| K201497 — EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) Oct 28, 2020 |
| K202089 — LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. Oct 28, 2020 |
| K202259 — Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip | Parcus Medical, LLC Oct 28, 2020 |
| K193038 — Comprehensive Shoulder System | Biomet Manufacturing Corp Oct 28, 2020 |
| K200790 — LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. Oct 28, 2020 |
| K200153 — Bright Bond Universal | Genoss Co., Ltd. Oct 28, 2020 |
| K203005 — Mazor X | Mazor Robotics , Ltd. Oct 27, 2020 |
| K193084 — TIB Abutment System | Southern Implants (Pty), Ltd. Oct 27, 2020 |
| K200273 — FREEPRINT temp | Detax GmbH & Co. KG Oct 27, 2020 |
| K202887 — IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. Oct 27, 2020 |
| K201627 — Dental Computed Tomography X-Ray System, Green X | VATECH Co., Ltd. Oct 27, 2020 |
| K202519 — OrthoNext Platform System | Orthofix Srl Oct 27, 2020 |
| K200156 — Bright Low Flow | Genoss Co., Ltd. Oct 27, 2020 |
| K202152 — NextAR TKA Platform | Medacta International S.A. Oct 27, 2020 |
| K203099 — Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Oct 27, 2020 |
| K202960 — General Cutting Contra Handpiece | Nakanishi, Inc. Oct 27, 2020 |
| K202722 — 1212FCA | Rayence Co., Ltd. Oct 26, 2020 |
| K200150 — Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) | Medline Industries, Inc. Oct 26, 2020 |
| K202065 — DOLOMITE Anterior Cervical Stabilization System | Astura Medical, LLC Oct 26, 2020 |
| K201811 — coraForce and coraFlex Support Catheters | Reflow Medical, Inc. Oct 26, 2020 |
| K202528 — Cannulated Power Driver Attachment | K2M, Inc. Oct 26, 2020 |
| K200937 — ACURA Stabilization System | Indius Medical Technologies Pvt. , Ltd. Oct 26, 2020 |
| K202179 — Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industries, Inc. Oct 26, 2020 |
| K202489 — AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System | Advanced Orthopaedic Solutions, Inc. Oct 26, 2020 |
| K202469 — G-EYE System | Smart Medical Systems , Ltd. Oct 26, 2020 |
| K201335 — Li-Battery powered OTC TENS/EMS Combination Stimulator | Everyway Medical Instruments Co.,Ltd Oct 24, 2020 |
| K200223 — PocketDoc Micro Wound Therapy System | Pensar Medical, LLC Oct 23, 2020 |
| K202429 — Mobio Total Knee System | B-One Ortho, Corp. Oct 23, 2020 |
| K200249 — Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) | Kitazato Corporation Oct 23, 2020 |
| K193357 — V-Mix | Inter-Med/Vista Dental Products Oct 23, 2020 |
| K201843 — Infrared ear and forehead thermometer, model YI-100 | Wenzhou Yosun Medical Technology Co.,Ltd Oct 23, 2020 |
| K193088 — MaxZero Extension Sets with Needle-Free Connector(s) | Carefusion, Inc. Oct 23, 2020 |
| K202797 — Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. Oct 23, 2020 |
| K202071 — SURGIPHOR Wound Irrigation System | Orthophor, LLC Oct 23, 2020 |
| K192317 — Planmed Clarity 2D and Clarity S | Planmed OY Oct 23, 2020 |
| K200109 — OXY-1 System | Abiomed, Inc. Oct 23, 2020 |
| K202894 — Wiltrom Spinal Fixation System | Wiltrom Corporation Limited Oct 23, 2020 |
| K201824 — Nerivio | Theranica Bio-Electronics, Ltd. Oct 23, 2020 |
| K192811 — BenestaTM Tissue Removal Device | Caldera Medical, Inc. Oct 23, 2020 |
| K202392 — SIR-Spheres Microspheres Activity Calculator (SMAC) | Sirtex Medical US Holdings, Inc. Oct 23, 2020 |
| K193556 — Cryocheck Hex LA | Precision Biologic Oct 23, 2020 |
| K202948 — EzOrtho | Ewoosoft Co., Ltd. Oct 22, 2020 |
| K202428 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. Oct 22, 2020 |
| K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | KARL STORZ Endoscopy-America, Inc. Oct 22, 2020 |
| K201768 — Voluson E10 | GE Healthcare Oct 22, 2020 |
| K202817 — GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC Oct 22, 2020 |
| K202180 — Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 | Axess Vision Technology Oct 22, 2020 |
| K193623 — DIOnavi-Denture | Dio Corporation Oct 22, 2020 |
| K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | Arlington Scientific, Inc. (Asi) Oct 21, 2020 |
| K201688 — S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. Oct 21, 2020 |