| K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin | Medicon Hellas S.A Sep 21, 2021 |
| K212837 — ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH Sep 21, 2021 |
| K212655 — Flyte | Pelvital USA, Inc. Sep 21, 2021 |
| K212334 — GEO Extremity and Ankle Plating System | Gramercy Extremity Orthopedics, LLC Sep 21, 2021 |
| K212303 — T2 | Osstem Implant Co., Ltd. Sep 21, 2021 |
| K211073 — Disposable Nitrile Examination Gloves | Foshan Kangkang Biotechnology Co., Ltd. Sep 21, 2021 |
| K201441 — Elecsys Troponin T Gen 5 | Roche Diagnostics Sep 21, 2021 |
| K211931 — Medline Digital Thermometer Non-Lubricated Probe Sheath | Medline Industries, Inc. Sep 20, 2021 |
| K211477 — Latex Examination Powder Free Gloves | Aspen Glove Sdn. Bhd. Sep 20, 2021 |
| K212961 — SMILERS | Biotech Dental Smilers, Sas Sep 20, 2021 |
| K201789 — CT-STOR | Energy Delivery Solutions Sep 20, 2021 |
| K203799 — ProFlex CO2 Laser Fiber | Innovaquartz, LLC Sep 20, 2021 |
| K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. Sep 20, 2021 |
| K211922 — IPL Home Use Hair Removal Device | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. Sep 20, 2021 |
| K210440 — Disposable Sampler Inactivated Transport Media, Nest ITM | Wuxi Nest Biotechnology Co., Ltd. Sep 20, 2021 |
| K212224 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | Imperative Care, Inc. Sep 20, 2021 |
| K202790 — Syntec Orthodontic Mini Screw Extended System | Syntec Scientific Corporation Sep 17, 2021 |
| K211904 — Vinyl Glove | Jiangsu Dihong Industry And Trade Co., Ltd. Sep 17, 2021 |
| K212269 — Intelligent NR | Canon, Inc. Sep 17, 2021 |
| K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. Sep 17, 2021 |
| K210399 — Unifine SafeControl | Owen Mumford, Ltd. Sep 17, 2021 |
| K211234 — RedEx | Advanced Surgical Concepts, Ltd. Sep 17, 2021 |
| K212272 — Tempo Natural Tampon | Dong-A Pharmaceutical Co., Ltd. Sep 17, 2021 |
| K203845 — Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. Sep 17, 2021 |
| K212067 — Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation Sep 17, 2021 |
| K203155 — BreatheSuite MDI V1 | Breathesuite, Inc. Sep 17, 2021 |
| K203141 — Uramix CuraWay Biopsy Needle | Uramix, Inc. Sep 17, 2021 |
| K203418 — Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) | Ningbo Ouhan Medical Device Co., Ltd. Sep 17, 2021 |
| K203762 — Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | Covidien Sep 17, 2021 |
| K211158 — NTI ClenchGuard | Boyd Research, Inc. Sep 17, 2021 |
| K211751 — WELLTRUST WT-III Mask with Flat Earloop | Lonestar Meadows, LLC Sep 17, 2021 |
| K210441 — Incontinence Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. Sep 17, 2021 |
| K211478 — Sterile Latex Surgical Gloves Powder Free | Aspen Glove Sdn. Bhd. Sep 16, 2021 |
| K211479 — Blue Nitrile Examination Glove Powder Free | Aspen Glove Sdn. Bhd. Sep 16, 2021 |
| K212283 — BioRoot Flow 0.5g, BioRoot Flow 2g | Septodont Sep 16, 2021 |
| K212604 — Symbia VA10A Family | Siemens Medical Solutions USA, Inc. Sep 16, 2021 |
| K211512 — VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. Sep 16, 2021 |
| K203112 — Disposable Medical Mask | Yangzhou Runyi Arts & Crafts Co., Ltd. Sep 16, 2021 |
| K212742 — GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating | Waldemar Link GmbH & Co. KG Sep 16, 2021 |
| K212021 — 6430 MyLabX75, 6430 MyLab XPro75 | Esaote, S.P.A. Sep 16, 2021 |
| K203111 — Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Medtronic Sep 16, 2021 |
| K212641 — StrataMR II Valves and Shunts | Medtronic Neurosurgery Sep 16, 2021 |
| K210818 — TrueCare Biomedix Tamper Evident Cap | Us Infusion Inc. D/B/A Truecare Biomedix-USA Sep 15, 2021 |
| K212606 — BeamSite | Doseoptics, LLC Sep 15, 2021 |
| K212009 — Disposable Nitrile Gloves | Jiangsu Shenglijie Safety Products Co., Ltd. Sep 15, 2021 |
| K203492 — Instrument tray, for semi-rigid ureteroscope | Olympus Winter & Ibe GmbH Sep 15, 2021 |
| K202885 — GlucoSure HT Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. Sep 15, 2021 |
| K203649 — TruAbutment DS, TruBase | Truabutment, Inc. Sep 15, 2021 |
| K211276 — Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC Sep 15, 2021 |
| K212710 — GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC Sep 15, 2021 |