FDA 510(k) Applications Received During June, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K201494 06/05/2020 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card Advin Biotech, Inc. Daniel Hsu
K201631 06/16/2020 VersaWrap Nerve Protector Alafair Biosciences Inc Angela Mallery
K201521 06/08/2020 Medina Anterior Cervical Plate System Alliance Partners, LLC Desiree Crawford
K201517 06/08/2020 Plain Surgical Mask AOK Tooling Limited Francis Nithyananthan
K201552 06/10/2020 ApolloVue S100 Image System Apollo Medical Optics, Ltd. Chi-Hua Wu
K201677 06/19/2020 Arthrex Mesh Plates Arthrex Inc. Rebecca R Homan
K201786 06/30/2020 Arthrex Mini Hip PushLock Arthrex Inc. Kelsey Roberts
K201749 06/26/2020 Arthrex SwiveLock Anchor Arthrex Inc. Jessica Singelais
K201522 06/08/2020 Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Arthrex Inc. Rebecca R. Homan
K201542 06/09/2020 Arthrex Eclipse Shoulder Prosthesis System Arthrex, Inc. David L Rogers
K201779 06/30/2020 HotDog Temperature Management Controller Augustine Temperature Management Temi Ogunse
K201532 06/08/2020 B&J DVT Calf/Thigh Garments, Models 801/830 Series B & J Manufacturing Ltd. Billy Yu
K201547 06/09/2020 B&J DVT Foot Garments, Models 820 Series B&J Manufacturing Ltd. Billy Yu
K201539 06/09/2020 Keeogo Dermoskeleton System B-Temia Inc. Alexandre Jokic
K201464 06/02/2020 Altapore MIS Baxter Healthcare Corporation Phillip Romei
K201668 06/19/2020 VarseoSmile Crown plus BEGO Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG Tanja Goetz
K201641 06/16/2020 Disposable Laparoscope Trocar Beijing Biosis Healing Biological Technology Co., Ltd. Jiali Zhou
K201750 06/26/2020 Pentaray Nav eco High-Density Mapping Catheter Biosense Webster, Inc Richard Lauhead
K201751 06/26/2020 Pedicle Screw System Black Box Medical LLC Todd Stanaford
K201713 06/23/2020 AVVIGO Guidance System Boston Scientific Corporation Kevin Catalano
K201792 06/30/2020 TRUSELECT Microcatheter Boston Scientific Corporation Aoife Tobin
K201738 06/25/2020 SubNovii Advanced Plasma Technology Cartessa Aesthetics Gabe Lubin
K201642 06/17/2020 Paragon Adult Maxi PMP Oxygenator with Tubing Pack Chalice Medical Ltd Stephen Horan
K201593 06/12/2020 Looking Glass 4K Integrated Visualization System ConMed Corporation Kavita Amin
K201672 06/19/2020 Signia Stapler (with new software) Covidien Katherine Y Choi
K201479 06/04/2020 DemeMASK DemeTECH Corporation Tracy Chadwrick
K201505 06/05/2020 Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K201442 06/01/2020 Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers Diatron Group Frank Matuszak
K201476 06/03/2020 DreaMed Advisor Pro DreaMed Diabetes Ltd Inbal Beinglass Peled
K201605 06/15/2020 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage EIT Emerging Implant Technologies GmbH Barbara Wirth
K201430 06/01/2020 InFrameÖ Cannulated Fixation System ExsoMed, Corp. Jung Chang
K201556 06/10/2020 Intraosseous Fixation System Extremity Medical, LLC. Mary Hoffman
K201472 06/03/2020 VenSure Balloon Device, VenSure Nav Balloon Device Fiagon GmbH Dirk Mucha
K201530 06/08/2020 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) Hartalega Ngc Sdn. Bhd. Kuan Mun Leong
K201772 06/29/2020 Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC Sdn. Bhd. Kuan Mun Leong
K201531 06/08/2020 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega SDN. BHD. Kuan Kam Hon
K201513 06/08/2020 Quantra QPlus System HemoSonics, LLC Anne Zavertnik
K201722 06/23/2020 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System Hyperfine Research, Inc. Robert Fasciano
K201551 06/09/2020 KetoSens BT Blood B-Ketone Monitoring System i-SENS, Inc. Joon Ho Jung
