| K211316 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Jul 23, 2021 |
| K211951 — GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. Jul 23, 2021 |
| K210159 — IntraLock System | Fusion Orthopedics, LLC Jul 23, 2021 |
| K202727 — Peregrine Endoscopy System | 3Nt Medical , Ltd. Jul 23, 2021 |
| K201160 — HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. Jul 23, 2021 |
| K211012 — Nitrile Patient Examination Gloves | Huayuan Medical Technology(Shangqiu) Co., Ltd. Jul 23, 2021 |
| K201887 — VS Newborn Heart Rate Monitor | Surepulse Medical Limited Jul 23, 2021 |
| K211249 — Altor Safety 3-Ply Surgical Mask (Model:62222) | Altor Safety, LLC Jul 23, 2021 |
| K211602 — Klassic Knee System | Total Joint Orthopedics, Inc. Jul 23, 2021 |
| K210468 — SC1 Handheld Ultrasound Imaging System (Model: SC1) | Fcu Co., Ltd. Jul 23, 2021 |
| K210382 — Blustone Synergy Diamond SA Cervical System | Blustone Synergy, LLC Jul 23, 2021 |
| K202612 — Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) | Thermo Fisher Scientific Jul 23, 2021 |
| K202582 — Arthrex SynergyID Endoscopic Imaging System | Arthrex, Inc. Jul 22, 2021 |
| K211968 — NIO+ Adult | Waismed, Ltd. Jul 22, 2021 |
| K210143 — Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) | Foshan Nanhai Plus Medical Co, Ltd. Jul 22, 2021 |
| K210579 — WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System | OTU Medical, Inc. Jul 22, 2021 |
| K212008 — Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. Jul 22, 2021 |
| K203694 — DELTA XTEND Reverse Shoulder System | Depuy Ireland UC Jul 22, 2021 |
| K210176 — FlowSaver Blood Filter | Inari Medical Jul 22, 2021 |
| K211944 — Medline UNITE® Digital Fusion Screw System | Medline Industries, Inc. Jul 22, 2021 |
| K211633 — Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Jul 22, 2021 |
| K211688 — DC-Air and Athlos-1 and Athlos-Air | Athlos OY Jul 22, 2021 |
| K202603 — Temp Pal | Iweecare Co., Ltd. Jul 22, 2021 |
| K203214 — DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. Jul 22, 2021 |
| K203175 — POLARSTEM Cemented Femoral Stem | Smith & Nephew, Inc. Jul 22, 2021 |
| K211220 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs | Guangdong Kingfa Sci. & Tech.Co., Ltd. Jul 22, 2021 |
| K203411 — syngo.CT Skull Unfolding | Siemens Medical Solutions USA, Inc. Jul 22, 2021 |
| K210391 — Single-use medical face mask | Zhuhai Herald Datanetics Limited. Jul 22, 2021 |
| K211939 — ExacTrac Dynamic | Brainlab AG Jul 22, 2021 |
| K210415 — QSM software, QSMetric | Medimagemetric, LLC Jul 22, 2021 |
| K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation Jul 21, 2021 |
| K203534 — Surgical face mask (Model: Flat Ear Loop/CN102) | Crown Name Disposable Hygiene Products Fty., Ltd. Jul 21, 2021 |
| K211901 — MolecuLightDX | MolecuLight, Inc. Jul 21, 2021 |
| K210686 — Nitrile Patient Examination Glove | Yunnan Huazhiyuan Medical Technology Co., Ltd. Jul 21, 2021 |
| K210970 — Single-Use Surgical Mask Model FE2311B | Byd Precison Manufacturer Co., Ltd. Jul 21, 2021 |
| K203271 — Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. Jul 21, 2021 |
| K210688 — AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | O&M Halyard, Inc. Jul 21, 2021 |
| K201009 — CHIRAVAC Blood Collection Needles | Chirana T. Injecta Jul 21, 2021 |
| K211958 — CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. Jul 21, 2021 |
| K193352 — AbutmentCAD | Exocad GmbH Jul 21, 2021 |
| K210059 — Promisemed Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. Jul 21, 2021 |
| K202868 — LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. Jul 21, 2021 |
| K211906 — Vital Signs | Oxehealth Limited Jul 20, 2021 |
| K203712 — The Slide | Biotex, Inc. Jul 20, 2021 |
| K210129 — RF Thermal System | Luvo Medical Technologies, Inc. Jul 20, 2021 |
| K210684 — Disposable Nitrile Medical Examination Glove | Jiangsu Cureguard Glove Co., Ltd. Jul 20, 2021 |
| K211192 — Grivamax Family of Lasers, Models 272 and 148 | Leana Orders, Inc. Jul 20, 2021 |
| K211859 — ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Jul 20, 2021 |
| K210719 — Change Healthcare Anatomical AI | Change Healthcare Canada Company Jul 20, 2021 |
| K211302 — Elecsys Syphilis | Roche Diagnostics Jul 20, 2021 |