| K212556 — mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. Sep 15, 2021 |
| K210085 — HealthCCSng | Zebra Medical Vision, Ltd. Sep 15, 2021 |
| K210118 — INFRARED BODY THERMOMETER (Model: YK-001) | Longnan Renzhong Medical Equipment Co., Ltd. Sep 15, 2021 |
| K202369 — RXS 1000 | Rolence Enterprise, Inc. Sep 15, 2021 |
| K211227 — HTx Disposable Hysteroscope System | Acuvu, Inc. Sep 15, 2021 |
| K211305 — ANNE One | Sibel, Inc. Sep 14, 2021 |
| K211738 — Rotarex Atherectomy System | C.R. Bard, Inc. Sep 14, 2021 |
| K211474 — Kleiner KG2 System | BAAT Medical Products B.V. Sep 14, 2021 |
| K212291 — PHOENIX | Sedecal., Sa. Sep 14, 2021 |
| K202396 — VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) | bioMerieux, Inc. Sep 14, 2021 |
| K212678 — Viveve System, Viveve 2.0 System | Viveve Medical, Inc. Sep 14, 2021 |
| K211494 — Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Sep 14, 2021 |
| K193650 — LIAISON Ferritin | DiaSorin, Inc. Sep 14, 2021 |
| K210184 — Wilson Tech Disposable Medical Face Mask | Wilson Tech (International) Limited Sep 14, 2021 |
| K211464 — Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. Sep 14, 2021 |
| K210586 — Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | Cardiovascular Systems, Inc. Sep 14, 2021 |
| K211283 — Compressible Limb and Circulation Therapy System, Model POWER-Q2300 | Wonjin Mulsan Co., Ltd. Sep 14, 2021 |
| K210461 — End Cap | Medical Components Inc (Medcomp) Sep 14, 2021 |
| K211389 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation | Magstim Company, Ltd. Sep 14, 2021 |
| K210396 — Harmony Referral System | Topcon Healthcare Solutions EMEA Oy Sep 13, 2021 |
| K212685 — KONICAMINOLTA DI-X1 | Konica Minolta, Inc. Sep 13, 2021 |
| K211270 — CIV-Clear cover | CIVCO Medical Instruments Co., Inc. Sep 13, 2021 |
| K202540 — EliA Rib-P | Phadia AB Sep 13, 2021 |
| K203455 — Disposable Medical Mask | Fujian Kang Chen Daily Necessities Co., Ltd. Sep 13, 2021 |
| K212214 — HandX | Human Xtensions , Ltd. Sep 13, 2021 |
| K212412 — IRIS-XP | Medicore Co., Ltd. Sep 13, 2021 |
| K201793 — EDEN Peek Cage | Jmt Co., Ltd. Sep 13, 2021 |
| K202541 — EliA RNA Pol III | Phadia AB Sep 13, 2021 |
| K211296 — Surgical face mask | Sunsmed Protective Products , Ltd. Sep 11, 2021 |
| K211828 — Aquilion Exceed LB | Canon Medical Systems Corporation Sep 10, 2021 |
| K210227 — Sterile syringe for single use with/without needle | Zhejiang Kangkang Medical-Devices Co., Ltd. Sep 10, 2021 |
| K210410 — s-Clean Pre-Milled Abutment Mini | Dentis Co., Ltd. Sep 10, 2021 |
| K202056 — Kinepict Medical Imaging Tool 4.0 | Kinepict Health, Ltd. Sep 10, 2021 |
| K211856 — gammaCore Sapphire | Electrocore, Inc. Sep 10, 2021 |
| K210093 — AccuFFRangio | ArteryFlow Technology Co., Ltd. Sep 10, 2021 |
| K211488 — LOGIQ E10 | GE Healthcare Sep 10, 2021 |
| K210160 — AlertWatch:AC | Alertwatch, Inc. Sep 10, 2021 |
| K211334 — Iovera System | Pacira Pharmaceuticals, Inc. Sep 10, 2021 |
| K212451 — Surgical Mask | Remade USA, LLC Sep 10, 2021 |
| K211257 — EFAI PACS Picture Archiving and Communication System | Ever Fortune.Ai, Co., Ltd. Sep 10, 2021 |
| K212540 — Explorer TO System | SeaSpine Orthopedics Corporation Sep 10, 2021 |
| K211375 — Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Sep 10, 2021 |
| K203785 — ClariSIGMAM | Claripi, Inc. Sep 10, 2021 |
| K210438 — Versana Premier | GE Medical Systems Ultrasound And Primary Care Diagnostics Sep 10, 2021 |
| K210625 — JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve | Fujifilm Medwork GmbH Sep 10, 2021 |
| K212553 — DIGITAL RADIOGRAPHY CXDI-Pro, D1 | Canon, Inc. Sep 9, 2021 |
| K212246 — Exofin Precision Pen | Chemence Medical, Inc. Sep 9, 2021 |
| K211242 — Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes | Promisemed Hangzhou Meditech Co., Ltd. Sep 9, 2021 |
| K211824 — HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Sep 9, 2021 |
| K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. Sep 9, 2021 |