510(k) Clearances in 2021 — Page 43

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 43 of 61)
510(k) clearancesDetails
K202647 — Surgical MaskNingbo Green Textile Co., Ltd. Apr 26, 2021
K193070 — VIVACE Electrosurgical DeviceShenB Co., Ltd. Apr 26, 2021
K210347 — VSP System3D Systems Apr 26, 2021
K210918 — da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc. Apr 26, 2021
K202258 — ERISE Laser handpieceEl.En Electronic Engineering Spa Apr 26, 2021
K202464 — Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. Apr 26, 2021
K203264 — MicroDose InjectorMedone Surgical, Inc. Apr 26, 2021
K200260 — Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter SystemBoston Scientific Corporation Apr 26, 2021
K203512 — Powder Free Blue Nitrile Examination GloveVip Glove Sdn Bhd Apr 26, 2021
K210663 — Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd. Apr 26, 2021
K211010 — Illusion AlignersLaxmi Dental Exports Pvt, Ltd. Apr 26, 2021
K203854 — Pulse OximeterShenzhen Hexin Zondan Medical Equipment Co., Ltd. Apr 23, 2021
K211190 — 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)3M Company, Unitek Orthodontic Products Apr 23, 2021
K210007 — Face MaskJinhua Jingdi Medical Supplies Co., Ltd. Apr 23, 2021
K203605 — SteriTrakArbutus Medical, Inc. Apr 23, 2021
K210996 — ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. Apr 23, 2021
K210626 — SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation Apr 23, 2021
K202043 — Secret DuoIlooda Co,., Ltd. Apr 23, 2021
K210345 — 2MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation Apr 23, 2021
DEN200046 — Neurolutions Upper Extremity Rehabilitation SystemNeurolutions, Inc. Apr 23, 2021
K202462 — SIGMA Sterilization Pouch and RollSigma Medical Supplies Corporation Apr 23, 2021
K201853 — Naton Disposable Surgical Face MaskNaton Biotechnology (Beijing) Co., Ltd. Apr 23, 2021
K202607 — Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcsString King Lacrosse, LLC Apr 23, 2021
K210030 — Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd. Apr 23, 2021
K203502 — MEDO-ThyroidMedo DX Pte. , Ltd. Apr 23, 2021
K202387 — Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd. Apr 23, 2021
K203314 — Cartesion Prime (PCD-1000A/3) V10.8Canon Medical Systems Corporation Apr 23, 2021
K203835 — MIS SolutionNext Science, LLC Apr 23, 2021
K202257 — Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd. Apr 23, 2021
K210890 — GPS Cervical SpacersG Surgical, LLC Apr 23, 2021
K210312 — PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang , Ltd. Apr 23, 2021
K192190 — Solax Electric ScooterDongguan Prestige Sporting Goods Co., Ltd. Apr 23, 2021
K210885 — DayspringKoya Medical, Inc. Apr 23, 2021
K203735 — Brainsway Deep TMS SystemBrainsway , Ltd. Apr 23, 2021
K202915 — IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC Apr 23, 2021
K203570 — Mya Joy PLUS Breast PumpAmeda, Inc. Apr 22, 2021
K203365 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL CatheterShockwave Medical, Inc. Apr 22, 2021
K203646 — Disposable Medical Face MaskGuangzhou Mei YI Kang Medical Technology Co., Ltd. Apr 22, 2021
K203353 — DVT-PRODaesung Maref Co., Ltd. Apr 22, 2021
K210549 — ARx Spinal SystemLife Spine, Inc. Apr 22, 2021
K210482 — Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc. Apr 22, 2021
K210893 — Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Apr 22, 2021
K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin Apr 22, 2021
K200329 — IDCAM Dental ImplantsImplants Diffusion International Apr 22, 2021
K210065 — Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. Apr 22, 2021
K210525 — MY01 Continuous Compartmental Pressure MonitorMY01, Inc. Apr 22, 2021
K210961 — U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation Apr 21, 2021
K210851 — DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC Apr 21, 2021
K203533 — VASSALLO GTFilmecc Co., Ltd. Apr 21, 2021
K210580 — InnovaMatrix FSTriad Life Sciences, Inc. Apr 21, 2021
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