| K200545 — Legend Pro DMA | Pollogen, Ltd. Oct 21, 2021 |
| K211415 — GR Splint Resin System | Pro3Dure Medical GmbH Oct 21, 2021 |
| K211921 — S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. Oct 20, 2021 |
| K210789 — EQ-PEX | Meta Systems Co., Ltd. Oct 20, 2021 |
| K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. Oct 20, 2021 |
| K210618 — Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series | Chongqing Jinshan Science & Technology Co., Ltd. Oct 20, 2021 |
| K203808 — Multi-unit Abutment, Multi-unit Angled Abutment | Megagen Implant Co., Ltd. Oct 20, 2021 |
| K210177 — PENTAX Medical Video Upper GI Scopes EG17-J10 | Pentax Of America, Inc. Oct 20, 2021 |
| K211672 — MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | Liofilchem S.R.L. Oct 20, 2021 |
| K212490 — AVVIGO Guidance System II | Boston Scientific Corporation Oct 20, 2021 |
| K212470 — iRAD | Claritas Healthtech Pte, Ltd. Oct 20, 2021 |
| K210511 — InTray GC | Biomed Diagnostics Incorporated Oct 20, 2021 |
| K200865 — Piccolo Potassium Test System | Abaxis, Inc. Oct 20, 2021 |
| DEN210005 — Luminopia One | Luminopia, Inc. Oct 20, 2021 |
| K210632 — Contour ProtegeAI | Mim Software, Inc. Oct 20, 2021 |
| K210124 — Synergy Gold (SG) Portable (Models MM011450 and MM011460) | Uzinmedicare Co. Oct 19, 2021 |
| K210911 — WOLF Thrombectomy System, 14F | Devoro Medical, Inc. Oct 19, 2021 |
| K210204 — Capsule Vitals Plus Patient Monitoring System | Capsule Technologie Sas Oct 19, 2021 |
| K212254 — DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Hdx Will Corp. Oct 19, 2021 |
| K211035 — U9000 Plus Ultrafilter | Baxter Healthcare Corporation Oct 19, 2021 |
| K192746 — MyoWorx TM20 | Myoworx, Inc. Oct 19, 2021 |
| K211170 — Single Use Irrigation bipolar cable | Modern Medical Equipment Manufacturing, Ltd. Oct 19, 2021 |
| K211564 — Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. Oct 19, 2021 |
| K212703 — AcuPulse CO2 Laser System, Delivery Devices and Accessories | Lumenis, Ltd. Oct 19, 2021 |
| K203565 — Surgical 3D Mask | Inno Lifecare Oct 19, 2021 |
| K210706 — Nitrile Examination Gloves | Niujian Technology Co., Ltd. Oct 19, 2021 |
| K201773 — PICOHI | Hironic Co., Ltd. Oct 19, 2021 |
| K211084 — Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | Shanghai Caremate Medical Device Co., Ltd. Oct 19, 2021 |
| K202982 — Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) | Winner Medical Co., Ltd. Oct 19, 2021 |
| K211555 — Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Oct 18, 2021 |
| K212753 — 0909FCB, 1212FCA | Rayence Co., Ltd. Oct 18, 2021 |
| K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle | Hitachi Chemical Diagnostics, Inc. Oct 18, 2021 |
| K211582 — LOQTEQ Proximal Humerus Plate 3.5 System | Aap Implantate AG Oct 18, 2021 |
| K212528 — Change Healthcare Cardiology | Change Healthcare Israel , Ltd. Oct 18, 2021 |
| K211809 — Surgical Gown | Wuhan Dymex Healthcare Co., Ltd. Oct 18, 2021 |
| K212632 — ClotTriever Thrombectomy System | Inari Medical, Inc. Oct 18, 2021 |
| K201017 — BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Geneohm Sciences Canada, Inc. (Bd Life Sciences) Oct 18, 2021 |
| K211992 — Ortho MI System | Osteonic Co., Ltd. Oct 15, 2021 |
| K201880 — MultiSure GK Link Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. Oct 15, 2021 |
| K211224 — RM4 Control Unit | Institut Georges Lopez Oct 15, 2021 |
| K212593 — ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. Oct 15, 2021 |
| K212959 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. Oct 15, 2021 |
| K212967 — AxTiHA Stand-Alone ALIF System | Innovasis, Inc. Oct 15, 2021 |
| K212636 — CORUS Spinal System-X | Providence Medical Technology, Inc. Oct 15, 2021 |
| K210563 — Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. Oct 15, 2021 |
| K211403 — HIVOX OTC Electrical Stimulator, FT610-B | Hivox Biotek, Inc. Oct 15, 2021 |
| K202433 — Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC Oct 15, 2021 |
| K212517 — Magicore System | Innobiosurg Co., Ltd. Oct 15, 2021 |
| K211091 — Deka Tiac II | El.En Electronic Engineering Spa Oct 15, 2021 |
| K212261 — StrokeSENS LVO | Circle Neurovascular Imaging, Inc. Oct 14, 2021 |