| K202391 — DIR 800 | Aesculap, Inc. Jan 21, 2021 |
| K203189 — AEROCURE-MD | Aerobiotix, Inc. Jan 21, 2021 |
| K202839 — Overlapped Compression Therapy | Jkh Health Co., Ltd. Jan 21, 2021 |
| K202408 — cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. Jan 21, 2021 |
| K202629 — Dentsply Sirona Universal Spray Glazes | Dentsply Sirona Jan 20, 2021 |
| K201685 — Potenza | Jeisys Medical, Inc. Jan 19, 2021 |
| K192913 — R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS Jan 19, 2021 |
| K203719 — IntraSight Mobile | Volcano Corporation Jan 19, 2021 |
| K203485 — SnugFit All-Suture Anchor | Medacta International S.A. Jan 19, 2021 |
| K202363 — HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. Jan 19, 2021 |
| K203153 — CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | Globus Medical, Inc. Jan 19, 2021 |
| K203726 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. Jan 19, 2021 |
| K200163 — Ava Fertility Tracker | Ava AG Jan 19, 2021 |
| K202833 — Sequel External Fixation Device | Sequel Medical, Inc. Jan 19, 2021 |
| K201219 — Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC Jan 19, 2021 |
| K201930 — Nanum Syringe | Nanum Company Co., Ltd. Jan 17, 2021 |
| K200565 — Galapogos | Resmed Corp Jan 17, 2021 |
| K203683 — CarboClear Lumbar Cage System | Carbofix Orthpedics , Ltd. Jan 15, 2021 |
| K203209 — AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. Jan 15, 2021 |
| K202653 — Gymform Total ABS | Well Brain International , Ltd. Jan 15, 2021 |
| K202826 — IMMULITE® 2000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. Jan 15, 2021 |
| K203308 — Ali Interbody Fusion System | Raed M. Ali, M.D., Inc. Jan 15, 2021 |
| K193608 — EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG Jan 15, 2021 |
| K203381 — Dynanail Mini Hybrid | MedShape, Inc. Jan 15, 2021 |
| K202107 — Medical Protective Mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. Jan 15, 2021 |
| K201579 — Infrared Thermometer | Shenzhen Xunwei Industrial Co., Ltd. Jan 15, 2021 |
| K203270 — IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. Jan 15, 2021 |
| K202847 — AccuBrain | Brainnow Medical Technology Limited Jan 15, 2021 |
| K203678 — CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. Jan 15, 2021 |
| K202141 — Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | Argon Medical Devices, Inc. Jan 15, 2021 |
| K203142 — Veuron-Brain-pAb | Heuron Co., Ltd. Jan 15, 2021 |
| K201582 — Non-contact Electronic Forehead Infrared Thermometer | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. Jan 15, 2021 |
| K203677 — ViewPoint 6 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Jan 15, 2021 |
| K201650 — VMCore Biopsy Needle | Uro-1, Inc. Jan 15, 2021 |
| K201897 — Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 | Richard Wolf Medical Instruments Corporation Jan 15, 2021 |
| K201085 — NeVa PV Thrombectomy Device | Vesalio Jan 15, 2021 |
| K203506 — PERLA® TL posterior osteosynthesis system | Spineart Jan 15, 2021 |
| K202767 — Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation Jan 15, 2021 |
| K193271 — uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. Jan 15, 2021 |
| K202019 — Maven Patient-Specific Instrumentation | Paragon 28, Inc. Jan 14, 2021 |
| K202700 — ART-Plan | Therapanacea Jan 14, 2021 |
| K203669 — Mobius3D | Varian Medical Systems, Inc. Jan 14, 2021 |
| K201719 — Vital Sleep | The Snore Reliever Company, LLC Jan 14, 2021 |
| K201922 — Trophikos Vaginal Moisturizer | Trophikos, LLC Jan 14, 2021 |
| K202104 — BioGuard EUS Air/Water and Suction Valves | STERIS Corporation Jan 14, 2021 |
| K202333 — Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. Jan 14, 2021 |
| K203241 — OmniGuide BeamPath OTO-U Fiber | Omniguide, Inc. Jan 14, 2021 |
| K200702 — EasyPath RF Introducer Sheath | Broncus Medical, Inc. Jan 14, 2021 |
| K202769 — VELYS Robotic-Assisted Solution | Depuy Ireland UC Jan 14, 2021 |
| K202694 — Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family) | Vycor Medical, Inc. Jan 14, 2021 |