| 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 |