K201798 06/30/2020 myQA iON IBA Dosimetry GmbH Andreas Suchi
K201570 06/11/2020 PF4 Enhanced assay Immucor GTI Diagnostics, Inc. Allison Stray
K201636 06/16/2020 Hercules Suture Anchor System In2Bones USA, LLC Christine Scifert
K201621 06/15/2020 Magicore II System InnoBioSurg Co., Ltd. Bo-Yeon Lim
K201614 06/15/2020 TxTiHA IBF System, AxTiHA Stand-Alone ALIF System Innovasis, Inc. Marshall McCarty
K201780 06/30/2020 True Tulip System, True M.I.S. System Innovative Surgical Designs, Inc. Jon Rinehart
K201507 06/05/2020 Cadence Total Ankle System Integra Lifesciences Corporation Cassidy Lemkau
K201676 06/19/2020 Barricaid Instrument Tray Intrinsic Therapeutics, Inc. Regina Shih
K201656 06/18/2020 ARIX Elbow System Jeil Medical Corporation Sejin Ryu
K201470 06/03/2020 Disposable Medical Face Mask JKH USA, LLC Bill Quanqin Dai
K201645 06/17/2020 Massage Compression Boots JKH USA, LLC Bill Quanqin Dai
K201591 06/12/2020 Flat Panel Detector KA Imaging Inc. Samuel To
K201571 06/11/2020 ACTIV.A.C. Negative Pressure Wound Therapy System KCI USA, Inc Jesus Valencia
K201660 06/18/2020 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K201500 06/05/2020 Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer Life Spine Inc. Angela Batker
K201538 06/09/2020 Life Spine SIMPACT Sacroiliac Joint Fixation System Life Spine Inc. Angela Batker
K201721 06/23/2020 TruLift Expandable Spacer System Life Spine Inc. Angela Batker
K201663 06/19/2020 AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories Lumenis Ltd. Shlomit Segman
K201432 06/01/2020 Masimo O3 Regional Oximeter System Masimo Corporation Sindura Penubarthi
K201673 06/19/2020 SMS Cementless Stem Medacta International SA Stefano Baj
K201506 06/05/2020 Talos«-C Cervical Intervertebral Body Fusion System, Talos«-C (HA) Cervical Intervertebral Body Fusion System Meditech Spine, LLC Bruce Dunaway
K201661 06/18/2020 Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set Medos International, SARL Nicole Aeschbacher
K201449 06/01/2020 SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring Medtronic, Inc. Lisa Corbin
K201765 06/29/2020 SmartHDM-510 System Mesa Laboratories, Inc. Jamie Louie
K201690 06/22/2020 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Prerana Gurubasavaraj
K201689 06/22/2020 Riptide Aspiration System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Kristy Ann Darling
K201487 06/04/2020 Traxcess 7 Mini Guidewire Micro Vention Inc. Ganesh Balachandar
K201488 06/04/2020 Rover Micro-X Ltd. Mark Norman
K201667 06/19/2020 Midmark Extraoral Imaging System (EOIS) Midmark Corporation Mark Kenar
K201575 06/11/2020 CMDR 2C (Multiple Models) MinXray, Inc Keith Kretchmer
K201549 06/09/2020 Motex Anti-Fog Surgical Face Mask Modern Healthcare Corp. Ke-Min Jen
K201619 06/15/2020 EndoTool IV System Monarch Medical Technologies, LLC Ann Marie Gaitan
K201618 06/15/2020 Nalu Neurostimulation SCS system Nalu Medical, Inc Michele Chin-Purcell
K201769 06/29/2020 Cavetto [MAX] Cervical Cage System NeuroStructures, Inc. Moti Altarac
K201623 06/15/2020 LION Photocoagulator Norlase ApS Jan Forstberg
K201543 06/09/2020 MAGEC« System NuVasive Specialized Orthopedics, Inc. Ivanna Lopez
K201567 06/11/2020 Precice« Bone Transport System NuVasive Specialized Orthopedics, Inc. Madison Heffron
K201794 06/30/2020 Jade OrbusNeich Medical (Shenzhen) Co., Ltd. Daniel Zhang
K201481 06/04/2020 Centurion POCT System Orthofix Inc. Jacki Koch
K201664 06/19/2020 FIREBIRD SI Fusion System Orthofix Inc. Jacki Koch
K201503 06/05/2020 Edge Air(1417) Digital Flat Panel X-ray Detector Osko, Inc. Richard Jeon
