510(k) Clearances in 2022 — Page 6

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 6 of 65)
510(k) clearancesDetails
K223055 — Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd. Dec 5, 2022
K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production Dec 5, 2022
K222692 — BriefCaseAidoc Medical , Ltd. Dec 5, 2022
K221612 — ClearRead CTRiverain Technologies, Inc. Dec 5, 2022
K222614 — Zavation Spinal SystemZavation Medical Products, LLC Dec 5, 2022
K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)Stryker Sustainability Solutions Dec 4, 2022
K223004 — Disposable Nitrile Examination GlovesJiangxi Handspro Products Solutions Co., Ltd. Dec 4, 2022
K222815 — Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and FentanylZibo Lanhua Medical Packaging Material Co., Ltd. Dec 4, 2022
K222720 — Blue Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited Dec 3, 2022
K212866 — truSculpt flexJohari Digital Healthcare Limited Dec 3, 2022
K222713 — White Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited Dec 3, 2022
K222715 — Black Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited Dec 3, 2022
K221141 — PageWriter TC35 CardiographMedizin Systeme Boblingen GmbH Dec 2, 2022
K220611 — SUREcore Plus Biopsy InstrumentUro-1, Inc. Dec 2, 2022
K223218 — Parietene Macroporous MeshSofradim Production Dec 2, 2022
K221410 — Maestro PlatformMoon Surgical Dec 2, 2022
K223353 — DropSafeTM SicuraTMPikdare Spa Dec 2, 2022
K223369 — truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184STERIS Corporation Dec 2, 2022
K213465 — CardioGrapheArineta , Ltd. Dec 2, 2022
K221113 — Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. Dec 2, 2022
K223211 — INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC Dec 2, 2022
K221401 — Self-Cath and Self-Cath PlusColoplast Dec 2, 2022
K220688 — SilentZPro 2.0Shinrin-Yoku Traders, LLC Dec 2, 2022
K223072 — PENTAX Medical Video Esophagoscope EE17-J10Pentax Of America, Inc. Dec 2, 2022
K221590 — NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd. Dec 2, 2022
K220778 — Chemical Indicator for SteamTrue Indicating, LLC Dec 2, 2022
K220390 — CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. Dec 2, 2022
K221747 — Nitrile Patient Examination Gloves Tested For Use With Chemotherapy DrugsFitone Latex Products Co., Ltd. Guangdong Dec 1, 2022
K222368 — MIST ICImagine Milling Technologies, LLC Dec 1, 2022
K222340 — Chartis Precision CatheterPulmonx Corporation Dec 1, 2022
K222118 — 2-Way 100% Silicone Cleartract CatheterSilq Technologies, Corp. Dec 1, 2022
K222125 — Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GShenzhen AOJ Medical Technology Co., Ltd. Dec 1, 2022
K222516 — Mercury® II Spinal SystemSpinal Elements, Inc. Dec 1, 2022
K220786 — STAR Apollo Mapping SystemRhythm Al, Ltd. Dec 1, 2022
K221791 — ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. Dec 1, 2022
K222710 — IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd. Dec 1, 2022
K222297 — CentriMag Pre-connected PackAbbott Dec 1, 2022
K213768 — Bolt Navigation SystemCircinus Medical Technology, LLC Dec 1, 2022
K223226 — Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. Dec 1, 2022
K222044 — Elos Accurate Customized AbutmentElos Medtech Pinol A/S Nov 30, 2022
K221771 — EEA Circular Stapler with Tri-Staple TechnologyCovidien Nov 30, 2022
K222299 — Steripath Micro Blood Collection SystemMagnolia Medical Technologies Nov 30, 2022
K222472 — Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. Nov 30, 2022
K212717 — Paneffort AAMI Level 3 Isolation GownPaneffort, LLC Nov 30, 2022
K222305 — MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. Nov 30, 2022
K221082 — Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and FentanylRhino Health, Inc. Nov 30, 2022
K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft , Ltd. Nov 30, 2022
K223328 — PurgoAeroclean Technologies, Inc. Nov 30, 2022
K213943 — SmartSurgN Visualization SystemSmartsurgn Incorporated Nov 29, 2022
K222641 — Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien Nov 29, 2022
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