510(k) Clearances in 2022 — Page 29

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 29 of 65)
510(k) clearancesDetails
K221907 — RhinAer® Stylus (FG1393)Aerin Medical, Inc. Jul 29, 2022
K221251 — Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd. Jul 29, 2022
K221259 — Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. Jul 29, 2022
K220989 — Next Generation NetKonnectNihon Kohden Digital Health Solutions, Inc. Jul 29, 2022
K211370 — Tablo Hemodialysis SystemOutset Medical, Inc. Jul 29, 2022
K221901 — EleGARDAdvancedcpr Solutions, LLC Jul 29, 2022
K221914 — Catapult Guide SheathContract Medical International, GmbH Jul 29, 2022
K220331 — 091 Balloon Guide CatheterInneuroco, Inc. Jul 29, 2022
K213104 — Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited Jul 29, 2022
K220577 — Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. Jul 29, 2022
K213911 — Microstream CO2 NanoPodCovidien, LLC Jul 29, 2022
K212982 — Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited Jul 29, 2022
K220961 — Deep Learning Image ReconstructionGe Healthcare Japan Corporation Jul 29, 2022
K213760 — ABMD SoftwareHeartLung Corporation Jul 29, 2022
K211585 — Bodyport Cardiac ScaleBodyport, Inc. Jul 29, 2022
K213914 — Injection NeedleJiangsu Vedkang Medical Science And Technology Co., Ltd. Jul 29, 2022
K220063 — Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd. Jul 28, 2022
K221905 — INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC Jul 28, 2022
K221332 — OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies Jul 28, 2022
K221235 — neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. Jul 28, 2022
K221923 — Swoop Portable MR Imaging SystemHyperfine, Inc. Jul 28, 2022
K214122 — BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson And Company Jul 28, 2022
K221230 — TRONXoran Technologies, LLC Jul 28, 2022
K222014 — EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation Jul 28, 2022
K221898 — Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences Jul 28, 2022
K213998 — cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. Jul 28, 2022
K212113 — MagXtract Collection TubeMagbio Genomics, Inc. Jul 28, 2022
K221922 — TriniasShimadzu Corporation Medical Systems Division Jul 28, 2022
K222017 — BiotresBiotricity Jul 28, 2022
K221945 — Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cmConmed Corporation Jul 28, 2022
K211385 — KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA Jul 27, 2022
K213507 — AquaAFresenius Medical Care Rental Therapies Group, LLC Jul 27, 2022
K220958 — Real Intelligence CoriBlue Belt Technologies, Inc. Jul 27, 2022
K221430 — reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. Jul 27, 2022
K221269 — Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl CitrateBetter Care Plastic Technology Co., Ltd. Jul 27, 2022
K210902 — EliA Ro52, EliA Ro60Phadia AB Jul 27, 2022
K213252 — Dornier ThulioDornier Medtech America, Inc. Jul 27, 2022
K221464 — CorPath GRX SystemCorindus, Inc. Jul 27, 2022
K211496 — TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc) Jul 27, 2022
K214007 — HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc. Jul 27, 2022
K221687 — Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd. Jul 27, 2022
K220886 — Upper Arm Type Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd. Jul 27, 2022
K221271 — Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)Shandong Maida Medical Technology Co., Ltd. Jul 27, 2022
K221853 — OTC DDRKonica Minolta Healthcare Americas, Inc. Jul 27, 2022
K221254 — Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. Jul 27, 2022
K210822 — DeepRhythmAIMedicalgorithmics S.A. Jul 27, 2022
K220876 — AOK 95A Medical Mask (20200049)Aok Tooling Limited Jul 27, 2022
K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitCochlear Americas Jul 27, 2022
K221856 — BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc. Jul 27, 2022
K221567 — LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)Qingdao Hisense Medical Equipment Co., Ltd. Jul 26, 2022
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