510(k) Clearances in 2022 — Page 52

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 52 of 65)
510(k) clearancesDetails
K212916 — Black Nitrile Powder Free Patient Examination Glove, Non SterileRimba Glove Sdn Bhd Mar 24, 2022
K220207 — Mobility Scooter, Model W3468Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Mar 24, 2022
K220354 — Disposable Medical Synthetic Nitrile Examination GlovesNiujian Technology Co., Ltd. Mar 24, 2022
K220655 — X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. Mar 24, 2022
K213461 — AviClear Laser SystemCutera, Inc. Mar 24, 2022
K220519 — Erchonia Zerona Z-BedErchonia Corporation Mar 24, 2022
K211365 — Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio Mar 24, 2022
K213616 — BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson And Company Mar 23, 2022
K213592 — Iridex 810 LaserIridex Corporation Mar 23, 2022
K212626 — PathBuilder Transseptal Guiding IntroducerShanghai Microport EP Medtech Co., Ltd. Mar 23, 2022
K214101 — Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited Mar 23, 2022
K210718 — LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber DressingHuizhou Foryou Medical Devices Co., Ltd. Mar 23, 2022
K212726 — Disposable Medical Surgical MaskHubei Huaqiang High-Tech Co., Ltd. Mar 23, 2022
K212625 — PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd. Mar 23, 2022
K220492 — COPAL exchange G hip spacerHeraeus Medical GmbH Mar 23, 2022
K213568 — DRX-Rise Mobile X-ray SystemCarestream Health Mar 23, 2022
K220501 — Pounce Thrombectomy SystemSurmodics,Inc. Mar 23, 2022
K220178 — Total Immunoglobulin E (IgE)Beckman Coulter, Inc. Mar 23, 2022
K213860 — ArthroFree Wireless Surgical Camera SystemLazurite Holdings, LLC Mar 23, 2022
K220181 — StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. Mar 22, 2022
K212960 — Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation Mar 22, 2022
K220511 — Medline UNITE IM Fibula ImplantMedline Industries, LP Mar 22, 2022
K214039 — LOGIQ P10, LOGIQ P9, LOGIQ P8GE Medical Systems Ultrasound And Primary Care Diagnostics Mar 22, 2022
K213522 — AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. Mar 22, 2022
K214103 — Shani Darden LED light therapy maskHarpar Grace International Mar 22, 2022
K210693 — PLEXR PLUSGmv S.R.L. Mar 22, 2022
K213678 — Powder Free Blue Nitrile Examination GlovesLienteh Technology Sdn Bhd Mar 22, 2022
K210452 — Creatinine2Abbott Ireland Diagnostics Division Mar 22, 2022
K200828 — Athelas HomeAthelas, Inc. Mar 22, 2022
K203839 — WatchPAT200U (WP200U)Itamar Medical , Ltd. Mar 21, 2022
K213721 — BriefCaseAidoc Medical , Ltd. Mar 21, 2022
K212999 — Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd. Mar 21, 2022
K213200 — Solus Gold Embolization DeviceArtio Medical, Inc. Mar 21, 2022
K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongMedtronic Xomed, Inc. Mar 21, 2022
K220199 — AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. Mar 21, 2022
K220627 — SURGIVISIO DeviceEcential Robotics Mar 18, 2022
K212939 — Vintage Prime PressShofu Dental Corporation Mar 18, 2022
K213965 — BeautiBond XtremeShofu Dental Corporation Mar 18, 2022
K214016 — 15L Cycler Drainage BagBaxter Healthcare Corporation Mar 18, 2022
K212371 — F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd. Mar 18, 2022
K212498 — Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC Mar 18, 2022
K211132 — ARISTE AB MeshAriste Medical, LLC Mar 18, 2022
K220228 — Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy DrugsShandong Blue Sail Health Technology Co., Ltd. Mar 18, 2022
K220473 — CELERITY 20 HP Challenge PackSteris Mar 18, 2022
K220153 — Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd. Mar 18, 2022
K203237 — Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical GownDukal Corporation Mar 18, 2022
K213834 — Cardio Flow Peripheral Guide WireCardio Flow Inc., Mar 18, 2022
K213563 — DePuy Synthes Radial Head Replacement SystemDePuy Synthes Mar 18, 2022
K212891 — TempSure SystemCynosure, LLC Mar 18, 2022
K210171 — Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)Sichuan Youkede Medical Equipment Co.,Ltd Mar 18, 2022
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