| Impertech Surgical Face Mask (K212046) | Impertech Industries , Ltd. | 2021-11-18 |
| MD-320W Ultrasound Biomicroscope (K213070) | MEDA Co., Ltd. | 2021-11-18 |
| DIXI Medical Microdeep Micro-Macro Depth Electrodes (K202087) | Dixi Medical | 2021-11-18 |
| Cardiologs Holter Platform (K212112) | Cardiologs Technologies | 2021-11-18 |
| CoLink Vallux Plating System (K212487) | In2bones USA, LLC | 2021-11-18 |
| Dermalux Flex MD (K212275) | Aesthetic Technology, Ltd. | 2021-11-18 |
| Stratum® Ankle Fusion Plating System (K212640) | Nextremity Solutions, Inc. | 2021-11-18 |
| LINK® Embrace Shoulder System - Reverse Configuration (K212992) | Waldemar Link GmbH & Co. KG | 2021-11-18 |
| Savvy Mask - Level 3 Surgical Face Mask (K213406) | Texas Medplast, LLC | 2021-11-18 |
| HANAROSTENT Esophagus Asymmetric (CCC) (K213251) | M.I.Tech Co., Ltd. | 2021-11-18 |
| Reprocessed IntellaMap Orion High Resolution Mapping Catheter (K211662) | Innovative Health, LLC | 2021-11-18 |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K212456) | Hyperfine, Inc. | 2021-11-17 |
| Arthrex Modular Glenoid System-Titanium Glenosphere (K212415) | Arthrex, Inc. | 2021-11-17 |
| Lunit INSIGHT MMG (K211678) | Lunit, Inc. | 2021-11-17 |
| BruxZir Esthetic (K213425) | Prismatik Dentalcraft, Inc. | 2021-11-17 |
| Qora Stool Management Kit (K212444) | Cm Technologies, Inc. | 2021-11-17 |
| Soteria.AI (K212336) | Omega Medical Imaging, LLC | 2021-11-17 |
| Promisemed Sharps container (K211890) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-11-17 |
| Disposable Surgical Mask (K210042) | Suzhou Letian Protective Products Co., Ltd. | 2021-11-17 |
| Protect X Level 3 Isolation Gown (K211538) | Azac Group | 2021-11-17 |
| Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (K211286) | Pall Corporation | 2021-11-16 |
| EaseVRx (DEN210014) | Appliedvr, Inc. | 2021-11-16 |
| Sterile PHALINX Hammertoe System (K212996) | Wrightmedicaltechnologyinc | 2021-11-16 |
| 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 (K212265) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-16 |
| Pantheris System (K212047) | Avinger, Inc. | 2021-11-16 |
| Opulent TiNbN Coated Knee (K212839) | Meril Healthcare Pvt. , Ltd. | 2021-11-16 |
| MOTOTM Partial Knee & MOTO PFJ Systems Extension (K213071) | Medacta International S.A. | 2021-11-16 |
| InZone Detachment System (K212455) | Stryker Neurovascular | 2021-11-16 |
| Surgical Mask (K212344) | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 2021-11-16 |
| Esperance Aspiration Catheter System (K211697) | Wallaby Medical | 2021-11-16 |
| Deploy Expandable Interbody System (K211845) | Southern Spine, LLC | 2021-11-16 |
| Disposable Medical Nitrile Examination Gloves (non-sterile) (K212029) | Taizhou Kangjian Medical Equipments Co., Ltd. | 2021-11-16 |
| Enteral Feeding Set (K210854) | Kb Medical (Group), Inc. | 2021-11-16 |
| SofWave System (K211483) | Sofwave Medical, Ltd. | 2021-11-15 |
| ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) (K213497) | H&abyz Co., Ltd. | 2021-11-15 |
| Vital Signs Monitor (K211754) | Beijing Choice Electronic Technology Co., Ltd. | 2021-11-15 |
| Clarius Ultrasound Scanner (K213436) | Clarius Mobile Health Corp. | 2021-11-15 |
| Darwin (K212607) | Luvo Medical Technologies, Inc. | 2021-11-15 |
| Air Compression Massager (Model LF-FT003) (K213000) | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 2021-11-15 |
| Axialis Ophthalmic Ultrasound System (K213254) | Quantel Medical | 2021-11-15 |
| Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K212765) | Bloomden Bioceramics (HuNan) Co., Ltd. | 2021-11-15 |
| Circul8 Pro (K212731) | Ortho8, Inc. | 2021-11-15 |
| Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device (K212301) | Covidien, LLC | 2021-11-15 |
| KARL STORZ ICG Imaging System (K212695) | Karl Storz Endoscopy America | 2021-11-15 |
| DS Implants abutments provided with the EV connection (K213449) | Dentsply Sirona | 2021-11-15 |
| Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (K211329) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021-11-15 |
| Spin Care Disposable Protective Mask Level 3 (K212109) | Spintech, LLC | 2021-11-14 |
| Surgical Face Mask (K212575) | Hubei Huanfu Plastic Products Co., Ltd. | 2021-11-14 |
| Disposable Surgical Gowns (K210785) | Chongqing Litai Fashion Group Limited Company | 2021-11-13 |
