| K211588 — Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical Aug 13, 2021 |
| K211563 — Pitch-Patchs | Xiros, Ltd. Aug 13, 2021 |
| K211860 — Powder Free Nitrile Patient Examination Gloves, Blue Color | Anhui Powerguard Technology Co., Ltd. Aug 13, 2021 |
| K212206 — Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) Aug 13, 2021 |
| K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Aug 13, 2021 |
| K192823 — MEGA-TMS | Soterix Medical, Inc. Aug 13, 2021 |
| K210336 — Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Aug 13, 2021 |
| K211969 — EMM Ultrasonic Transducer Cover | Exact Medical Manufacturing Aug 13, 2021 |
| K212229 — White Endoseal MTA | Maruchi Aug 13, 2021 |
| K212228 — WATCHMAN FXD Curve Access System | Boston Scientific Corporation Aug 13, 2021 |
| K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation Aug 13, 2021 |
| K211519 — Every Cycle Reusable Tampon Applicator | Cycle, LLC Aug 13, 2021 |
| K203363 — Crosser iQ CTO Recanalization System | C.R. Bard, Inc. Aug 12, 2021 |
| K210661 — SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset | Quanta Dialysis Technologies, Ltd. Aug 12, 2021 |
| K212007 — VERTICALE Navigation Instruments | Silony Medical GmbH Aug 12, 2021 |
| K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. Aug 12, 2021 |
| K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup | W.H.P.M., Inc. Aug 12, 2021 |
| K211863 — eVolve PACS | Evolve Pacs, Inc. Aug 12, 2021 |
| K211179 — InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. Aug 12, 2021 |
| K211205 — Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. Aug 12, 2021 |
| K210912 — Excelsius3D | Globus Medical, Inc. Aug 12, 2021 |
| K210510 — Disposable Surgical Gown | Shandong Zhushi Pharmaceutical Group Co., Ltd. Aug 12, 2021 |
| K210946 — Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. Aug 12, 2021 |
| K211883 — QUANTUM® Patient Specific Instrumentation (PSI) System | In2Bones Sas Aug 11, 2021 |
| K210759 — Solo, Swing Maxi | Medela, LLC Aug 11, 2021 |
| K203448 — uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. Aug 11, 2021 |
| K211552 — Surgical mask | Shandong Shengquan New Materials Co., Ltd. Aug 11, 2021 |
| K202536 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | Yty Industry (Manjung) Sdn Bhd Aug 11, 2021 |
| K212204 — Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | Cd Diagnostics, Inc. Aug 11, 2021 |
| K211993 — Z-LINKPC System | Zavation Medical Products, LLC Aug 11, 2021 |
| K203643 — Sensatronic Reusable Temperature Probes | Sensatronic GmbH Aug 11, 2021 |
| K211102 — FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. Aug 11, 2021 |
| K210687 — CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care Aug 11, 2021 |
| K203152 — Disposable Face Mask | Chaozhou Cecilia Technology Co., Ltd. Aug 11, 2021 |
| K211353 — Medical Face Mask | Shenzhen Lyttop Healthcare Limited Aug 11, 2021 |
| K211873 — PSX Interbody System | Alphatec Spine, Inc. Aug 10, 2021 |
| K211640 — Ponto 5 Mini | Oticon Medical AB Aug 10, 2021 |
| K210730 — Nitrile Patient Examination Glove | American Performance Polymers, LLC Aug 10, 2021 |
| K210820 — EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica Aug 10, 2021 |
| K211799 — Biodentine XP 500, Biodentine XP 200 | Septodont Aug 10, 2021 |
| K211414 — KHEIRON Spinal Fixation System | S.M.A.I.O Aug 10, 2021 |
| K201026 — sOLVe Tube | Hytek Medical, Inc. Aug 10, 2021 |
| K211300 — X-CUBE 90 | Alpinion Medical Systems Co., Ltd. Aug 9, 2021 |
| K211299 — X-CUBE 70 | Alpinion Medical Systems Co., Ltd. Aug 9, 2021 |
| K211540 — Edma Synthetic Nitrile Examination Gloves | Edma Group, LLC Aug 9, 2021 |
| K211030 — EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | Boston Scientific Corporation Aug 9, 2021 |
| K211354 — Disposable Synthetic Vinyl Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. Aug 8, 2021 |
| K211202 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Stryker Aug 6, 2021 |
| K212100 — Kosmos | EchoNous, Inc. Aug 6, 2021 |
| K200193 — Kisses Plus Implant System | Achimhai Medical Corporation Aug 6, 2021 |