510(k) Clearances in 2022

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 1 of 65)
510(k) clearancesDetails
K222002 — Persyst 15 EEG Review and Analysis SoftwarePersyst Development Corporation Dec 30, 2022
K222767 — PeekMed web (v1)Peek Health, S.A. Dec 30, 2022
K222010 — Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies , Ltd. Dec 30, 2022
K223616 — Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation Dec 30, 2022
K221796 — Cyware 4H and Cysart 4HAbys Medical Dec 30, 2022
K223605 — ControlSeal Electrode (ELSB)Coapt Dec 30, 2022
K213260 — CMFlexTMDimension Inx Corp. Dec 30, 2022
K222872 — DNA ApplianceVivos Therapeutics, Inc. Dec 30, 2022
K214041 — Aesculap AICON ContainerAesculap, Inc. Dec 30, 2022
K222195 — aprevo® Digital WorkflowCarlsmed, Inc. Dec 30, 2022
K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc. Dec 30, 2022
K210313 — EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterShanghai Microport EP Medtech Co., Ltd. Dec 30, 2022
K213430 — Fingertip Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd. Dec 30, 2022
K223687 — X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd. Dec 30, 2022
K221477 — AG100sHospitech Respiration , Ltd. Dec 29, 2022
K221981 — SafeR Syringe and SafeR StingRoncadelle Operations Srl Dec 29, 2022
K223603 — Reflow System Mini and ReFlow Mini FlusherAnuncia Medical, Inc. Dec 29, 2022
K221859 — AtalanteWandercraft SAS Dec 29, 2022
K211557 — EndoPATxItamar Medical , Ltd. Dec 29, 2022
K223647 — CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc. Dec 29, 2022
K221690 — OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)Olympus Medical Systems Corp. Dec 29, 2022
K222984 — BioClean Implant Restorative SystemBioclean Dental, LLC Dec 29, 2022
K211619 — Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd Dec 29, 2022
K221333 — Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC Dec 29, 2022
K223592 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and PushersBoston Scientific Corporation Dec 29, 2022
K222528 — Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe ElectrodeWell-Life Healthcare Limited Dec 29, 2022
K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd. Dec 29, 2022
K223324 — Total Bilirubin2Abbott Ireland Diagnostics Division Dec 29, 2022
K223286 — BD AutoShield Duo™ Pen NeedleBecton, Dickinson And Company Dec 28, 2022
K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XPOlympus Medical Systems Corp. Dec 28, 2022
K223654 — Medussa-PL CageMedyssey USA, Inc. Dec 28, 2022
K222760 — StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. Dec 28, 2022
K221344 — nView s1 with nav optionNview Medical Dec 28, 2022
K221990 — Access Total ßhCG (5th IS)Beckman Coulter, Inc. Dec 27, 2022
K223094 — EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software LicenseABBOTT MEDICAL Dec 27, 2022
K222978 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. Dec 27, 2022
K221669 — IOB Warming BlanketsIob Medical, Inc. Dec 27, 2022
K220974 — R:GENLutronic Vision, Inc. Dec 27, 2022
K222726 — Smartpump 3.0 Double Electric Breast PumpLansinoh Laboratories Dec 23, 2022
K210017 — ACTOnco, ACTOnco IVDAct Genomics Dec 23, 2022
K221708 — CIMILRE Free-T2 PlusCimilre Co., Ltd. Dec 23, 2022
K221193 — OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO , Ltd. Dec 23, 2022
K214002 — CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc. Dec 23, 2022
K223565 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.L&K BIOMED Co., Ltd. Dec 23, 2022
K222748 — ShiNeo Silicone ImplantShineo Technology Co., Ltd. Dec 23, 2022
K221765 — ONLINE DAT Benzodiazepines IIRoche Diagnostics Dec 23, 2022
K214036 — AVIEWCoreline Soft Co., Ltd. Dec 23, 2022
K223442 — MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. Dec 23, 2022
K223289 — Access Vitamin B12Beckman Coulter, Inc. Dec 23, 2022
K212239 — XENOVIEW 3.0T Chest CoilPolarean, Inc. Dec 23, 2022
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