510(k) Clearances in 2022 — Page 49

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 49 of 65)
510(k) clearancesDetails
K212929 — Nitrile Examination GlovesWatchtower Ppe Supplies, Inc. Apr 9, 2022
K220401 — Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test ClaimRiverstone Resources Sdn Bhd Apr 9, 2022
K213509 — Latex Examination Gloves, Powder FreeShandong Intco Medical Products Co, Ltd. Apr 8, 2022
K202389 — Oxygen ConcentratorFoshan Mic Medical Technology Co., Ltd. Apr 8, 2022
K213958 — Bioabsorbable AnchorEmbody, Inc. Apr 8, 2022
K213015 — DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. Apr 8, 2022
K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC Apr 8, 2022
K212882 — SCOUT BX Delivery SystemMerit Medical Systems, Inc. Apr 8, 2022
K220724 — CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International Apr 8, 2022
K220490 — ImaCor Zura Handheld ZHH-010Imacor, Inc. Apr 8, 2022
K220144 — Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TNoras Mri Products GmbH Apr 8, 2022
K212274 — INT ContourCarina Medical, LLC Apr 8, 2022
K220192 — Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Apr 8, 2022
K220809 — Drive Rail SystemOrthoPediatrics Corp. Apr 8, 2022
K212309 — Non-sterile, Powder-Free Latex Examination GloveSri Trang Gloves (Thailand) Public Company Limited Apr 8, 2022
K213063 — TLX SRAs and TLX Gold AbutmentsInstitut Straumann AG Apr 8, 2022
K212372 — Fitbit Irregular Rhythm NotificationsFitbit, Inc. Apr 8, 2022
K212017 — Thermeo SystemPro3Dure Medical GmbH Apr 8, 2022
K220699 — Prestige Coil SystemBait USA, LLC Apr 8, 2022
K210109 — visor2 systemEemagine Medical Imaging Solutions GmbH Apr 8, 2022
K212203 — Dong Hai Xiang Surgical MaskTaizhou Donghaixiang Protective Equipment Co., Ltd. Apr 7, 2022
K212278 — ElectrocardiographEdan Instruments, Inc. Apr 7, 2022
K211203 — Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC Apr 7, 2022
K210860 — Comfort Guard Mask, level 1, Comfort Guard Mask, level 3Gri-Alleset, Inc. Apr 7, 2022
K212069 — Corin MetaFix™ Hip StemCorin U.S.A. Limited Apr 7, 2022
K220287 — Invisalign SystemAlign Technology, Inc. Apr 7, 2022
K202106 — Plasmage SystemBrera Medical, Inc. Apr 6, 2022
K202534 — MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. Apr 6, 2022
K220625 — ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemRemed Co., Ltd. Apr 6, 2022
K213506 — NB 1 SA Implant SystemArum Dentistry Co., Ltd. Apr 6, 2022
K210593 — Onera Sleep Test System (Onera STS)Onera B.V. Apr 6, 2022
K214085 — Disposable Medical MaskHubei Wanli Protective Products Co., Ltd. Apr 6, 2022
K210714 — Extended ReservoirMedtronic Minimed, Inc. Apr 6, 2022
K214114 — Prodigy Thrombectomy SystemTruvic Medical, Inc. Apr 6, 2022
K203783 — ClariPulmoClaripi, Inc. Apr 6, 2022
K213578 — Balloon Dilatation CatheterHangzhou AGS MedTech Co., Ltd. Apr 6, 2022
K213809 — 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader3M Company Apr 6, 2022
K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation Apr 6, 2022
K214081 — MRCAT Head & NeckPhilips OY Apr 5, 2022
K220335 — Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Apr 5, 2022
K213450 — Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. Apr 5, 2022
K220364 — Accu-Chek Safe-T-Pro Uno Lancing DeviceRoche Diabetes Care, Inc. Apr 5, 2022
K220043 — HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Apr 5, 2022
K213746 — Digital thermometer, Model DT101, DT102Guangzhou Berrcom Medical Device Co., Ltd. Apr 5, 2022
K213560 — Verifine Safety Syringe with Fixed NeedlePromisemed Hangzhou Meditech Co., Ltd. Apr 5, 2022
K213808 — Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test MidstreamCo-Innovation Biotech Co., Ltd. Apr 5, 2022
K212463 — Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi PackGeistlich Pharma AG Apr 5, 2022
K200946 — Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)Taidoc Technology Corporation Apr 5, 2022
K213011 — Infrared Thermometer (model: E201)Bioland Technology, Ltd. Apr 5, 2022
K212601 — DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company Apr 5, 2022
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