| K211941 — 9Line | Energetic Designs, Inc. Jan 27, 2022 |
| K203772 — Omnipod 5 SmartBolus Calculator | Insulet Corporation Jan 27, 2022 |
| K213771 — Merlin Aspiration System | Mivi Neurovascular, Inc. Jan 27, 2022 |
| K211436 — Intermittent Catheter (Not Finalized) | Hollister Incorporated Jan 27, 2022 |
| K203768 — Omnipod 5 ACE Pump (Pod) | Insulet Corporation Jan 27, 2022 |
| K213489 — Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate | Wishbone Medical, Inc. Jan 27, 2022 |
| K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | Carolina Liquid Chemistries Corp. Jan 27, 2022 |
| K211210 — Sterile Auto-Disable Syringes with/without Needle for Single Use | Azur Medical Company, Inc. Jan 27, 2022 |
| K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) | Osteonic Co., Ltd. Jan 27, 2022 |
| K213591 — ANTHEM® Fracture System | Globus Medical, Inc. Jan 26, 2022 |
| K212868 — JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam Jan 26, 2022 |
| K212938 — Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. Jan 26, 2022 |
| K202914 — SternaFuse Fixation System | Fusion Innovations, LLC Jan 26, 2022 |
| K213692 — SmoothSkin Pure Mini | Cyden Limited Jan 26, 2022 |
| K210101 — American-Made Surgical Mask | Armbrust, Inc. Jan 26, 2022 |
| K211219 — LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. Jan 26, 2022 |
| K212610 — Surgical Face Mask | Foshan Nanhai Plus Medical Co, Ltd. Jan 26, 2022 |
| K212771 — LightStim Elipsa | Led Intellectual Properties, LLC Jan 26, 2022 |
| K213347 — ADI Medical Surgical Face Mask | Asia Dynamics Inc., D/B/A Adi Medical Jan 25, 2022 |
| K212173 — HDH Treatment Planning System | Cdb Corporation Jan 25, 2022 |
| K211355 — iCare HOME2 | Icare Finland OY Jan 25, 2022 |
| K201323 — INNO SLA Submerged Implant System | Cowellmedi Co., Ltd. Jan 25, 2022 |
| K213639 — Revaclear 500, Revaclear 400, Revaclear 300 | Baxter Healthcare Corporation Jan 24, 2022 |
| K213780 — DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | Canon, Inc. Jan 24, 2022 |
| K212333 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation Jan 24, 2022 |
| K211482 — Disposable Syringe with Needle | Shandong Qinkai Medical Industry Co., Ltd. Jan 24, 2022 |
| K212111 — Myflon Surgical Mask Level 3 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi Jan 23, 2022 |
| K210810 — Steiking Packaging for Medical Devices | Wipak OY Jan 23, 2022 |
| K210463 — Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Xuzhou Full Sun Medical Products , Ltd. Jan 23, 2022 |
| K213970 — D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply | Danameco Medical Joint Stock Corporation Jan 23, 2022 |
| K213343 — Saremco Print CROWNTEC | Saremco Dental AG Jan 21, 2022 |
| K214030 — Universal DR 1748 | Konica Minolta Healthcare Americas, Inc. Jan 21, 2022 |
| K213673 — b-ONE MOBIO Total Knee System | B-One Ortho, Corp. Jan 21, 2022 |
| K211864 — Powder Free Nitrile Patient Examination Gloves, Blue Color | Siyang Jaysun Medtech Co., Ltd. Jan 21, 2022 |
| K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS | ABBOTT MEDICAL Jan 21, 2022 |
| K211752 — Infrared Thermometer | Beijing Choice Electronic Technology Co., Ltd. Jan 21, 2022 |
| K203761 — ParaMotion | Powerbasetec GmbH Jan 21, 2022 |
| K212991 — Osteorevive | Bone Solutions, Inc. Jan 21, 2022 |
| K213412 — VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM | Steris Corparation Jan 21, 2022 |
| K191105 — e-Throne Folding Wheelchair, Model: ET-12F22 | Golden Motor Technology Co., Ltd. Jan 21, 2022 |
| K213696 — ETHICON Megadyne Electrosurgical Generator | Megadyne Medical Products, Inc. Jan 21, 2022 |
| K213470 — PERLA® TL Posterior Osteosynthesis System | Spineart Jan 21, 2022 |
| K213044 — Nitrile Examination Gloves | Jiangsu Huayuan Medical Technology Co., Ltd. Jan 21, 2022 |
| DEN200059 — POMC/PCSK1/LEPR CDx Panel | Preventiongenetics, LLC Jan 21, 2022 |
| K212594 — OSSIOfiber® Staple | OSSIO , Ltd. Jan 21, 2022 |
| K210259 — Parkell Self-Adhesive Cement | Parkell, Inc. Jan 20, 2022 |
| K213668 — SIGNA Hero | Ge Healthcare (Ge Medical Systems, LLC) Jan 20, 2022 |
| K211333 — KIDNEY ASSIST-transport | Xvivo Perfusion AB Jan 20, 2022 |
| K213709 — SIGNA PET/MR | Ge Medical Systems, LLC Jan 20, 2022 |
| K213075 — Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. Jan 20, 2022 |