510(k) Clearances in 2021 — Page 51

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 51 of 61)
510(k) clearancesDetails
K202375 — ZOLL Propaq MZOLL Medical Corporation Mar 9, 2021
K201508 — Infrared ThermometerDongguan Prestige Sporting Goods Co., Ltd. Mar 9, 2021
K202205 — Surgical Face MaskJiangsu Micsafe Medical Technology Co., Ltd. Mar 9, 2021
K203600 — VersaWrapAlafair Biosciences, Inc. Mar 9, 2021
K202710 — Disposable Medical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd. Mar 9, 2021
K202591 — Body Infrared Thermometer HT-820DDongguan Xintai Instrument Co., Ltd. Mar 9, 2021
K203256 — Imbio RV/LV SoftwareImbio, LLC Mar 9, 2021
K201678 — iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. Mar 8, 2021
K202439 — Disposable Medical Face MaskHunan Eexi Technology & Service Co., Ltd. Mar 8, 2021
K201728 — Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria E Comercio Ltda. Mar 8, 2021
K203351 — Perfit ZR HT Dental Zirconia blankVatech Acucera, Inc. Mar 8, 2021
K200660 — Compressible Limb and Circulation Therapy SystemWonjin Mulsan Co., Ltd. Mar 8, 2021
K202753 — iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd. Mar 8, 2021
K202125 — Century Perfusion SystemCentury Hlm, LLC Mar 7, 2021
K201974 — Single-use medical face maskGuangdong Horigen Mother & Baby Products Co., Ltd. Mar 7, 2021
K210390 — Apex 3D Total Ankle Replacement SystemParagon 28, Inc. Mar 6, 2021
K201581 — CPR BANDCredo Mar 6, 2021
K202078 — Biodegradable Thermoplastic Elastomer Examination (TPE) GloveShen Wei USA, Inc. Mar 5, 2021
K191441 — Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)Maxstar Industrial Co., Ltd. Mar 5, 2021
K210328 — SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC Mar 5, 2021
K202913 — NeuroCap (Model DEC22)Memory MD, Inc. Mar 5, 2021
K201775 — NuVision ICE CatheterNuvera Medical, Inc. Mar 5, 2021
K201420 — Republic Spine Dark Star Spinal SystemRepublic Spine, LLC Mar 5, 2021
K203054 — FlexSysGme German Medical Engineering GmbH Mar 5, 2021
K202693 — NeoWave Pain Relief and Recovery System, Model# T16-2020Eva Medtec, Inc. Mar 5, 2021
K202076 — Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray ColorsShen Wei USA, Inc. Mar 5, 2021
K202838 — Andorate Universal Endoscope Tip GuardGa Health Company Limited Mar 5, 2021
K202300 — Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd. Mar 5, 2021
DEN200006 — ClearUP Sinus ReliefTivic Health Systems, Inc. Mar 5, 2021
K210309 — Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. Mar 5, 2021
K201285 — InMode Evolve System with the Tone ApplicatorInMode , Ltd. Mar 5, 2021
K203425 — Surgical MaskBdc Dental Corporation , Ltd. Mar 5, 2021
K202658 — Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound And Primary Care Diagnostics Mar 5, 2021
K203146 — Akesis Galaxy RTiAkesis, Inc. Mar 5, 2021
K203346 — OEC 3DGe Oec Medical Systems, Inc. Mar 5, 2021
K203261 — Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC Mar 5, 2021
K210307 — Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. Mar 4, 2021
K203193 — BD Intraosseous Infusion SystemBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary Of Bd] Mar 4, 2021
K202137 — Disposable medical maskU-Play Products Corporation Mar 4, 2021
K210006 — MI DeTACHBiorep Technologies, Inc. Mar 4, 2021
K203387 — AlignRT PlusVision Rt, Ltd. Mar 4, 2021
K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor ActivationHill-Rom, Inc. Mar 4, 2021
K210019 — Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+Unimed Medical Supplies, Inc. Mar 4, 2021
K210225 — Surgical Face MaskFeng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. Mar 4, 2021
K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186Carefusion 2200, Inc. Mar 4, 2021
K203323 — Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Mar 4, 2021
K203521 — FineCross M3Ashitaka Factory Of Terumo Corporation Mar 3, 2021
K210043 — LOQTEQ Distal Lateral Femur Plate 4.5 SystemAap Implantate AG Mar 3, 2021
K202518 — Promaxo MRI SystemPromaxo, Inc. Mar 3, 2021
K210282 — WIRION Embolic Protection SystemCardiovascular Systems, Inc. Mar 3, 2021
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