510(k) Clearances in 2021 — Page 8

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 8 of 61)
510(k) clearancesDetails
K211432 — Myomics QPhantomics, Inc. Nov 23, 2021
K211956 — 039 Surgical Face MaskAok Tooling Limited Nov 23, 2021
K212101 — da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc. Nov 23, 2021
K211342 — Sofia 2 Campylobacter FIAQuidel Corporation Nov 23, 2021
K211347 — Uretero1 Ureteroscope SystemSTERIS Corporation Nov 23, 2021
K212150 — Exablate Prostate SystemInsightec, Inc. Nov 23, 2021
K211387 — Breathe Easy Mobile Respiratory Monitor (MRM)Sound Life Sciences, Inc. Nov 23, 2021
DEN210012 — vPatchVirility Medical Nov 23, 2021
K212529 — Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd. Nov 23, 2021
K211765 — Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse GownCardinal Health, LLC Nov 23, 2021
K202445 — Hystero-V HysteroscopeHysterovue, Inc. Nov 23, 2021
K213184 — MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin Nov 23, 2021
K210095 — Playboy Premium Silicone LubricantThai Nippon Rubber Industry Public Company Limited. Nov 23, 2021
K212169 — Air compression therapy system FO3002Foshan Hongfeng Co., Ltd. Nov 23, 2021
K212989 — Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd. Nov 22, 2021
K211741 — Pre-Formed Extra Support GuidewireLake Region Medical Nov 22, 2021
K211651 — Eclipse PROSpacelabs Healthcare, Ltd. Nov 22, 2021
K211854 — VITA Akzent LCVita Zahnfabrik GmbH H Rauter & CO Nov 22, 2021
K210265 — VS3 Iridium SytemVisionsense, Ltd. Nov 22, 2021
K211960 — Agile Esophageal OTW Stent SystemBoston Scientific Corporation Nov 22, 2021
K210990 — Non-sterile Powder Free Nitrile Examination GlovesRubberex Alliance Sdn Bhd Nov 22, 2021
K211168 — Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd. Nov 22, 2021
K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc. Nov 22, 2021
K213451 — Spartan MC 0165Spartan Micro Nov 22, 2021
K212697 — Leaf SmoothShenzhen Leaflife Technology Co., Ltd. Nov 19, 2021
K212661 — Disposable Nitrile Examination GloveInner Mongolia Cureguard Medical Technology Co., Ltd. Nov 19, 2021
K202288 — FinebeamSNJ Co., Ltd. Nov 19, 2021
K213421 — Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. Nov 19, 2021
K211080 — EkoSonic Endovascular DeviceBoston Scientific Nov 19, 2021
K213090 — Frontier Series Power WheelchairsMagic Mobility Nov 19, 2021
K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd. Nov 19, 2021
K210831 — OnQ NeuroCortechs Labs, Inc. Nov 19, 2021
K203074 — Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)Pt. Universal Gloves Nov 19, 2021
K212015 — BD Nano 2nd Gen Pen NeedleBecton, Dickinson And Company Nov 19, 2021
K212673 — MR 5300Philips Medical Systems Nederland B.V. Nov 19, 2021
K213213 — Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc. Nov 19, 2021
K211063 — HALYARD Flexaprene Green Powder-Free Exam GloveO&M Halyard, Inc. Nov 19, 2021
K211326 — EndoScreenerChengdu Wision Medical Device Co., Ltd. Nov 19, 2021
K212653 — Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. Nov 19, 2021
K210573 — Velofix SA Cervical CageU&I Corporation Nov 19, 2021
K212046 — Impertech Surgical Face MaskImpertech Industries , Ltd. Nov 18, 2021
K213041 — IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd. Nov 18, 2021
K211937 — SyneCare 1100 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd. Nov 18, 2021
K211871 — FAICO Dental Implant System and CAD/CAM AbutmentsFaico Medical, LLC Nov 18, 2021
K212487 — CoLink Vallux Plating SystemIn2Bones USA, LLC Nov 18, 2021
K212275 — Dermalux Flex MDAesthetic Technology, Ltd. Nov 18, 2021
K212104 — Water-soluble Personal LubricantFoshan Pingchuang Medical Technology Co., Ltd. Nov 18, 2021
K211662 — Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC Nov 18, 2021
K213070 — MD-320W Ultrasound BiomicroscopeMEDA Co., Ltd. Nov 18, 2021
K212600 — Disposable Medical Nitrile Examination Gloves (Non-sterile)Suqian Linglian Medical Technology Co., Ltd. Nov 18, 2021
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