510(k) Clearances in 2021 — Page 15
Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.
| 510(k) clearances | Details |
|---|---|
| K202808 — Brainance MD | Advantis Medical Imaging Single Member P.C. Oct 14, 2021 |
| K210999 — SwiftMR | Airs Medical, Inc. Oct 14, 2021 |
| K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit | Intera Oncology, Inc. Oct 14, 2021 |
| K211753 — Sterile Syringe With Safety Needle | Jiangxi Hongda Medical Equipment Group , Ltd. Oct 14, 2021 |
| K210231 — Vittra APS Unique | Dentscare Ltda Oct 14, 2021 |
| K211807 — Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. Oct 14, 2021 |
| K213002 — SCORPION Portal Vein Access Set | Argon Medical Devices Oct 14, 2021 |
| K212205 — Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. Oct 14, 2021 |
| K211914 — Nitrile Patient Examination Gloves | Yingxiang Glove Products Co., Ltd. Oct 14, 2021 |
| K211461 — Family of Venus RF Systems - Venus Freedom | Venus Concept USA, Inc. Oct 14, 2021 |
| K211214 — Sterile Hypodermic Needles for Single Use | Azur Medical Company, Inc. Oct 14, 2021 |
| K202688 — AFS Medical Sterile Single-Use Access Port System | Afs Medical Co. , Ltd. Oct 14, 2021 |
| K211147 — ALGO 7i | Path Medical GmbH Oct 14, 2021 |
| K212544 — MiniLoad Syringe | Ocuject, LLC Oct 13, 2021 |
| K210116 — Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Oct 13, 2021 |
| K212908 — EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device | Neuravi, Ltd. Oct 13, 2021 |
| K212014 — Medical Nitrile Examination Gloves | Jiangxi Ronglai Medical Technology Co., Ltd. Oct 13, 2021 |
| K212825 — CoreLink Navigation Instruments | Corelink, LLC Oct 13, 2021 |
| K211374 — Proclean - Nitrile Powder Free Examination Gloves | Dr.Boo Company Limited Oct 13, 2021 |
| K211801 — SPRINT PNS System | Spr Therapeutics, Inc. Oct 13, 2021 |
| K211905 — UltraCal XS | Ultradent Products, Inc. Oct 13, 2021 |
| K212560 — Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) Oct 12, 2021 |
| K210845 — Disposable Surgical Mask (Model: YYKZ-01) | Jiaxing Amazing Travel-Ware Co., Ltd. Oct 12, 2021 |
| K212552 — Correx Software | Vilex, LLC Oct 12, 2021 |
| K212562 — Idys-C ZP 3DTi | Clariance, SA Oct 12, 2021 |
| K212307 — BC Reflex Uni Knee System | Bodycad Laboratories, Inc. Oct 12, 2021 |
| K211927 — Nitrile examination gloves | Fitone Latex Products Co., Ltd. Guangdong Oct 12, 2021 |
| K212116 — VBrain-OAR | Vysioneer, Inc. Oct 12, 2021 |
| K201514 — Child Face Mask | Shandong Shengquan New Material Co., Ltd. Oct 10, 2021 |
| K212174 — STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. Oct 9, 2021 |
| K203750 — Straumann CARES P-Series CAD/CAM System | Institut Straumann AG Oct 9, 2021 |
| K210813 — Medical Surgical Mask | Sichuan Pharmaceutical., Inc. Oct 8, 2021 |
| K210211 — PuraStat-OM | 3-D Matrix, Inc. Oct 8, 2021 |
| K203497 — Infrared Thermometer (Model K9) | Kangzhan Communication Electronics Co., Ltd. Oct 8, 2021 |
| K212520 — ProLift Micro Expandable Spacer System | Life Spine, Inc. Oct 8, 2021 |
| K210128 — INTEGRA Wound Matrix (Macro-Channels) | Integra LifeSciences Corporation Oct 8, 2021 |
| K212078 — Medical Examination Gloves | Guangdong Gymda Medical Technology Co.,Ltd Oct 8, 2021 |
| K201989 — B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. Oct 8, 2021 |
| K212156 — ABCcolla Bone Matrix | Acro Biomedical Co., Ltd. Oct 8, 2021 |
| K212479 — Cohitech Reusable Tampon Applicator | Cotton High Tech S.L. Oct 8, 2021 |
| K203688 — Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. Oct 8, 2021 |
| K201210 — The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH Oct 8, 2021 |
| K210622 — Single-Use Medical Face Mask | Jiangxi Hongda Medical Equipment Group Co., Ltd. Oct 8, 2021 |
| K212876 — Carescape SpO2 - Masimo | Masimo Corporation Oct 8, 2021 |
| K211706 — Esophageal TTS Stent | Taewoong Medical Co., Ltd. Oct 8, 2021 |
| K211680 — Streamline Surgical System | New World Medical, Inc. Oct 8, 2021 |
| K211406 — OASIS MRI System | Hitachi Healthcare Americas Oct 7, 2021 |
| K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Remington Medical, Inc. Oct 7, 2021 |
| K210376 — Superior Hair Remover | Guangzhou Haoxingwan Technology Co., Ltd. Oct 7, 2021 |
| K211211 — Sterile syringes for single use with/without needle | Azur Medical Company, Inc. Oct 7, 2021 |