179 10/03/2019 SAHARA Stabilization System K2M, Inc. Oonagh Lahiff
K190820 10/02/2019 Aimanfun Lumea Comfort Kam Yuen Plastic Products Ltd Anna Dan
K191548 10/11/2019 Nexus Universal Self-Cure Kerr Corporation Ardrena Jackson
K191523 10/09/2019 Visalys Restorative Primer Kettenbach GmbH & Co. KG Katja Simon
K191133 10/08/2019 KATANA Cleaner, KATANA Cleaner (Trial) Kuraray Noritake Dental Inc. Yasujiro Ohara
K192208 10/09/2019 CORNICE Cervical Spacer System Legend Spine Technologies Steve Marinelli
K192235 10/11/2019 AEON Laparoscopic Instruments Lexington Medical, Inc. Douglas MacBride
K192325 10/18/2019 Quantum Blood and Fluid Warming System Life Warmer, Inc. John Pettini
K191963 10/10/2019 SMR Finned Short Stems LimaCorporate S.p.A Giuseppe Valenti
K192433 10/04/2019 LZI Methadone II Enzyme Immunoassay Lin-Zhi International, Inc Bernice Lin
K191942 10/17/2019 MT One Diamond M&T Srl Firorenzo Rossi
K192398 10/03/2019 Millenium HX Mar Cor Purification, Inc. Mike Halliday
K182184 10/10/2019 Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) MDK (ShangHai) Medical Packing Co., Ltd. Gong Yaoren
K191653 10/17/2019 Freestyle Flex Medela AG Judith Bernardo
K191958 10/01/2019 Aveta System Meditrina, Inc. Csaba Truckai
K190314 10/09/2019 Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 MedNovel Technology Ltd Jia Yu
K191943 10/18/2019 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set Medos International, SARL Daria Bochenek
K190840 10/15/2019 Medtronic Transportation / Sterilization Cassettes Medtronic Sofamor Danek USA, INC. Elizabeth Hamilton
K191066 10/03/2019 CD HorizonÖ AstuteÖ Spinal System Medtronic Sofamor Danek, USA Inc. Bhavya Vendra
K191526 10/01/2019 Cardioblate CryoFlex Surgical Ablation System Medtronic, Inc. Choua Thao
K191127 10/08/2019 Advanced Intermezzo Implant System MegaGen Implant Co., Ltd. JiYoung Son
K182448 10/09/2019 AnyRidge Octa 1 Implant System MegaGen Implant Co., Ltd. HyeJin Jung
K192455 10/17/2019 Merge PACS Merge Healthcare Incorporated Amy Tannenbaum
K191596 10/09/2019 Arcadia Balloon Catheter Merit Medical Systems, Inc. Shamsa Karimi
K190086 10/07/2019 Cepheid Xpert Respiratory Control Panel Microbiologics, Inc. Tina Sobania
K191632 10/07/2019 PROFEMUR TL2 Stems MicroPort Orthopedics Inc. Sneh Pingle
K183462 10/01/2019 Applied Biosystems Bacillus anthracis Detection Kit MRIGlobal Fran White
K191822 10/11/2019 Nano FortiCore, FortiCore Nanovis LLC Matthew Hedrick
K191363 10/02/2019 Neocis Planning Software Application (NPSA) for 3rd Party PCs Neocis Inc. Thomas ("Ted") E. Claiborne
K192427 10/03/2019 Ablation Confirmation NeuWave Medical, Inc. Neda Chini
K191181 10/11/2019 NXPRO Neuromuscular Electrical Stimulation Device NeuX Technologies, Inc. Scot Minniear
K191889 10/02/2019 NG-Test CARBA 5 NG Biotech Milovan Stankov-Puges
K191359 10/09/2019 Nipro Syringe Nipro Medical Corporation Jessica Oswald-McLeod
K192760 10/18/2019 NuVasive Modulus XLIF Interbody System NuVasive, Incorporated Jessica LeBlanc
K190636 10/19/2019 NuVasive« Reline« 4.5-5.0 System NuVasive, Incorporated Ivanna Lopez
K190772 10/10/2019 SURGICAL MICROSCOPE SYSTEM ORBEYE with IR OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K191713 10/04/2019 CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShieldÖ (ROI Assembly) Omega Medical Imaging, LLC John Newman
DEN190025 10/10/2019 OraQuick Ebola Rapid Antigen Test OraSure Technologies, Inc. Tiffany Miller
K190162 10/17/2019 SmartCeph Ortho2, LLC Amy Schmidt
K190321 10/09/2019 Pediatric Nailing PlatformFemur OrthoPediatrics, Corp. Jen Gregory
K190102 10/17/2019 DyeVertÖ Plus Contrast Reduction System, DyeTectÖ Contrast Monitoring System, DyeVertÖ Plus EZ Contrast Reduction System Osprey Medical Inc. Melanie Hess
K190523 10/10/2019 Cranial PSI Accessory û Anatomical Model Original, Cranial PSI Accessory û Anatomical Model Modified, Cranial PSI Accessory û Plastic Drawing Guide, Cranial PSI Accessory û Cranial Implant Trial OssDsign AB Ulrik Birgersson
K192147 10/10/2019 Halyard ONE-STEP* Sterilization Wrap Owens & Minor (O&M) Halyard, Inc Steven Dowdley
K191783 10/09/2019 Parcus Synd-EZ Ti Parcus Medical, LLC Paul Vagts
K191687 10/09/2019 pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire phenox Limited Gary Brogan
