| K213407 — UltiCare Disposable Pen Needles | Ultimed Incorporated Dec 16, 2021 |
| K212055 — Connected OR Hub with Device and Voice Control | Stryker Corporation Dec 16, 2021 |
| K211277 — Theia NPWT Foam Wound Dressing Kit | Clear Choice Therapeutics, Inc. Dec 16, 2021 |
| K212616 — Koios DS | Koios Medical, Inc. Dec 16, 2021 |
| K213092 — Cellusheet, Cellufil | Human Biosciences, Inc. Dec 15, 2021 |
| K212919 — Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Jiujiang Taixin Technology Co., Ltd. Dec 15, 2021 |
| K213443 — Insignia Anterior Cervical Plate System | Alphatec Spine, Inc. Dec 15, 2021 |
| K212861 — Surgical Gown, Reinforced Surgical Gown | Wuhan Zonsen Medical Products Co., Ltd. Dec 15, 2021 |
| K211803 — HealthPPT | Zebra Medical Vision, Ltd. Dec 15, 2021 |
| K213631 — Chocolate PTA Balloon Catheter | Medtronic, Inc. Dec 15, 2021 |
| K212817 — Merit Siege Vascular Plug | Merit Medical System, Inc. Dec 15, 2021 |
| K211539 — Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL | Thermo Fisher Scientific Dec 15, 2021 |
| K200176 — FREEDOM Integrated Syringe Infusion System | Repro-Med Systems, Inc. Dba Koru Medical Systems Dec 15, 2021 |
| K212903 — SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. Dec 15, 2021 |
| K211114 — Will3D | Hdx Will Corp. Dec 15, 2021 |
| K202823 — Innomed NPWT Silicone Foam Dressing | Zhejiang Longterm Medical Technology Co., Ltd. Dec 15, 2021 |
| K213155 — RT-Mind-AI | Medmind Technology Co., Ltd. Dec 15, 2021 |
| K211039 — BIT-Motion | Dde Mri Solutions, Ltd. Dec 15, 2021 |
| K212398 — Surgical Face Mask (Non-sterile) | Hubei Kimsoul Industrial Co., Ltd. Dec 15, 2021 |
| K210405 — ProTEC-USA EZDoff Gown | Cadillac Products, Inc. Dec 15, 2021 |
| K212944 — Disposable Surgical Mask | Heilongjiang Yinjia Medical Equipment Co., Ltd. Dec 15, 2021 |
| K210223 — Transcutaneous Electrical Nerve Stimulator | Top-Rank Health Care Co., Ltd. Dec 15, 2021 |
| K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Corporation Dec 15, 2021 |
| K210965 — reVive Light Therapy Essentials | Led Technologies, Inc. Dec 15, 2021 |
| K212781 — Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity, LLC Dec 15, 2021 |
| K213728 — Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC Dec 15, 2021 |
| K212351 — Revolution Peripheral Atherectomy System | Rex Medical, L.P. Dec 15, 2021 |
| K202822 — Helianthus | Metaltronica Spa Dec 15, 2021 |
| K212675 — Aspira Peritoneal Drainage System | Merit Medical Systems, Inc. Dec 14, 2021 |
| K203716 — PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | Smith And Nephew Medical Limited Dec 14, 2021 |
| K200932 — Blood Collection Needles | Vacutest Kima Srl Dec 14, 2021 |
| K210827 — ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. Dec 14, 2021 |
| K213029 — Nitrile Examination Gloves (Powder free, Blue) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Dec 14, 2021 |
| K212958 — MRIdian Linac System | Viewray, Incorporated Dec 14, 2021 |
| K212538 — DESS Dental Implants | Terrats Medical SL Dec 14, 2021 |
| K212904 — SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation Dec 14, 2021 |
| K202848 — S2 Pigment Removal System | Lightsense Technologies, Ltd. Dec 14, 2021 |
| K212574 — Surgical Face Mask | Xiantao Deming Healthcare Products Co., Ltd. Dec 14, 2021 |
| K212832 — TimeWaver Frequency | Timewaver Production GmbH Dec 14, 2021 |
| K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation Dec 14, 2021 |
| K210481 — Instant 20s Indicator | True Indicating, LLC Dec 14, 2021 |
| K210744 — Surgical Mask | Chongqing PA Xijia Biotechnology Co., Ltd. Dec 14, 2021 |
| K213069 — CoLink NeoFuse Plating System | In2Bones USA, LLC Dec 13, 2021 |
| K212869 — Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. Dec 13, 2021 |
| K212925 — Disposable Surgical Gown | Henan Robestain Medical Products Co., Ltd. Dec 13, 2021 |
| K211572 — Aesculap Slim Clip Applier | Aesculap, Inc. Dec 13, 2021 |
| K212924 — Nitrile Examination Gloves | Shanxi Nacosa Medical Technology Co.,Ltd Dec 13, 2021 |
| K212186 — Philips Radiology Smart Assistant | Philips Medical Systems Dmc GmbH Dec 13, 2021 |
| K213176 — Disposable Nitrile Powder-Free Examination Gloves | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. Dec 13, 2021 |
| K212060 — neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. Dec 13, 2021 |