510(k) Clearances in 2021 — Page 45

3,023 510(k) clearances total

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 in 2021 (page 45 of 61)
510(k) clearancesDetails
K210338 — Edge Insulated Blade ElectrodeCovidien, LLC Apr 15, 2021
K203364 — MDPC-8127Barco N.V. Apr 15, 2021
K210493 — CX30N (CX30PQX)Wide Corporation Apr 14, 2021
K203390 — Artimes pro Balloon Dilatation CatheterBrosmed Medical Co., Ltd. Apr 14, 2021
K203449 — F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd. Apr 14, 2021
K201127 — DEFEND Ear-loop Face MasksYoung Dental Manufacturing Co. 1, LLC Apr 14, 2021
K210754 — Cannulated Fasteners and NutsOsteoCentric Technologies Apr 14, 2021
K202617 — Metapex PlusMeta Biomed Co., Ltd. Apr 14, 2021
K201138 — AMSure® Single Use Saline Topical SolutionAmsino Medical, Inc. Apr 14, 2021
K202992 — BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical , Ltd. Apr 14, 2021
K210752 — HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. Apr 14, 2021
K202906 — EndoPilot2Schlumbohm GmbH & Co. KG Apr 13, 2021
K202884 — SR-1 Skin Treatment SystemAVAVA, Inc. Apr 13, 2021
K210658 — Volition Plating SystemOrtho Solutions UK , Ltd. Apr 13, 2021
K210764 — FlytePelvital USA, Inc. Apr 13, 2021
K202136 — IDS CortisolImmunodiagnostic Systems , Ltd. Apr 13, 2021
K210197 — NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation Apr 13, 2021
K210088 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM LaparoscopesStryker Apr 13, 2021
K203500 — RetCam EnvisionNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Apr 13, 2021
K203751 — OMNIVision systemCorin USA Apr 12, 2021
K210087 — Athena Surgical RMUS SystemAthena Surgical, LLC Apr 12, 2021
K210456 — Ligament StapleMedacta International S.A. Apr 12, 2021
K203210 — Invacare Platinum 5NXG Oxygen ConcentratorInvacare Corporation Apr 12, 2021
K210629 — SecurAcathInterrad Medical, Inc. Apr 12, 2021
K200919 — Idys ALIF 3DTiClariance Apr 12, 2021
K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation Apr 12, 2021
K202679 — Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3Mcgovern Medical School Apr 12, 2021
K210436 — Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 AsphereAlcon Laboratories, Inc. Apr 12, 2021
K203012 — Surgical MaskCustomfab, Inc. Apr 11, 2021
K191479 — Velocity Alpha Highspeed Surgical Drill SystemAdeor Medical AG Apr 11, 2021
K202761 — Medical Surgical Mask (Non-sterile)Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. Apr 11, 2021
K210018 — Disposable Medical MaskDiasia Biomedical Technology Co., Ltd. Apr 11, 2021
K201903 — Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd. Apr 9, 2021
K202325 — EasyPoint Blood Collection PlusRetractable Technologies, Inc. Apr 9, 2021
K202084 — DeepLook PRECISEDeeplook, Inc. Apr 9, 2021
K202748 — Enteral Feeding CatheterMedcaptain Life Science Co., Ltd. Apr 9, 2021
K203681 — RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose ReviewBrainlab AG Apr 9, 2021
K203000 — KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) Apr 9, 2021
K201563 — PuRE PMMA DiscQuest Dental USA Corp. Apr 9, 2021
K203742 — IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. Apr 9, 2021
K203571 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. Apr 9, 2021
K210418 — HYPER FocusShanghai United Imaging Healthcare Co., Ltd. Apr 9, 2021
K210068 — HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Apr 9, 2021
K202513 — Disposable Medical Face Mask-Model FM-04Shenzhen Jinko Industrial Co., Ltd. Apr 9, 2021
DEN200055 — GI GeniusCosmo Artificial Intelligence - Ai, Ltd. Apr 9, 2021
K193630 — hekaDrillZethon, Ltd. Apr 9, 2021
K210162 — Endoscope Model EI-740D/SFujifilm Corporation Apr 9, 2021
K210710 — PENTAX Medical Video Duedenoscope ED34-i10T2Pentax Of America, Inc. Apr 9, 2021
K202134 — Well Lead All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co., Ltd. Apr 8, 2021
K210491 — CW120NWide Corporation Apr 8, 2021
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