K191854 10/08/2019 Premia Spine XL Instruments Premia Spine, Ltd. Ron Sacher
K183589 10/11/2019 PMT Facet Screw Providence Medical Technology, Inc. Edward Liou
K190646 10/18/2019 QT Scanner 2000 Model A QT Ultrasound, LLC Rajni Natesan
K192566 10/17/2019 Reach and CQ'ENCE Circular Staplers Reach Surgical, Inc. Mark Goldin
K192474 10/10/2019 VERA Reflexion Health, Inc. Walter Cordiglia
K183226 10/18/2019 Care Orchestrator Essence Respironics Inc. Michelle Brinker
K183625 10/18/2019 SomnaPatch Respironics, Inc. Amy Panzik
K190486 10/16/2019 Pitkar External Fixation System S H Pitkar Orthotools Pvt Ltd. Vivek Mangalwedhekar
K191436 10/18/2019 Saalio Saalmann medical GmbH & Co. KG Rolf Eilers
K190591 10/04/2019 Safergel Sterile Ultrasound Gel Safersonic US, Inc. David L. Seitelman
K192316 10/17/2019 Matrix HA PEEK Cervical Implant System Sapphire Medical Group Anthony Ruggiero
K190630 10/09/2019 SolidAIRity III Airway Stabilization System Securisyn Medical, LLC Arthur Kanowitz
K191610 10/01/2019 RTapp SegAna, LLC Rodney Bosley
K183441 10/04/2019 Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Semperit Investments Asia PTE LTD. Andreas Woess
K190795 10/18/2019 Tetragraph Neuromuscular Transmission Monitor Senzime AB Johanna Faris
K192515 10/11/2019 BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K191251 10/15/2019 Infared Thermometer Shenzhen Calibeur Industries Co., Ltd. Weibin He
K191420 10/11/2019 Reusable SpO2 Sensor Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K183674 10/11/2019 Electronic Pulse Stimulator Shenzhen Leading Perfection Technology Co., Ltd Simon Hou
K182136 10/10/2019 Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) Shenzhen OSTO Technology Co., Ltd. Li Yang
K191430 10/18/2019 Pulse Oximeter Shenzhen Yimi Life-Technology Co.,Ltd. Shande Peng
K191794 10/03/2019 Vintage Art Universal Shofu Dental Corporation Mauro Malzyner
K192526 10/10/2019 Spine Wave Navigated Instruments Spine Wave, Inc. Amy Noccioli
K190386 10/10/2019 KTA Adipose Treatment Kit Stemics S.A.S Stephane Giraud
K192128 10/04/2019 Sutter Arrowtip Monopolar Electrodes Sutter Medizintechnik GmbH Ulrike Zeissler
K191283 10/18/2019 Infrared Thermometer, Breeze model Suzhou Melodicare Medical Technology Co.,Ltd. Xiaoqian Zou
K192057 10/11/2019 K-Pack II Needle - 27G x 1/2ö Extra Thin Wall, K-Pack II Needle - 27G x 1/2ö Ultra Thin Wall, K-Pack II Needle - 30G x 1/2ö Extra Thin Wall, K-Pack II Needle - 30G x 1/2ö Ultra Thin Wall Terumo Europe N.V. M. J. Aerts
K192250 10/16/2019 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL Thermo Fisher Scientific Cynthia Knapp
K191369 10/08/2019 TSolution One Total Knee Application THINK Surgical, Inc. Meliha Mulalic
K192598 10/18/2019 Bashir S-B Endovascular Catheter Thrombolex, Inc. Amy Katsikis
K190940 10/04/2019 Tokuyama Rebase III Tokuyama Dental Corporation Keith A. Barritt
K191480 10/11/2019 Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) Trigg Laboratories, Inc. D/B/A Wet International Louie Goryoka
K191902 10/11/2019 Razor, Everest, U&C Liquid U&C International Co., Ltd. Jong-min Kim
K191932 10/02/2019 MomentumÖ Posterior Spinal Fixation System Ulrich Medical USA Hans Stover
K192185 10/09/2019 The Cellfina System Ulthera, Inc Lisa Pray
K190060 10/04/2019 Urethrotech UCD Urethrotech Daniela Andrich
K191208 10/11/2019 Spectra Cashmere Uzinmedicare Co. Nathan Ahn
K191010 10/10/2019 Palladium High Flow Therapy System Vapotherm, Inc. Richelle Helman
K192424 10/03/2019 Mobius3D Varian Medical Systems, Inc Peter J. Coronado
K191493 10/16/2019 Ventripoint Medical System Plus (VMS+) 3.0 Ventripoint Diagnostics, Ltd. Desmond Hirson
K192465 10/10/2019 DigiFix Sterile Kit Virak Orthopedics, LLC Virak Tan
K191397 10/02/2019 OxySoft (olifilcon C) silicone hydrogel soft contact lens Visco Vision Inc. Evan Huang
K190538 10/07/2019 NIO-I WaisMed Ltd Maya Shuvi
K191332 10/03/2019 XACT Robotic System XACT Robotics Ltd. Chen Levin
K192416 10/01/2019 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System Zimmer GmbH Roberto Tommasini
K192312 10/11/2019 Zimmer Natural Nail System Cephalomedullary Nails Zimmer GmbH Annemie Rehor Kausch
K192194 10/15/2019 TotalShield II Surgical Helmet System Zimmer Surgical, Inc Abigail Miller


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