| K213946 — Compass BDS Biliary Stent | Cook Ireland, Ltd. May 9, 2022 |
| K211840 — Sight OLO | S.D. Sight Diagnostics , Ltd. May 9, 2022 |
| K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | Neuronetics, Inc. May 6, 2022 |
| K213900 — WAVi SCAN EEG System and Accessories | Wavi Co. May 6, 2022 |
| K220664 — NewTom 7G | Cefla S.C. May 6, 2022 |
| K212555 — Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC | Covidien, LLC May 6, 2022 |
| K214108 — Medline Orbis Chemo Surgical Gown | Medline Industries, LP May 6, 2022 |
| K211966 — Segment 3DPrint | Medviso AB May 6, 2022 |
| K211685 — Elecsys Testosterone II | Roche Diagnostics May 6, 2022 |
| K214072 — Masimo O3 Regional Oximeter System | Masimo Corporation May 6, 2022 |
| K212564 — Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. May 6, 2022 |
| K213788 — TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) | Dongguan Bohuikang Technology Co.,Ltd May 6, 2022 |
| K213935 — PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems May 6, 2022 |
| K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L May 6, 2022 |
| K212657 — Quantum Heater-Cooler | Spectrum Medical , Ltd. May 6, 2022 |
| K213975 — KEOPS Balance Analyzer 3D | S.M.A.I.O May 6, 2022 |
| K203711 — IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. May 6, 2022 |
| K221046 — Invu by Nuvo | Nuvo- Group , Ltd. May 6, 2022 |
| K220269 — HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. May 6, 2022 |
| K211021 — Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. May 6, 2022 |
| K213884 — Disposable EEG cable | Shenzhen Changke Connect Electronics Co., Ltd. May 6, 2022 |
| K212582 — SpyGlass Discover Balloon Dilation Catheter | Boston Scientific Corporation May 6, 2022 |
| K212092 — Portable Folding Electric Wheelchair (Model: DC01) | Anhui Jbh Medical Apparatus Co., Ltd. May 6, 2022 |
| K220689 — Vatech Clismile | Rayence Co., Ltd. May 6, 2022 |
| K220653 — Astroglide Glycerin & Paraben Free | Biofilm, Inc. May 6, 2022 |
| K221016 — Steriking Packaging for Medical Devices | Wipak OY May 5, 2022 |
| K220691 — LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension | Seigla Medical, Inc. May 5, 2022 |
| K221044 — AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. May 5, 2022 |
| K210411 — PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC May 5, 2022 |
| K212756 — Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL May 5, 2022 |
| K221057 — Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular May 5, 2022 |
| K212434 — Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut Für Physik Und Medizin GmbH May 5, 2022 |
| K210565 — Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | Alicn Medical Shenzhen, Inc. May 5, 2022 |
| K221013 — GIA Auto Suture Stapler with DST Series Technology | Covidien May 5, 2022 |
| K212346 — Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 | Shenzhen Pango Medical Electronics Co., Ltd. May 5, 2022 |
| K220559 — 17HQ901G-B | Lg Electronics.Inc May 5, 2022 |
| K220716 — Spartan SC 069 | Spartan Micro, Inc. May 5, 2022 |
| K220041 — HandPICO | Vydence Medical Industria E Comercio Ltda May 5, 2022 |
| K220685 — HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | Qingdao Hightop Biotech Co., Ltd. May 5, 2022 |
| K211529 — NAVIRFA Scope | Navifus Corporation May 5, 2022 |
| K220030 — Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC May 4, 2022 |
| K213526 — Aurora-RT | Magnettx Oncology Solutions , Ltd. May 4, 2022 |
| K212588 — Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | C.R. Bard, Inc. May 4, 2022 |
| K220700 — Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine | Yian Medical Technology (Haining) Co., Ltd. May 4, 2022 |
| K212257 — Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 | Alicn Medical Shenzhen, Inc. May 4, 2022 |
| K220704 — Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC May 4, 2022 |
| K201302 — LiveOne | Livemetric (Medical) S.A. May 4, 2022 |
| K213550 — HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. May 4, 2022 |
| K211036 — Plus Medical Chemotherapy Gown | Foshan Nanhai Plus Medical Co, Ltd. May 4, 2022 |
| K220705 — MyKnee R Pin Positioners | Medacta International S.A. May 4, 2022 |