510(k) Clearances in 2021 — Page 53

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 53 of 61)
510(k) clearancesDetails
K203439 — Disposable Vinyl Examination GlovesShandong Zhushi Pharmaceutical Group Co., Ltd. Feb 26, 2021
K203819 — T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail SystemStryker GmbH Feb 26, 2021
K202167 — Brite Tip Radianz Guiding SheathCordis Corporation Feb 26, 2021
DEN190022 — Hominis Surgical SystemMomentis Surgical , Ltd. Feb 26, 2021
K201967 — SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd. Feb 26, 2021
K200567 — ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc. Feb 26, 2021
K203182 — SubtleMRSubtle Medical, Inc. Feb 26, 2021
K202045 — imani i1Imani Co. Feb 26, 2021
K202549 — Solax Electric Scooter (Model: S202261B)Dongguan Prestige Sporting Goods Co., Ltd. Feb 26, 2021
K173738 — ArchworxUtah Medical Products And Services Feb 26, 2021
K210033 — Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation Feb 26, 2021
K203020 — Spectral CTPhilips Medical Systems Nederland B.V. Feb 26, 2021
K201316 — Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. Feb 26, 2021
K210268 — LTJ Screws and WasherAzurmeds, Inc. Feb 26, 2021
K202240 — Disposable Surgical Mask/Fluid Resistant Procedure MaskLhm Medical Technology (Hong Kong) Limited Feb 25, 2021
K202990 — NinesMeasureNines, Inc. Feb 25, 2021
K201142 — TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety setSimplivia Healthcare , Ltd. Feb 25, 2021
K202420 — Infrared Forehead ThermometerConmo Electronic Company Limited Feb 25, 2021
K203665 — STOP U Model UXV DevicePollogen, Ltd. Feb 25, 2021
K203524 — Surgical MasksBain Medical Equipment (Guangzhou) Co., Ltd. Feb 25, 2021
K203477 — ClassicOrthoapnea S.L. Feb 25, 2021
K203332 — Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816CHetaida Technology Co., Ltd. Feb 25, 2021
K203578 — OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging Ai, Inc. Feb 25, 2021
K203247 — iFuse-TORQ™ Implant SystemSI-BONE, Inc. Feb 25, 2021
K201436 — Vortek Single Loop Ureteral StentColoplast Corp. Feb 25, 2021
K202988 — Tixel SystemNovoxel , Ltd. Feb 25, 2021
K201969 — SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd. Feb 25, 2021
K201945 — KARL STORZ UDEL Sterilization TraysKarl Storz Endoscopy America, Inc. Feb 25, 2021
K201971 — SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd. Feb 25, 2021
K202514 — EchoS FamilyEcholight S.P.A Feb 25, 2021
K210230 — Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular Feb 25, 2021
K201906 — Trinity ELE Plus and Trinity ELE Plus ProCarol Cole Company Dba Nuface Feb 24, 2021
K202184 — Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC Feb 24, 2021
K203479 — ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed Feb 24, 2021
K201703 — PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH Feb 24, 2021
K210195 — Triever CathetersInari Medical Feb 24, 2021
K210202 — BioWaveGO RXBiowave Corporation Feb 24, 2021
K200734 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V. Feb 24, 2021
K202003 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance ClaimGmp Medicare Sdn. Bhd. Feb 24, 2021
K210239 — CITRESPLINE and CITRELOCK ACL ImplantsAcuitive Technologies, Inc. Feb 24, 2021
K203255 — 4K UHD LaparoscopeScivita Medical Technology Co., Ltd. Feb 24, 2021
K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppCochlear Americas Feb 23, 2021
K200439 — Velano ExT Extension SetVelano Vascular Feb 23, 2021
K210269 — PowerDot PD-01MT2 Muscle StimulatorSmartmissimo Technologies Pte, Ltd. Feb 23, 2021
K201915 — GenesisZr 4Y+ (ST1100) ZirconiaUnited Dental Resources Corporation Feb 23, 2021
K203784 — PreXion3D Explorer PROPrexion Corporation Feb 23, 2021
K202950 — StitchKit COMBOOrigami Surgical Feb 23, 2021
DEN200028 — Lumenis Stellar M22Lumenis, Ltd. Feb 23, 2021
K203494 — Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. Feb 23, 2021
K210190 — ClotTriever Thrombectomy SystemIrani Medical, Inc. Feb 23, 2021
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