510(k) Clearances in 2021 — Page 35

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 35 of 61)
510(k) clearancesDetails
K202196 — BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc. Jun 24, 2021
K210948 — Omnilux CLEARGlobalmed Technologies Jun 24, 2021
K211623 — THD Procto Software SystemThd Spa Jun 24, 2021
K203590 — Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. Jun 24, 2021
K203725 — S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. Jun 23, 2021
K210258 — NovoFineNovo Nordisk, Inc. Jun 23, 2021
K211408 — CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. Jun 23, 2021
K211045 — Synthetic Vinyl Examination GlovesJiangsu Huayuan Medical Technology Co., Ltd. Jun 23, 2021
K211595 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. Jun 23, 2021
K211695 — Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices Jun 23, 2021
K211596 — CD Horizon Spinal SystemMedtronic Jun 23, 2021
K203456 — Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG Jun 23, 2021
K201806 — Reprocessed PentaRay Nav eco High-Density Mapping CatheterSterilmed Inc. (Johnson And Johnson) Jun 23, 2021
K211606 — Mariner Deformity SystemSeaSpine Orthopedics Corporation Jun 23, 2021
K201935 — Air Pressure Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd. Jun 22, 2021
K202991 — Fotona XPulse Pro Laser PlatformFotona D.O.O. Jun 22, 2021
K210840 — Disposable Surgical MaskSafeway Industry Healthcare. Jun 22, 2021
K210881 — M Series Phototherapy EquipmentDaavlin Distributing Co. Jun 22, 2021
K211215 — SenoBright HDGE Healthcare Jun 22, 2021
K210161 — AnyOne Onestage Implant SystemMegagen Implant Co., Ltd. Jun 22, 2021
K211272 — ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl Jun 22, 2021
K210882 — MolecuLight I:XMolecuLight, Inc. Jun 22, 2021
K203720 — MICROMATEIsys Medizintechnik GmbH Jun 22, 2021
K203019 — LF900Daesung Maref Co., Ltd. Jun 22, 2021
K202085 — Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, GreenShen Wei USA, Inc. Jun 21, 2021
K210855 — Straumann BLX Implant SystemInstitut Straumann AG Jun 21, 2021
K210866 — Steri-Dot Process IndicatorPropper Manufacturing Co., Inc. Jun 21, 2021
K202902 — 2430MCA with Xmaru WRayence Co., Ltd. Jun 21, 2021
K202855 — Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L. Jun 21, 2021
K193301 — coDiagnostiXDental Wings GmbH Jun 21, 2021
K210375 — Powder Free Blue Nitrile Examination GloveDuramitt Sdn Bhd Jun 21, 2021
K201737 — Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd. Jun 21, 2021
K211250 — VisionPort SystemNew View Surgical, Inc. Jun 21, 2021
K210457 — 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key7D Surgical, Inc. Jun 21, 2021
K210899 — LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG Jun 21, 2021
K210430 — Intravascular Extension SetBaxter Healthcare Corporation Jun 18, 2021
K202964 — iBed Wireless with iBed MobileStryker Corporation Jun 18, 2021
K202893 — Transcutaneous Electrical Nerve StimulatorWuxi Jiajian Medical Instrument Co., Ltd. Jun 18, 2021
K210220 — Kontact Dental Implant SystemBiotech Dental, Sas Jun 18, 2021
K210495 — Port Access SystemSurgical Innovations Limited Jun 18, 2021
K201314 — Restor3d Utility WedgeRestor3D, Inc. Jun 17, 2021
K202806 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd. Jun 17, 2021
K210364 — Migraine Tens Digital Pain RelieverShenzhen Dongdixin Technology Co., Ltd. Jun 17, 2021
K210700 — NaviNetics D1 Stereotactic SystemNavinetics, Inc. Jun 17, 2021
K211535 — Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. Jun 17, 2021
K210886 — MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona Jun 17, 2021
K210883 — aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8Ambu A/S Jun 17, 2021
K202440 — Infrared ThermometerShenzhen Sonida Digital Technology Co., Ltd. Jun 17, 2021
K203514 — Precise PositionPhilips Healthcare (Suzhou) Co., Ltd. Jun 17, 2021
K201744 — Su2ura Approximation DeviceAnchora Medical, Ltd. Jun 17, 2021
← Previous Page 35 of 61 Next →