510(k) Clearances in 2021 — Page 49

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 49 of 61)
510(k) clearancesDetails
K210209 — Viz ICHViz. Ai, Inc. Mar 23, 2021
K210555 — 7D Surgical System - Drill Guide7D Surgical, Inc. Mar 23, 2021
K203620 — Aneroid SphygmomanometerWuxi Exanovo Medical Instrument Co., Ltd. Mar 23, 2021
K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics Mar 22, 2021
K202009 — Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026Shenzhen Juzhong Technology Co., Ltd. Mar 22, 2021
K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitGold Standard Diagnostics Mar 22, 2021
K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics Mar 22, 2021
K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics Mar 22, 2021
K202492 — EZ-IO Intraosseous Vascular Access SystemTeleflex Medical Mar 22, 2021
K203737 — Spark Clear Aligner SystemOrmco Corporation Mar 22, 2021
K203612 — Capture-CMVImmucor, Inc. Mar 22, 2021
K203052 — Movement and Compressions System (the MAC System)Recovery Force, LLC Mar 21, 2021
K202628 — Disposable Medical Face MaskQinghai Zhong Dao Win-Win Medical Protective Equipment Co., Mar 19, 2021
K210120 — BonOs HV, BonOs MV, BonOs LVOsartis GmbH Mar 19, 2021
K210472 — SPINEART Navigation Instrument SystemSpineart Mar 19, 2021
K202081 — Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, BlueShen Wei USA, Inc. Mar 19, 2021
K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH Mar 19, 2021
K203116 — SensorXDurr Dental SE Mar 19, 2021
K202985 — LightWalker Laser System FamilyFotona D.O.O. Mar 19, 2021
K203235 — VBrainVysioneer, Inc. Mar 19, 2021
K203593 — Patient Examination GlovesGuangdong Kingfa Sci. & Tech.Co., Ltd. Mar 19, 2021
K192731 — ZIDA Wearable Neuromodulation SystemExodus Innovations Mar 19, 2021
K210479 — IMPACT and X-RangerMinxray, Inc. Mar 19, 2021
K202379 — Invacare AVIVA Storm RX Power ChairInvacare Corporation Mar 19, 2021
K201095 — Sovereign America Surgical Face MaskHomtex, Inc. Mar 19, 2021
K210041 — HySil Plus Impression MaterialsOsstem Implant Co., Ltd. Mar 18, 2021
K202773 — s-Clean SQ-SL Implant System MiniDentis Co., Ltd. Mar 18, 2021
K210584 — SDC3 HD Information Management System with Wireless Device Control CapabilityStryker Mar 18, 2021
K202482 — Y207 Electric WheelchairJiangsu Intco Medical Products Co., Ltd. Mar 18, 2021
K201624 — Spin Care Disposable Protective MaskSpintech, LLC Mar 18, 2021
K203444 — BEE HA CageNGMedical GmbH Mar 18, 2021
K200925 — Clarus Peel-Away Introducer SheathClarus Medical, LLC Mar 18, 2021
K203679 — Automatic RegistrationBrainlab AG Mar 18, 2021
K210286 — Cure 2.0 Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC Mar 18, 2021
K203342 — CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. Mar 18, 2021
K201681 — Straumann Immediate Temporary AbutmentsInstitut Straumann AG Mar 18, 2021
K210449 — Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic Mar 18, 2021
K202937 — Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. Mar 18, 2021
K210285 — Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC Mar 18, 2021
K210551 — Persona Revision Knee SystemZimmer, Inc. Mar 18, 2021
K203186 — DYNATAPE SutureMedos International SARL Mar 18, 2021
K203361 — ProLift Wedge Expandable Spacer SystemLife Spine, Inc. Mar 17, 2021
DEN200031 — BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC Mar 17, 2021
K202082 — Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric AcidShen Wei USA, Inc. Mar 17, 2021
K203684 — Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd. Mar 17, 2021
K203428 — Ziehm Vision RFDZiehm Imaging GmbH Mar 17, 2021
K203083 — Magic 360 Power WheelchairMagic Mobility Mar 17, 2021
K210450 — BBX-PET ScannerPrescient Imaging, LLC Mar 17, 2021
K203252 — Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. Mar 16, 2021
K201723 — F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd. Mar 16, 2021
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