| K200091 — Capiox iCP Centrifugal Pump | Terumo Cardiovascular Systems Corporation Nov 18, 2021 |
| K211998 — Desnuda Reflect | Good Clean Love, Inc. Nov 18, 2021 |
| K213406 — Savvy Mask - Level 3 Surgical Face Mask | Texas Medplast, LLC Nov 18, 2021 |
| K210350 — Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC Nov 18, 2021 |
| K212112 — Cardiologs Holter Platform | Cardiologs Technologies Nov 18, 2021 |
| K212992 — LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG Nov 18, 2021 |
| K212640 — Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. Nov 18, 2021 |
| K213469 — VALORY | Agfa N.V. Nov 18, 2021 |
| K213251 — HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. Nov 18, 2021 |
| K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical Nov 18, 2021 |
| K212000 — Medley | Good Clean Love, Inc. Nov 18, 2021 |
| K213425 — BruxZir Esthetic | Prismatik Dentalcraft, Inc. Nov 17, 2021 |
| K212456 — Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. Nov 17, 2021 |
| K212444 — Qora Stool Management Kit | Cm Technologies, Inc. Nov 17, 2021 |
| K211678 — Lunit INSIGHT MMG | Lunit, Inc. Nov 17, 2021 |
| K212415 — Arthrex Modular Glenoid System-Titanium Glenosphere | Arthrex, Inc. Nov 17, 2021 |
| K212336 — Soteria.AI | Omega Medical Imaging, LLC Nov 17, 2021 |
| K210042 — Disposable Surgical Mask | Suzhou Letian Protective Products Co., Ltd. Nov 17, 2021 |
| K211538 — Protect X Level 3 Isolation Gown | Azac Group Nov 17, 2021 |
| K211890 — Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. Nov 17, 2021 |
| K213071 — MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. Nov 16, 2021 |
| K212047 — Pantheris System | Avinger, Inc. Nov 16, 2021 |
| K211697 — Esperance Aspiration Catheter System | Wallaby Medical Nov 16, 2021 |
| K212455 — InZone Detachment System | Stryker Neurovascular Nov 16, 2021 |
| K211845 — Deploy Expandable Interbody System | Southern Spine, LLC Nov 16, 2021 |
| K210854 — Enteral Feeding Set | Kb Medical (Group), Inc. Nov 16, 2021 |
| K212029 — Disposable Medical Nitrile Examination Gloves (non-sterile) | Taizhou Kangjian Medical Equipments Co., Ltd. Nov 16, 2021 |
| K212839 — Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. Nov 16, 2021 |
| K212265 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 16, 2021 |
| K212996 — Sterile PHALINX Hammertoe System | Wrightmedicaltechnologyinc Nov 16, 2021 |
| K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | Pall Corporation Nov 16, 2021 |
| K212344 — Surgical Mask | Xiantao Dingcheng Non-Woven Product Co., Ltd. Nov 16, 2021 |
| DEN210014 — EaseVRx | Appliedvr, Inc. Nov 16, 2021 |
| K212607 — Darwin | Luvo Medical Technologies, Inc. Nov 15, 2021 |
| K212731 — Circul8 Pro | Ortho8, Inc. Nov 15, 2021 |
| K213436 — Clarius Ultrasound Scanner | Clarius Mobile Health Corp. Nov 15, 2021 |
| K211329 — Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. Nov 15, 2021 |
| K213497 — ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&Abyz Co., Ltd. Nov 15, 2021 |
| K212695 — KARL STORZ ICG Imaging System | Karl Storz Endoscopy America Nov 15, 2021 |
| K213449 — DS Implants abutments provided with the EV connection | Dentsply Sirona Nov 15, 2021 |
| K211483 — SofWave System | Sofwave Medical, Ltd. Nov 15, 2021 |
| K213000 — Air Compression Massager (Model LF-FT003) | Wenzhou Lingfeng Electronic Technology Co., Ltd. Nov 15, 2021 |
| K212765 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. Nov 15, 2021 |
| K211754 — Vital Signs Monitor | Beijing Choice Electronic Technology Co., Ltd. Nov 15, 2021 |
| K213254 — Axialis Ophthalmic Ultrasound System | Quantel Medical Nov 15, 2021 |
| K212301 — Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Covidien, LLC Nov 15, 2021 |
| K212109 — Spin Care Disposable Protective Mask Level 3 | Spintech, LLC Nov 14, 2021 |
| K212575 — Surgical Face Mask | Hubei Huanfu Plastic Products Co., Ltd. Nov 14, 2021 |
| DEN210006 — Hemolung Respiratory Assist System | Alung Technologies, Inc. Nov 13, 2021 |
| K212264 — Surgical Face mask | Nantong Taiweishi Medical Technology Co., Ltd. Nov 13, 2021 |