510(k) Clearances in 2022 — Page 4

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 4 of 65)
510(k) clearancesDetails
K220591 — ProximaDynasthetics, LLC Dec 15, 2022
K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)Spectranetics, Inc. Dec 15, 2022
K214086 — Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-PuttyGenoss Co., Ltd. Dec 15, 2022
K221555 — Dozee VSTurtle Shell Technologies Private Limited Dec 15, 2022
K221267 — VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Dec 15, 2022
K221102 — LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd. Dec 15, 2022
K221453 — S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. Dec 15, 2022
K222892 — Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. Dec 15, 2022
K220520 — PM Excellence SEQUR 100 Surgical Face MaskPm Excellence, LLC Dec 15, 2022
K220883 — Small Field ApplicatorHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Dec 15, 2022
K213722 — ICE Ceramics, ICE Stains, FrescoZirkonzahn Srl Dec 14, 2022
K221800 — Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science And Technology Co., Ltd. Dec 14, 2022
K220079 — Magicore Narrow SystemInnobiosurg Co., Ltd. Dec 14, 2022
K221910 — QRS Dental Implants SystemQrs Medical , Ltd. Dec 14, 2022
K221891 — UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. Dec 14, 2022
K222527 — Nitrile Patient Examination GlovePingan Medical Products Co., Ltd. Dec 14, 2022
K222623 — Digital CrownSprintray, Inc. Dec 14, 2022
K222533 — Target Tetra Detachable CoilsStryker Neurovascular Dec 14, 2022
K220971 — QuikClot Control+ Hemostatic DressingZ-Medica, LLC Dec 14, 2022
K221245 — PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. Dec 14, 2022
K220046 — Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11Shenzhen Superbio Technology Co., Ltd. Dec 13, 2022
K212071 — Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxCefaly Technology Dec 13, 2022
K214004 — CCBIO ASCPO NeedleCc Biotechnology Corporation Dec 13, 2022
K222651 — Surgical Face MaskXiantao Sanda Industrial Co., Ltd. Dec 13, 2022
K221318 — HVT 2.0Vapotherm, Inc. Dec 13, 2022
K213105 — Epilaser AbsoluteEpilady 2000, LLC Dec 13, 2022
K221342 — REDEMPTION Beaming SystemVilex, LLC Dec 13, 2022
K223433 — Quantra QPlus SystemHemosonics, LLC Dec 13, 2022
K222770 — Conductive GelTop-Rank Health Care Co., Ltd. Dec 13, 2022
K220921 — Metal Bone ScrewDouble Medical Technology, Inc. Dec 12, 2022
K202674 — Medidenta High Speed HandpiecesPac-Dent, Inc. Dec 12, 2022
K220926 — Spectra WearableUzinmedicare Co., Ltd. Dec 12, 2022
K223510 — Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc. Dec 12, 2022
K223190 — Hive™ Standalone Cervical SystemNanoHive Medical, LLC Dec 12, 2022
K221642 — SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited Dec 12, 2022
K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics Dec 12, 2022
K212957 — BioButton SystemBiolntellisense, Inc. Dec 12, 2022
K222733 — Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)Inner Mongolia Boming Medical Supplies Co., Ltd. Dec 11, 2022
K220822 — 3D-SHAPER3D-Shaper Medical S.L Dec 9, 2022
K223195 — AIROS 6P Sequential Compression DeviceAiros Medical, Inc. Dec 9, 2022
K221280 — VessealLydus Medical , Ltd. Dec 9, 2022
K223193 — AIROS 8P Sequential Compression DeviceAiros Medical, Inc. Dec 9, 2022
K223275 — CELLO II Balloon Guide CatheterFuji Systems Corporation Dec 9, 2022
K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments Dec 9, 2022
K223403 — LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc. Dec 9, 2022
K220951 — PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. Dec 9, 2022
K222916 — US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd. Dec 9, 2022
K222242 — FloPatch FP120Flosonics Medical Dec 9, 2022
K221598 — Wearable breast pumpMayborn (Uk) Limited Dec 9, 2022
K220774 — RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd. Dec 9, 2022
← Previous Page 4 of 65 Next →