510(k) Clearances in 2022 — Page 11

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 11 of 65)
510(k) clearancesDetails
K203812 — Oxyfit Pulse OximeterShenzhen Viatom Technology Co., Ltd. Nov 8, 2022
K222132 — Hisense LCD monitor HMD2G21S, HMD3G21SQingdao Hisense Medical Equipment Co., Ltd. Nov 8, 2022
K222734 — Diversatek Healthcare PureFlo Irrigation System / Water Bottle TubingDiversatek Healthcare Nov 8, 2022
K222304 — Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. Nov 8, 2022
K222898 — SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC Nov 7, 2022
K220489 — Durex Patronus CloseFit, Durex Patronus RegularRb Health (Us), LLC Nov 7, 2022
K223127 — HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC Nov 7, 2022
K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC Nov 7, 2022
K212317 — Eclipse MINI Model 98900Spacelabs Healthcare, Ltd. Nov 7, 2022
K222936 — Humeris® 135 Shoulder SystemFx Shoulder USA, Inc. Nov 7, 2022
K222732 — WaveForm A Interbody SystemSeaSpine Orthopedics Corporation Nov 7, 2022
K222679 — Vericor Support CatheterVascupatent Medical (Shenzhen) Co., Ltd. Nov 7, 2022
K222800 — Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)Sanhe Laserconn Tech Co., Ltd. Nov 7, 2022
K220874 — Smooth Drive contra angle and straight handpiecesLares Research Nov 7, 2022
K222741 — DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)Hdi, Inc. Nov 7, 2022
K222873 — Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic Nov 7, 2022
K220346 — Lotus Prophy AngleAjk Engineering, Inc. Nov 7, 2022
K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackDiasorin Molecular, LLC Nov 5, 2022
K220833 — Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACLAcuitive Technologies, Inc. Nov 4, 2022
K221659 — Luminopia OneLuminopia, Inc. Nov 4, 2022
K213108 — Humerus & Ulna SystemAuxein Medical Private Limited Nov 4, 2022
K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics Nov 4, 2022
K222697 — Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd. Nov 4, 2022
K221007 — cobas HCVRoche Molecular Systems, Inc. Nov 4, 2022
K222049 — Yomi Robotic SystemNeocis, Inc. Nov 4, 2022
K221822 — BENCHMARK BMX81 Access SystemPenumbra, Inc. Nov 4, 2022
K220421 — BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp. Nov 4, 2022
K221675 — United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation Nov 4, 2022
K222453 — Self-adhesive ElectrodeGuangdong Comytens Medical Technology Co., Ltd. Nov 4, 2022
K221610 — Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. Nov 4, 2022
K222639 — VHA Radiotherapy BolusVha Dean Nov 4, 2022
K212764 — Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. Nov 4, 2022
K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Nov 4, 2022
K223164 — Aquilo Sports CCT1500 SystemAquilo Sports, LLC Nov 4, 2022
K223062 — World Total Knee SystemSignature Orthopaedics Pty, Ltd. Nov 4, 2022
K221162 — UniVy OsteoVy Cervical IBF SystemVy Spine, LLC Nov 4, 2022
K221086 — CryoRobot Select SystemTmrw Life Sciences, Inc. Nov 4, 2022
K221518 — NP Medical nCompass Extension Set with Stabilizing BaseNp Medical Nov 3, 2022
K221719 — ABTross ALIF Expandable Cage SystemAegis Spine, Inc. Nov 3, 2022
K223110 — truSculpt iDCutera, Inc. Nov 3, 2022
K220466 — ibiomedi Electronic Stethoscope ES-2020Sound Land Corp. Nov 3, 2022
K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc. Nov 3, 2022
K223355 — Tera Harz ClearGraphy, Inc. Nov 3, 2022
K222168 — Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and ToddlerOwen Mumford, Ltd. Nov 3, 2022
K221045 — Insulin Syringes without needleBerpu Medical Technology Co., Ltd. Nov 3, 2022
K222377 — Led Mask Platinum MdCellreturn Co., Ltd. Nov 3, 2022
K222107 — Black Diamond™ POCT Spinal SystemOsseus Fusion Systems Nov 3, 2022
K220371 — Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)Summit Glove, Inc. Nov 2, 2022
K222084 — OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet PreemieAsahi Polyslider Co., Ltd. Nov 2, 2022
K223320 — Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLingshi Hongruida Health Protection Technology Co., Ltd. Nov 2, 2022
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