| K210254 — MeMed BV | MeMed Diagnostics, Ltd. Sep 1, 2021 |
| K211823 — Bonine Acupressure Bands | Wellspring Pharmaceutical Corporation Sep 1, 2021 |
| K210032 — Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) | Leadtek Research, Inc. Sep 1, 2021 |
| K211673 — Disposable Medical Nitrile Gloves | Changzhou Yihua Sanitation Material Co., Ltd. Sep 1, 2021 |
| K211174 — IPL Hair Removal | Shenzhen Qiaochengli Technology Co., Ltd. Sep 1, 2021 |
| K201258 — EASYMAX Tag Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. Sep 1, 2021 |
| K211972 — Omeza Collagen Matrix | Omeza, LLC Sep 1, 2021 |
| K210951 — Leonardo Mini Blue | Ceramoptec GmbH Sep 1, 2021 |
| K212139 — Admiral ACP System | SeaSpine Orthopedics Corporation Sep 1, 2021 |
| K203014 — EndoLIF Delta-Cage and DoubleWedge-Cage | Joimax GmbH Sep 1, 2021 |
| K203625 — Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. Sep 1, 2021 |
| K202395 — SP-1000, SP-2000 | Daesung Maref Co., Ltd. Sep 1, 2021 |
| K202204 — Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. Sep 1, 2021 |
| K211536 — Welspun Health Surgical Mask | Welspun India Limited Sep 1, 2021 |
| K211367 — Evo sEEG System | Neuroone Medical Technologies Corp. Sep 1, 2021 |
| K212145 — DR 800 with DSA, DR 800 | Agfa N.V. Aug 31, 2021 |
| K212383 — EndoNaut | Therenva Sas Aug 31, 2021 |
| K203084 — Ablamap Software | Ablacon, Inc. Aug 31, 2021 |
| K211449 — Triton Sacroiliac Joint Fixation System | Choice Spine, LLC Aug 31, 2021 |
| K210956 — Kubtec Mozart (XPERT42) | Kub Technologies, Inc. Aug 31, 2021 |
| K201560 — Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. Aug 31, 2021 |
| K210448 — Adhesive Electrode | Shaoxing Yingtuo Healthcare Co., Ltd. Aug 31, 2021 |
| K212083 — Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. Aug 31, 2021 |
| K203636 — PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG | Jkh USA, LLC Aug 31, 2021 |
| K211704 — CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System | Orthofix, Inc. Aug 31, 2021 |
| K210957 — Kubec Xpert 80 Radiography System | Kub Technologies, Inc. Aug 31, 2021 |
| K211322 — Paratrooper Plantar Plate Repair System | Paragon 28, Inc. Aug 30, 2021 |
| K212054 — Senhance Surgical System | Asensus Surgical, Inc. Aug 30, 2021 |
| K210805 — Ceribell Instant EEG Headband | Ceribell, Inc. Aug 30, 2021 |
| K211903 — Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation Aug 30, 2021 |
| K210090 — Impulse AM Interbody Fusion System | Degen Medical Aug 30, 2021 |
| K211630 — VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) | bioMerieux, Inc. Aug 30, 2021 |
| K211041 — Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 | Shenzhen Yuezhongxing Technology Co., Ltd. Aug 30, 2021 |
| K212103 — StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | Fona S.R.L Aug 30, 2021 |
| K212070 — KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. Aug 30, 2021 |
| K211255 — Surgical Mask | Tianchang Kanghui Protective Products Co, Ltd. Aug 28, 2021 |
| K203554 — AnyOne External Implant System | Megagen Implant Co., Ltd. Aug 28, 2021 |
| K211390 — Nitrile Blue Powder-free Examination Glove | Cardinal Health200, LLC Aug 28, 2021 |
| K212023 — Virage Navigation System | Zimmer Biomet Spine, Inc. Aug 27, 2021 |
| K203613 — ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd Aug 27, 2021 |
| K211995 — Sonendo Filling Material 5C | Sonendo, Inc. Aug 27, 2021 |
| K202781 — Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. Aug 27, 2021 |
| K211413 — BEE PLIF Cage | NGMedical GmbH Aug 27, 2021 |
| K203251 — SOLOPASS System | Intravent Medical Partners, LP Aug 27, 2021 |
| K210530 — WOLF Thrombectomy System, 6F | Devoro Medical, Inc. Aug 27, 2021 |
| K211684 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) Aug 27, 2021 |
| K212038 — K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | K&J Consulting Corporation Aug 27, 2021 |
| K202746 — Surgical mask | Ningbo Jingeao Electronics, Inc. Aug 27, 2021 |
| K211524 — LOGIQ E10s, LOGIQ Fortis | GE Healthcare Aug 27, 2021 |
| K210610 — PrimeTaper EV Dental Implant | Dentsply Sirona, Inc. Aug 27, 2021 |