| K212956 — FDR Cross (DR-XD 3000) | Fujifilm Corporation Nov 8, 2021 |
| K212895 — Paragon 28 External Ring Fixation System | Paragon 28, Inc. Nov 8, 2021 |
| K202371 — Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. Nov 8, 2021 |
| K211356 — GIQuant | Motilent, Ltd. Nov 8, 2021 |
| K212504 — Isolation Gown AAMI Level 3 | Kenpax International Limited Nov 7, 2021 |
| K212506 — Medical Examination Gloves (Tested for Use with Chemotherapy) | Guangdong Gymda Medical Technology Co.,Ltd Nov 7, 2021 |
| K212523 — VFSS Pro Mobile Digital Imaging System | Imagexray, LLC Nov 5, 2021 |
| K211817 — Anterion | Heidelberg Engineering GmbH Nov 5, 2021 |
| K212900 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 5, 2021 |
| K212460 — Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) | Guangzhou Zhengkang Medical Equipment Co.,Ltd Nov 5, 2021 |
| K211055 — Microcurrent device (Model: HBR2-1) | Shenzhen DJ Medical Equipment Co., Ltd. Nov 5, 2021 |
| K202676 — Disposable Medical Face Mask | Zhejiang Senhong Medical&Instrument Co., Ltd. Nov 5, 2021 |
| K212551 — Nitrile Examination Gloves | Anhui Fine Glove Medical Technology Co., Ltd. Nov 5, 2021 |
| K212853 — Cervical Stand-Alone System | Eminent Spine, LLC Nov 5, 2021 |
| K210859 — NextAR Spine Platform | Medacta International S.A. Nov 5, 2021 |
| K212896 — Visible Patient Suite | Visible Patient, Sas Nov 5, 2021 |
| K212707 — CoolSculpting Elite System | Zeltiq Aesthetics, Inc. Nov 5, 2021 |
| K212485 — Disposable Nitrile Examination gloves | Fujian Yuanxin Safety Protection Technology Co., Ltd. Nov 5, 2021 |
| K212044 — TrueLok Evo | Orthofix Srl Nov 5, 2021 |
| K211577 — SoftFix Balloon Trocar | Unimax Medical Systems, Inc. Nov 5, 2021 |
| K211726 — Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Nov 5, 2021 |
| K210253 — Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. Nov 5, 2021 |
| K212502 — Resonic Rapid Acoustic Pulse Device | Soliton, Inc. Nov 5, 2021 |
| K211971 — Drug Relief v1 | Dyansys, Inc. Nov 5, 2021 |
| K202110 — MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. Nov 5, 2021 |
| K211288 — Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Microlife Intellectual Property GmbH Nov 4, 2021 |
| K212937 — Dakota ALIF Plate System | Precision Spine, Inc. Nov 4, 2021 |
| K212912 — OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | B-One Ortho, Corp. Nov 4, 2021 |
| K212467 — Disposable Nitrile Examination Glove | Inner Mongolia Boming Medical Supplies Co., Ltd. Nov 4, 2021 |
| K212511 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) | Stryker Nov 4, 2021 |
| K210628 — X-FLO Fluid Management System | Thermedx, LLC Nov 4, 2021 |
| K212496 — Ortho Aligner System | Ortho Lab Services, LLC Nov 4, 2021 |
| K212897 — IPL Hair Removal Device, model: AI01 | Shenzhen Century Dongyuan Technology CO , Ltd. Nov 4, 2021 |
| K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner | Biomet Manufacturing Corp Nov 4, 2021 |
| K212019 — Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | Jiangsu Micsafe Medical Technology Co., Ltd. Nov 4, 2021 |
| K212510 — 7 Series Phototherapy Device | Daavlin Distributing Co. Nov 4, 2021 |
| K212471 — Medical Face Mask | Haian Medigauze Co., Ltd. Nov 4, 2021 |
| K211103 — Powder Free Vinyl Examination Gloves | Shanghai Shengda Medical Applications Co., Ltd. Nov 4, 2021 |
| K210384 — CARESCAPE R860 | Datex-Ohmeda, Inc. Nov 4, 2021 |
| K201320 — Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | Qura S.R.L Nov 3, 2021 |
| K212537 — REAL INTELLIGENCE CORI (CORI) | Blue Belt Technologies, Inc. Nov 3, 2021 |
| K210432 — LELTEK Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. Nov 3, 2021 |
| K202732 — SOL-CARE IV Bag Safety Connector | Sol-Millennium Medical Group Nov 3, 2021 |
| K210543 — IM007 | Implicity, Inc. Nov 3, 2021 |
| K212404 — S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. Nov 3, 2021 |
| K210969 — Nulife | Mrk Healthcare Pvt, Ltd. Nov 3, 2021 |
| K212515 — MOVIX DReamy | Stephanix Nov 3, 2021 |
| K212446 — NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated Nov 3, 2021 |
| DEN200040 — OMNIgene GUT Dx | DNA Genotek, Inc. Nov 3, 2021 |
| K211947 — GlideScope BFlex 2.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc Nov 3, 2021 |