510(k) Clearances in 2021 — Page 32

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 32 of 61)
510(k) clearancesDetails
K201844 — Surgical Face Mask, Surgical MaskLear Corporation Jul 14, 2021
K202989 — Myopia MasterOculus Optikgeräte GmbH Jul 14, 2021
K202304 — NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)Nyu Langone Medical Center Jul 14, 2021
K203562 — Finetest Lite Blood Glucose Monitoring SystemOsang Healthcare Co. , Ltd. Jul 13, 2021
K211237 — UltraTemp Rez IIUltradent Products, Inc. Jul 13, 2021
K192739 — Electric Wheelchair [Models: JRWD6010/JRWD6012]Jerry Medical Instrument (Shanghai) Co., Ltd. Jul 13, 2021
K200210 — ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, Inc. Jul 13, 2021
K211938 — Physica LMC Knee SystemLimacorporate Jul 13, 2021
K210244 — Disposable Medical Face MaskSuzhou Bolisi Medical Technology Co., Ltd. Jul 12, 2021
DEN200039 — InSpace Subacromial Tissue Spacer SystemOrtho-Space , Ltd. Jul 12, 2021
K210717 — Bone Screws dia. 5,0 mmLima Corporate S.P.A. Jul 12, 2021
K210723 — Nitrile Patient Examination GloveJiangxi Zhonghong Pulin Medical Products Co., Ltd. Jul 12, 2021
K211491 — RadiForce RX370Eizo Corporation Jul 12, 2021
K210492 — InMode RF Pro SystemInmode MD , Ltd. Jul 12, 2021
K210386 — Magneto Nasal MaskRespironics, Inc. Jul 12, 2021
K211113 — Zavation Spinal SystemZavation Medical Products, LLC Jul 12, 2021
K211506 — PowerLook Density Assessment V4.0Icad, Inc. Jul 12, 2021
K203556 — Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient CablesMedtronic, Inc. Jul 12, 2021
K211495 — EOS PMPSorin Group Italia S.R.L. Jul 12, 2021
K210776 — Nitrile Examination Gloves5R Med Instruments (Chengdu) Co., Ltd. Jul 12, 2021
K210578 — Medical Nitrile Examination Gloves (Power free, Blue)Jiangxi Hongda Medical Equipment Group , Ltd. Jul 10, 2021
K201262 — Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd. Jul 9, 2021
K210821 — Medical PVC Examination GlovesJiangxi Hongda Medical Equipment Group , Ltd. Jul 9, 2021
K202517 — Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc. Jul 9, 2021
K210012 — Tamarin Blue PTCA RX Dilatation CatheterNatec Medical , Ltd. Jul 9, 2021
K211574 — Extreme X8Magic Mobility Jul 9, 2021
K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH Jul 9, 2021
K211493 — Monarch PlatformAuris Health, Inc. Jul 9, 2021
K210602 — AortaSTAT Occlusion DeviceRenalpro Medical, Inc. Jul 9, 2021
K211542 — PRIMO SA.T.S. Applicazione Tecnologie Speciali S.R.L. Jul 9, 2021
K200575 — TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEMTruemed Group, LLC Jul 9, 2021
K211107 — BTL-899 FPBTL Industries, Inc. Jul 9, 2021
K201675 — VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)bioMerieux, Inc. Jul 9, 2021
K210713 — HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jul 9, 2021
K211088 — Grosz Play FeelRb Health (Us), LLC Jul 9, 2021
K200915 — Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy DrugsGx Corporation Sdn Bhd Jul 9, 2021
K210380 — Medical surgical maskShantou T&K Medical Equipment Factory Co.,Ltd Jul 8, 2021
K210945 — Ultra SEPReliance Orthodontic Products, Inc. Jul 8, 2021
K192971 — Nebulizer KitExcellentcare Medical (Huizhou) , Ltd. Jul 8, 2021
K211480 — NubeXTechheim Co., Ltd. Jul 8, 2021
K203659 — iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd. Jul 8, 2021
K202579 — TruAbutment DS, TruBaseTruabutment, Inc. Jul 8, 2021
K211094 — Nerve and Muscle StimulatorShenzhen Xft Medical Limited Jul 8, 2021
K211465 — HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences Jul 8, 2021
K211052 — Straumann RidgeFit ImplantsInstitut Straumann AG Jul 8, 2021
K210104 — SurroundScope System270Surgical , Ltd. Jul 8, 2021
K211442 — StealthStation Spinous Process ClampsMedtronic Navigation Jul 8, 2021
K202922 — END 200 Endoscopic TubesetPalliare , Ltd. Jul 8, 2021
K211788 — HALONicolab B.V. Jul 8, 2021
K201835 — PRE-SURELazarus 3D, Inc. Jul 8, 2021
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