510(k) Clearances in 2021 — Page 47

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 47 of 61)
510(k) clearancesDetails
K202129 — Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PresbyoLargan Medical Co., Ltd. Apr 1, 2021
K202032 — Idys LLIF 3DTiClariance, Sas Apr 1, 2021
K203795 — Star RF Electrode, VIVA RF ElectrodeStarmed Co., Ltd. Apr 1, 2021
K210340 — Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Apr 1, 2021
K210743 — ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Apr 1, 2021
K210668 — TSolution One Total Knee ApplicationTHINK Surgical, Inc. Apr 1, 2021
K202365 — Pentax Medical Video Duodenoscope ED32-i10Pentax Of America, Inc. Apr 1, 2021
K203195 — Simpleware ScanIP MedicalSynopsys (Northern Europe) , Ltd. Apr 1, 2021
K202206 — AMG PMP PediatricEurosets S.R.L Apr 1, 2021
K202154 — B-CaptaLivanova Deutschland, GmbH Apr 1, 2021
K202228 — Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. Apr 1, 2021
K203782 — Nanox Cart X-ray SystemNano-X Imaging , Ltd. Apr 1, 2021
K203258 — syngo.CT Lung CADSiemens Healthcare GmbH Mar 31, 2021
K210631 — Avitus(r) Bone HarvesterAvitus Orthopaedics, Inc. Mar 31, 2021
K203378 — PulsehalerRespinova, Ltd. Mar 31, 2021
K202424 — Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd. Mar 31, 2021
K210654 — EnCor Breast Biopsy Probe with Rinse TubeSenorx, Inc. Mar 31, 2021
K203101 — Secure Wear USA Surgical Face MaskSecured Ortho Manufacturing Of America, LLC Mar 31, 2021
K210071 — SIS System (Version 5.1.0)Surgical Information Sciences, Inc. Mar 31, 2021
K200502 — Myriad ParticlesAroa Biosurgery , Ltd. Mar 31, 2021
K210110 — GuidionImds Operations B.V. Mar 31, 2021
K201879 — Digital Thermometer Model T103, T104Bioland Technology, Ltd. Mar 31, 2021
K210616 — Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC Mar 31, 2021
K203443 — MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc. Mar 31, 2021
K210057 — Blue Nitrile Exam Glove, Powder FreeReal Star Medical Technology Co., Ltd. Mar 31, 2021
K210308 — EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P. Mar 30, 2021
K202708 — Surgical Face MasksIntco Medical(Hk) Co., Ltd. Mar 30, 2021
K210226 — PicoSure WorkstationCynosure, LLC Mar 30, 2021
K203836 — BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd Mar 30, 2021
K210603 — 3M Bair Hugger Temperature Management System (Model 675)3M Company Mar 30, 2021
K201896 — ivi N3003 Surgical face Mask, ivi N6006 Surgical maskIob Medical, Inc. Mar 30, 2021
K203641 — E-Denture ProEnvisiontec GmbH Mar 30, 2021
K201001 — Modulith SLX-F2Karl Storz Endoscopy America Mar 30, 2021
K210058 — Blue Nitrile Exam Glove, Powder FreeGreat Harvest Trading Co., Ltd. Mar 30, 2021
K202191 — Surgical MaskWuhan Zonsen Medical Products Co., Ltd. Mar 29, 2021
K203505 — DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH Mar 29, 2021
K210173 — StarGuideGE Healthcare Mar 29, 2021
K203827 — REMIEpitel, Inc. Mar 29, 2021
K203826 — LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc. Mar 29, 2021
K200601 — LumiCare Caries Diagnostic RinseGreenMark Biomedical, Inc. Mar 29, 2021
K201590 — EMMA CapnographMasimo Corporation Mar 29, 2021
K203417 — DVT-4000SDaesung Maref Co., Ltd. Mar 28, 2021
K201466 — Tranberg CLS Laser ApplicatorClinical Laserthermia Systems, AB Mar 26, 2021
K202905 — Disposable Face MaskJiangsu Excellence Medical Supplies Co., Ltd. Mar 26, 2021
K202751 — TandemHeart Pump and Escort ControllerCardiacassist, Inc. Mar 26, 2021
K210207 — Humeral Eccentric Reverse MetaphysisMedacta International S.A. Mar 26, 2021
DEN200019 — Oxehealth Vital SignsOxehealth Limited Mar 26, 2021
K201634 — RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd. Mar 26, 2021
K201921 — Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd. Mar 26, 2021
K203788 — DermaV Laser SystemLutronic Corporation Mar 26, 2021
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