| K210785 — Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company Nov 13, 2021 |
| K202671 — DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) | Guangzhou Xinbo Electronic Co., Ltd. Nov 12, 2021 |
| K203184 — HYDRASHIFT 2/4 isatuximab | Sebia Nov 12, 2021 |
| K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Biomerieux S.A. Nov 12, 2021 |
| K212595 — Erchonia FX-405 | Erchonia Corporation Nov 12, 2021 |
| K212259 — Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Zirdent New Material Co., Ltd. Nov 12, 2021 |
| K212621 — MAMMOVISTA B.smart | Siemens Medical Solutions USA, Inc. Nov 12, 2021 |
| K202319 — Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | Tianjin Huahong Technology Co., Ltd. Nov 12, 2021 |
| K210383 — Wrap Accessory Electrodes | Hi-Dow International, Inc. Nov 12, 2021 |
| K212984 — MiPACS HTML5 Web Viewer | Lead Technologies, Inc. Nov 12, 2021 |
| K212448 — NightGuard Flex | Sprintray, Inc. Nov 12, 2021 |
| K211876 — Intellijoint VIEW | Intellijoint Surgical, Inc. Nov 12, 2021 |
| K211359 — Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | Tornier, Inc. Nov 12, 2021 |
| K210989 — Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG Nov 12, 2021 |
| K213364 — EnSite X EP System | ABBOTT MEDICAL Nov 11, 2021 |
| K212532 — Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) | Crdlight Optoelectronic Technology Co., Ltd. Nov 11, 2021 |
| K212497 — Nitrile Examination Glove (Powder free, Blue) | Jiangsu Jinlian Medical Technology Co., Ltd. Nov 11, 2021 |
| K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | Caldera Medical, Inc. Nov 10, 2021 |
| K212659 — More-Cell-System | Agency For Medical Innovations GmbH Nov 10, 2021 |
| K203746 — Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. Nov 10, 2021 |
| K212583 — AlignRT Plus | Vision Rt, Ltd. Nov 10, 2021 |
| K211733 — Lunit INSIGHT CXR Triage | Lunit, Inc. Nov 10, 2021 |
| K210344 — inVisionOS | Precisionos Technology, Inc. Nov 10, 2021 |
| K212284 — Disposable Automatic Core Biopsy Instrument | Suzhou Leapmed Healthcare Corporation Nov 10, 2021 |
| K210779 — Powder Free Nitrile Patient Examination Gloves, Blue Color | Shandong Shangwei Medical Products Co., Ltd. Nov 10, 2021 |
| K212003 — ESSENZ Patient Monitor | Livanova Deutschland, GmbH Nov 10, 2021 |
| K201082 — LTV2 Series Ventilators | Vyaire Medical, Inc. Nov 10, 2021 |
| K212887 — RTapp | Segana, Inc. Nov 10, 2021 |
| K212978 — Diode laser therapy system | Beijing Unt Technology Co., Ltd. Nov 10, 2021 |
| K212107 — Reverso | Intelis Instruments , Ltd. Nov 10, 2021 |
| K213089 — Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | Ivenix, Inc. Nov 10, 2021 |
| K213389 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. Nov 10, 2021 |
| K211244 — VSP® Orthopedics System | 3D Systems Nov 10, 2021 |
| K212013 — eKuore Pro 4T - REF EP0098 | Chip Ideas Electronics S.L. Nov 10, 2021 |
| K212331 — BodySculp | Rohrer Aesthetics, LLC Nov 9, 2021 |
| K211289 — RMU-2000 Automated Chest Compression System | Defibtech, LLC Nov 9, 2021 |
| K211165 — Medical Face Masks, Model Name:MY020003 | Huizhou Jie Bai Purification Co., Ltd. Nov 9, 2021 |
| K213383 — WHILL Model C2 | Whill, Inc. Nov 9, 2021 |
| K211206 — FreedomEdge(R) Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems Nov 9, 2021 |
| K212526 — Surgical Face Mask | Suzhou Janee Medical Technology Co., Ltd. Nov 9, 2021 |
| K211315 — Comby EEG Caps | Pamel D.O.O Nov 9, 2021 |
| K211967 — Sensual Massage, Ultra Pure | Dreambrands, Inc. Nov 9, 2021 |
| K211546 — Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. Nov 9, 2021 |
| K202326 — BESPA Charcot System | Bespa Global, LLC Nov 9, 2021 |
| K211517 — Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories | Convergent Laser Technologies Nov 9, 2021 |
| K212787 — GT5 conductive & abrasive gel | Wuhan Greentek Pty , Ltd. Nov 8, 2021 |
| K212550 — Hura CTP v1.0 | Hura Imaging, Inc. Nov 8, 2021 |
| K211199 — ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. Nov 8, 2021 |
| K212068 — Biotech Dental Kits | Biotech Dental, Sas Nov 8, 2021 |
| K203067 — Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F | Qura S.R.L Nov 8, 2021 |