510(k) Clearances in 2022 — Page 9

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 9 of 65)
510(k) clearancesDetails
K221178 — Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd. Nov 17, 2022
K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusConvatec, Inc. Nov 17, 2022
K220558 — Blood Administration SetsBaxter Healthcare Corporation Nov 17, 2022
K213042 — Supra Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH Nov 17, 2022
K220905 — xvision Spine SystemAugmedics, Ltd. Nov 17, 2022
K221281 — Multitom RaxSiemens Medical Solutions Nov 17, 2022
K223227 — MAVEN™ Patient-Specific InstrumentationParagon 28, Inc. Nov 17, 2022
K220042 — Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc. Nov 17, 2022
K222973 — IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody SytemAlphatec Spine, Inc. Nov 17, 2022
K211265 — TFX-LT2000 Therapy LightToefx, Inc. Nov 17, 2022
K213295 — C.C. LIFE 2121 Equipment S.R.L. Nov 17, 2022
K223278 — easy ClaireY & J Bio Co., Ltd. Nov 17, 2022
K222598 — IPL Hair Removal DeviceShenzhen Noble Smart Manufacturing Tech Co., Ltd. Nov 17, 2022
K222476 — OmegaAI Image ViewerRamsoft, Inc. Nov 17, 2022
K222109 — Accure LaserAccure Acne, Inc. Nov 17, 2022
K222673 — Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser) Nov 17, 2022
K220739 — Disposable Urine Collection TubeZhejiang Gongdong Medical Technology Co., Ltd. Nov 17, 2022
K212910 — Dental High-speed Turbine Handpiece, Dental Low-speed Turbine HandpieceShenzhen Carejoy Technology Co., Ltd. Nov 17, 2022
K223267 — SKR 3000Konica Minolta, Inc. Nov 17, 2022
K222208 — Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd. Nov 17, 2022
K220841 — PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona Nov 16, 2022
K221094 — OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona Nov 16, 2022
K220302 — Disposable surgical face maskShandong Aida Medical Products Co., Ltd. Nov 16, 2022
K222628 — Life Spine ALIF Buttress Plate SystemLife Spine, Inc. Nov 16, 2022
K220533 — Endoscopy Oxygen MaskEngineered Medical Systems, Inc. Nov 16, 2022
K220465 — PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10Pentax Of America, Inc. Nov 16, 2022
K212812 — Surgical GownXianning Marveldas Protective Articles Co., Ltd. Nov 16, 2022
K220635 — Heater-Cooler System 3TLivanova Deutschland, GmbH Nov 16, 2022
K222364 — Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)Xtrallux, LLC Nov 16, 2022
K203528 — KNH Surgical Face MaskKnh Surgical Face Mask Nov 16, 2022
K221762 — BoneMRI v1.4Mrlguidance B.V. Nov 16, 2022
K222564 — Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc. Nov 15, 2022
K221558 — ALPHALOK Plating SystemVilex, LLC Nov 15, 2022
K211830 — LifeSPARC SystemCardiacassist, Inc. Nov 15, 2022
K222055 — Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. Nov 15, 2022
K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. Nov 15, 2022
K222488 — Everyway Analog OTC TENSEveryway Medical Instruments Co.,Ltd Nov 15, 2022
K220535 — Cardio10Bionet Co., Ltd. Nov 15, 2022
K222309 — Gamma4 SystemStryker GmbH Nov 15, 2022
K222915 — Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUSCanadian Pioneer Medical Technology Corporation (Cpmt Laser) Nov 15, 2022
K212612 — Omnia Medical TiBrid-SCOmnia Medical, LLC Nov 15, 2022
K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation Nov 15, 2022
K223199 — 2.1 x 255mm Drill, 22mm StopBiomet Microfixation Nov 15, 2022
K212700 — Dyflex-IITaeyeon Medical Co., Ltd. Nov 15, 2022
K222175 — Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. Nov 15, 2022
K222529 — Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. Nov 14, 2022
K222520 — Zirconia BlockYilink (Tianjin) Biotechnology Co., Ltd. Nov 14, 2022
K221655 — Multiflex Steerable SheathVizaramed, Inc. Nov 14, 2022
K213217 — Disposable hemoclipBeijing Zksk Technology Co., Ltd. Nov 14, 2022
K222480 — Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)Foshan Nanhai Plus Medical Co, Ltd. Nov 14, 2022
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