510(k) Clearances in 2022 — Page 16

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 16 of 65)
510(k) clearancesDetails
K212702 — IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd. Oct 13, 2022
K222473 — EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl Oct 13, 2022
K220853 — PicoWay Laser SystemCandela Corporation Oct 13, 2022
K222113 — Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc. Oct 13, 2022
K220857 — X-CUBE 50, X-CUBE 60Alpinion Medical Systems Co., Ltd. Oct 13, 2022
K222087 — SCIg60 Infusion SystemEmed Technologies Corporation Oct 13, 2022
K220730 — allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc. Oct 13, 2022
K203638 — AT-Patch ECG Analysis SystemAtsens Co., Ltd. Oct 12, 2022
K220923 — Elecsys HSV-1 IgG (08948844160)Roche Diagnostics Oct 12, 2022
K221576 — Ameda Pearl Electric Breast PumpAmeda, Inc. Oct 12, 2022
K220924 — Elecsys HSV-2 IgG (08948887160)Roche Diagnostics Oct 12, 2022
K221263 — Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. Oct 12, 2022
K221913 — Arm Blood Pressure MonitorAlicn Medical Shenzhen, Inc. Oct 12, 2022
K222064 — The Alma Soprano TitaniumAlma Lasers, Inc. Oct 12, 2022
K221510 — TrusFIL-Flow Flowable Composite RestorativeRizhao Huge Biomaterials Company, Ltd. Oct 12, 2022
K220911 — Elecsys CMV IgGRoche Diagnostics Oct 12, 2022
K221712 — Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O. Oct 12, 2022
K211872 — PiezoImplant SystemRex Implants, Inc. Oct 12, 2022
K213120 — OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt Oct 12, 2022
K220227 — Auto Folding Scooter, S21FHeartway Medical Products Co., Ltd. Oct 12, 2022
K222068 — Durex Penck III RegularRb Health (Us), LLC Oct 12, 2022
K220102 — MOST-T AutoclaveShinva Medical Instrument Co., Ltd. Oct 12, 2022
K222157 — ECHO PhotocoagulatorNorlase Oct 11, 2022
K220169 — SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)Bionet Co., Ltd. Oct 11, 2022
K222079 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice ControlStryker Endoscopy Oct 11, 2022
K222744 — Sol-M Luer Lock SyringeSol-Millennium Medical, Inc. Oct 11, 2022
K222432 — IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd. Oct 11, 2022
K222335 — Surgical MaskLuoyang Sunmed Devices Co., Ltd. Oct 11, 2022
K222435 — Renamel® Microhybrid ;Renamel® Flowable MicrohybridCosmedent, Inc. Oct 11, 2022
K221830 — Apyx One ConsoleApyx Medical Corporation Oct 11, 2022
K214116 — AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd. Oct 11, 2022
K221951 — Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. Oct 11, 2022
K223008 — Disposable Vinyl Examination GlovesJiangxi Handspro Products Solutions Co., Ltd. Oct 8, 2022
K221310 — Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd. Oct 7, 2022
K221498 — Miha Bodytec IIMiha Bodytec GmbH Oct 7, 2022
K221492 — SteriTite Container System with MediTray PartsCase Medical, Inc. Oct 7, 2022
K220709 — BriefCaseAidoc Medical , Ltd. Oct 7, 2022
K221170 — Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107Shenzhen AOJ Medical Technology Co., Ltd. Oct 7, 2022
K221764 — InBody Blood pressure monitor, Model BPBIO480KVInbody Co., Ltd. Oct 7, 2022
K220256 — MIM-AblationMim Software, Inc. Oct 7, 2022
K221818 — Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG Oct 7, 2022
K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose ImmunizationShinva Ande Healthcare Apparatus Co., Ltd. Oct 7, 2022
K220156 — Electrically Powered Wheelchair, Joy RiderTung Keng Enterprise Co., Ltd. Oct 7, 2022
K221154 — Infant Heel WarmerTM; Heel Snuggler®International Biomedical Oct 7, 2022
K222424 — Protect-It Custom Fit Dental GuardDoc Brands, Inc. Oct 7, 2022
K213610 — Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper ForcepsKatalyst Surgical, LLC Oct 7, 2022
K220092 — YADU Surgical GownsHenan Yadu Industrial Co., Ltd. Oct 7, 2022
K222028 — IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody SystemAlphatec Spine Oct 7, 2022
K222369 — PURE LaserEndymed Medical, Ltd. Oct 7, 2022
K221575 — Pre-Formed BlueLake Region Medical Oct 7, 2022
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