K201704 06/22/2020 CoFix System Paradigm Spine GmbH Branko Sostarko
K201725 06/23/2020 DigitalDiagnost C50 Philips Healthcare (Suzhou) Co., Lit. Claire Zhang
K201640 06/16/2020 DuraDiagnost Philips Healthcare (Suzhou) Co., Ltd. Mary Zhu
K201665 06/19/2020 Collaboration Live Philips Ultrasound, Inc. Colin S. Jacob
K201774 06/29/2020 Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs PT. Medisafe Technologies Sajeev Joseph
K201691 06/22/2020 Single-Use Surgical Mask With Ear Loop Qiqihar Hengxin Medical Supplies, Ltd. Sihui Xiong
K201455 06/01/2020 Litho 150, Cyber Ho 150 Quanta System Spa Francesco Dell'Antonio
K201502 06/05/2020 Vitra 810 Quantel Medical Bruno Pages
K201796 06/30/2020 1717SCV, 1717SGV Rayence Co., Ltd. Kee Dock Kim
K201637 06/16/2020 Aurora Evacuator +Coag Rebound Therapeutics Naomi Gong
K201746 06/26/2020 Tempus Pro Patient Monitor Remote Diagnostic Technologies Limited Timothy Bubb
K201518 06/08/2020 Route 92 Medical 088 Access System Route 92 Medical Kathy Tansey
K201648 06/18/2020 SterispineÖ PS Safe Orthopaedics Pierre Dumouchel
K201760 06/29/2020 Zoom 14 Guidewire Scientia Vascular LLC Amy McManus
K201646 06/17/2020 Shoreline ACS (Anterior Cervical System) SeaSpine Orthopedics Corporation Alicia McArthur
K201537 06/08/2020 Protective Face Mask for Medical Use Shandong Shengquan New Material Co., Ltd. Xiumei Zhang
K201731 06/24/2020 Diode Laser Body Sculpture System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K201540 06/09/2020 uMR570 Shanghai United Imaging Healthcare Co.,Ltd. Xin GAO
K201599 06/12/2020 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K201693 06/22/2020 DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Zhang Wei
K201477 06/03/2020 syngo.via View&GO Siemens Healthcare GmbH Elango Alampalayam Rangappan
K201462 06/02/2020 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Sulgue Choi
K201444 06/01/2020 Syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. Cynthia Busch
K201662 06/19/2020 REDUCT« Headless Compression Screw System Skeletal Dynamics, Inc. Diana Taylor
K201527 06/08/2020 EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) Smith & Nephew, Inc. Kayla Franklin
K201597 06/12/2020 Liver Incytes, Model 1005 Sonic Incytes George Aliphtiras
K201450 06/01/2020 Straight T Clear Dental Aligner Straight T, Inc. Minh Trinh
K201434 06/01/2020 Connected OR Hub with Voice Control, Connected OR Hub with Device Control Stryker Meagan Jones
K201585 06/11/2020 Monterey AL Interbody System Stryker Corporation Alexia Haralambous
K201715 06/23/2020 Smart Toe II, X Fuse Stryker GmbH Jemin Dedania
K201511 06/05/2020 Reprocessed Endoscopic Trocars and Sleeves Stryker Sustainability Solutions Ramona Kulik
K201699 06/22/2020 Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Surgical Instrument and Savings Inc (dba Medline ReNewal) Stephanie Boyle Mays
K201465 06/02/2020 SuRgical Planner (SRP) BrainStorm Surgical Theater, Inc. Kevin Murrock
K201578 06/11/2020 DePuy Synthes Variable Angle Locking Patella Plating System Synthes (USA) Products, LLC Enrico Gindro
K201616 06/15/2020 SyMRI SyntheticMR AB Raymond Kelly
K201633 06/16/2020 Terason uSmart 3200T Plus Ultrasound System Teratech Corporation Benjamin Chiampa
K201632 06/16/2020 TOMTEC-ARENA TOMTEC Imaging Systems GmbH Marc Bergenthal
K201607 06/15/2020 Eclipse Treatment Planning System v16.1 Varian Medical Systems, Inc Peter J. Coronado
K201588 06/12/2020 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice Varian Medical Systems, Inc. Peter J. Coronado
K201586 06/11/2020 XACT Robotic System XACT Robotics Ltd. Chen Levin


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