510(k) Clearances in 2022 — Page 32

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 32 of 65)
510(k) clearancesDetails
K213961 — TruAbutment DS, TruBaseTruabutment, Inc. Jul 14, 2022
K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control SetDiaSorin, Inc. Jul 14, 2022
K221429 — KDF Zirconia DiscDenken-Highdental Co., Ltd. Jul 14, 2022
K220204 — Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needleAnhui Tiankang Medical Technology Co., Ltd. Jul 14, 2022
K221097 — SmileSeriesOrdont Orthodontic Laboratories, Inc. Jul 14, 2022
K220258 — 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)Avia Vascular Jul 14, 2022
K203013 — AGNESAgnes Medical Co., Ltd. Jul 14, 2022
K220348 — Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-VRemex Medical Corporation Jul 14, 2022
K221666 — Normatec GoNormaTec Industries, LP Jul 14, 2022
K221434 — 17HQ701G-BLg Electronics.Inc Jul 13, 2022
K221407 — truSculpt iDCutera, Inc. Jul 13, 2022
K210354 — SNUCONE Bone Level Implant SystemSnucone Co., Ltd. Jul 13, 2022
K221727 — syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. Jul 13, 2022
K221108 — Nitrile Medical Examination GlovesAnhui Fulewei Electronic Technology Co.,Ltd Jul 12, 2022
K213899 — VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS CaspofunginbioMerieux, Inc. Jul 12, 2022
K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation Jul 12, 2022
DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX SystemApollo Endosurgery, Inc. Jul 12, 2022
K213143 — HemoclipHangzhou AGS MedTech Co., Ltd. Jul 12, 2022
K220814 — NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc. Jul 12, 2022
K213574 — Nitrile Vinyl Blend Powder Free Examination Gloves (Black)Grand Work Plastic Products Co., Ltd. Jul 12, 2022
K221083 — Smartlux MiniMedmix Co., Ltd. Jul 12, 2022
K221454 — Disposable Medical Nitrile Examination Gloves - Non SterileGuangzhou Kangling Biotechnology Co., Ltd. Jul 12, 2022
K213799 — N Series Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 12, 2022
K220415 — Protrieve SheathInari Medical, Inc. Jul 12, 2022
K203279 — Veuron-Brain-mN1Heuron Co., Ltd. Jul 12, 2022
K220095 — ANNE SleepSibel, Inc. Jul 11, 2022
K220538 — DolorClast RadialE.M.S Electro Medical Systems S.A Jul 11, 2022
K221364 — Mitek TIGHT-N AnchorMedos International SARL Jul 11, 2022
K221846 — Artix Ballon Guiding SheathInari Medical Jul 11, 2022
K220480 — RevogeneMeridian Bioscience, Inc. Jul 11, 2022
K213405 — MINE ALNU (Model: Mine 2.1)Hdt Co., Ltd. Jul 10, 2022
K220573 — NoodlePourang Bral, Dds, LLC Jul 9, 2022
K220643 — DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety LancetsHtl-Strefa S.A Jul 8, 2022
K220284 — Powder Free Nitrile Examination Gloves (Blue)Kgm Gloves Sdn. Bhd. Jul 8, 2022
K220825 — Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC Jul 8, 2022
K213782 — Single-Use Video Bronchoscopes, Digital ControllerMicro-Tech (Nanjing) Co., Lts Jul 8, 2022
K221399 — ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc. Jul 8, 2022
K221051 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankChangsha Honchon Technology Co., Ltd. Jul 8, 2022
K212783 — ProstatIDScanmed, LLC Jul 8, 2022
K210793 — VIDAS NEPHROCHECKBiomérieux SA Jul 8, 2022
K213009 — Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. Jul 8, 2022
K220424 — Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. Jul 8, 2022
K212775 — Adin Short ImplantsAdin Dental Implants Systems , Ltd. Jul 8, 2022
K210228 — KLS Martin IPS PreprostheticKLS-Martin L.P. Jul 8, 2022
K221346 — Stryker VariAx 2 MIS CalcaneusStryker GmbH Jul 8, 2022
K201440 — ROTEM sigma Thromboelastometry SystemTem Innovations GmbH Jul 8, 2022
K221293 — E-Brik Visualization AssistantJdi Surgical, Inc. Jul 7, 2022
K213387 — AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. Jul 7, 2022
K213056 — LED Facial MaskShenzhen Osto Technology Company Limited Jul 7, 2022
K220771 — Stratasys TrueDentStratasys, Ltd. Jul 7, 2022
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