| Hemolung Respiratory Assist System (DEN210006) | Alung Technologies, Inc. | 2021-11-13 |
| Surgical Face mask (K212264) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021-11-13 |
| MiPACS HTML5 Web Viewer (K212984) | Lead Technologies, Inc. | 2021-11-12 |
| NightGuard Flex (K212448) | Sprintray, Inc. | 2021-11-12 |
| Wrap Accessory Electrodes (K210383) | Hi-Dow International, Inc. | 2021-11-12 |
| 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 (K210989) | Brainlab AG | 2021-11-12 |
| HYDRASHIFT 2/4 isatuximab (K203184) | Sebia | 2021-11-12 |
| Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319) | Tianjin Huahong Technology Co., Ltd. | 2021-11-12 |
| DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) (K202671) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-11-12 |
| ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757) | Biomerieux S.A. | 2021-11-12 |
| Erchonia FX-405 (K212595) | Erchonia Corporation | 2021-11-12 |
| Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation (K211359) | Tornier, Inc. | 2021-11-12 |
| MAMMOVISTA B.smart (K212621) | Siemens Medical Solutions USA, Inc. | 2021-11-12 |
| Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K212259) | Zirdent New Material Co., Ltd. | 2021-11-12 |
| Intellijoint VIEW (K211876) | Intellijoint Surgical, Inc. | 2021-11-12 |
| Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) (K212532) | Crdlight Optoelectronic Technology Co., Ltd. | 2021-11-11 |
| Nitrile Examination Glove (Powder free, Blue) (K212497) | Jiangsu Jinlian Medical Technology Co., Ltd. | 2021-11-11 |
| EnSite X EP System (K213364) | ABBOTT MEDICAL | 2021-11-11 |
| Powder Free Nitrile Patient Examination Gloves, Blue Color (K210779) | Shandong Shangwei Medical Products Co., Ltd. | 2021-11-10 |
| LTV2 Series Ventilators (K201082) | Vyaire Medical, Inc. | 2021-11-10 |
| 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 (K211975) | Caldera Medical, Inc. | 2021-11-10 |
| Venen-trainer (Model: FM150, SFM90) (K203746) | Shenzhen Pango Electronic Co., Ltd. | 2021-11-10 |
| More-Cell-System (K212659) | Agency For Medical Innovations GmbH | 2021-11-10 |
| Lunit INSIGHT CXR Triage (K211733) | Lunit, Inc. | 2021-11-10 |
| Disposable Automatic Core Biopsy Instrument (K212284) | Suzhou Leapmed Healthcare Corporation | 2021-11-10 |
| eKuore Pro 4T - REF EP0098 (K212013) | Chip Ideas Electronics S.L. | 2021-11-10 |
| Reverso (K212107) | Intelis Instruments , Ltd. | 2021-11-10 |
| Diode laser therapy system (K212978) | Beijing Unt Technology Co., Ltd. | 2021-11-10 |
| inVisionOS (K210344) | Precisionos Technology, Inc. | 2021-11-10 |
| VSP® Orthopedics System (K211244) | 3D Systems | 2021-11-10 |
| ESSENZ Patient Monitor (K212003) | Livanova Deutschland, GmbH | 2021-11-10 |
| AlignRT Plus (K212583) | Vision Rt, Ltd. | 2021-11-10 |
| RTapp (K212887) | Segana, Inc. | 2021-11-10 |
| Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector (K213089) | Ivenix, Inc. | 2021-11-10 |
| Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System (K213389) | Conformis, Inc. | 2021-11-10 |
| 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 (K211517) | Convergent Laser Technologies | 2021-11-09 |
| RMU-2000 Automated Chest Compression System (K211289) | Defibtech, LLC | 2021-11-09 |
| BodySculp (K212331) | Rohrer Aesthetics, LLC | 2021-11-09 |
| Medical Face Masks, Model Name:MY020003 (K211165) | Huizhou Jie Bai Purification Co., Ltd. | 2021-11-09 |
| Sensual Massage, Ultra Pure (K211967) | Dreambrands, Inc. | 2021-11-09 |
| WHILL Model C2 (K213383) | Whill, Inc. | 2021-11-09 |
| Surgical Face Mask (K212526) | Suzhou Janee Medical Technology Co., Ltd. | 2021-11-09 |
| FreedomEdge(R) Syringe Infusion System (K211206) | Repro-Medical System, Inc., Dba Koru Medical Systems | 2021-11-09 |
| Comby EEG Caps (K211315) | Pamel D.O.O | 2021-11-09 |
| BESPA Charcot System (K202326) | Bespa Global, LLC | 2021-11-09 |
| Vektor Computational ECG Mapping System (vMap) (K211546) | Vektor Medical, Inc. | 2021-11-09 |
| Paragon 28 External Ring Fixation System (K212895) | Paragon 28, Inc. | 2021-11-08 |
| Hura CTP v1.0 (K212550) | Hura Imaging, Inc. | 2021-11-08 |
| GIQuant (K211356) | Motilent, Ltd. | 2021-11-08 |
| Biotech Dental Kits (K212068) | Biotech Dental, Sas | 2021-11-08 |
| ST AIA-PACK BNP Assay (K211199) | Tosoh Bioscience, Inc. | 2021-11-08 |