510(k) Clearances in 2022 — Page 50

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 50 of 65)
510(k) clearancesDetails
K213783 — ApyxEscala Medical Apr 5, 2022
K212624 — EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. Apr 4, 2022
K213388 — AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemAngioDynamics, Inc. Apr 4, 2022
K212126 — MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc. Apr 4, 2022
K220022 — TRATE Dental Implant SystemTrate AG Apr 4, 2022
K214006 — Invictus® Spinal Fixation SystemAlphatec Spine, Inc. Apr 4, 2022
K213282 — ERI Handheld Dental X-ray System (Model AG100)Energy Resources International Co., Ltd. Hsinchu Branch Apr 4, 2022
K213604 — ELAZ Nitrile Powder Free Examination GloveProtect Gloves Co., Ltd. Apr 3, 2022
K220066 — Medical Nitrile Examination GlovesHunan Zhenheyikang Medical Instrument Co., Ltd. Apr 3, 2022
K212947 — Trinity Plus Wrinkle ReducerCarol Cole Company Dba Nuface Apr 2, 2022
K220343 — Nitrile Examination GlovesNb Medical Co., Ltd. Apr 2, 2022
K211882 — HD-550 Video Endoscope SystemSonoscape Medical Corp. Apr 1, 2022
K210052 — Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))Saneso, Inc. Apr 1, 2022
K213490 — Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. Apr 1, 2022
K212184 — TENS and EMS Stimulation (OTC)Changsha Yuwen Medical Equipment Co., Ltd. Apr 1, 2022
K220668 — Wireless Digital Flat Panel DetectorIray Technology Taicang , Ltd. Apr 1, 2022
K213494 — Aveir Retrieval CatheterABBOTT MEDICAL Apr 1, 2022
K213793 — EMPOWR Revision KneeEncore Medical L.P. Apr 1, 2022
K220518 — SKANRAD 400Skanray Technologies Limited Apr 1, 2022
K213118 — Dakota ALIF SystemPrecision Spine, Inc. Apr 1, 2022
K220151 — MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc. Apr 1, 2022
K213432 — MIS Angulated multi-unit abutmentsDentsply Sirona Apr 1, 2022
K213657 — DEEPVESSEL FFRKeyamed Na, Inc. Apr 1, 2022
K212216 — Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation Apr 1, 2022
K213552 — PuraStat-RM3-D Matrix, Inc. Apr 1, 2022
K212392 — Intri24 SheathInari Medical, Inc. Apr 1, 2022
K220601 — CoolToneZimmer Medizinsysteme GmbH Apr 1, 2022
K210558 — LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberThayer Medical Corporation Apr 1, 2022
K220005 — TENS & PMS UnitShenzhen Yuehua Xinsen Technology Co., Ltd. Apr 1, 2022
K220025 — ARx® Spinal SystemLife Spine, Inc. Mar 31, 2022
K220291 — NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC Mar 31, 2022
K220584 — BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. Mar 31, 2022
K220240 — Vinyl Co-Polymer Powder-free Examination Gloves, BlackGrand Work Plastic Products Co., Ltd. Mar 31, 2022
K214057 — STATIM 6000B Vacuum AutoclaveScican , Ltd. Mar 31, 2022
K210546 — Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics Mar 31, 2022
K220202 — Uterine ElevatOR PRO with OccludOR BalloonThe O R Company Pty, Ltd. Mar 31, 2022
K220260 — Hercules Syndesmosis Implant SystemIn2Bones USA, LLC Mar 31, 2022
K220353 — Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy DrugsNiujian Technology Co., Ltd. Mar 31, 2022
K220678 — APX-24 Portable X-ray SystemAspenstate, Inc. Mar 31, 2022
K212894 — PhasTIPPLeMaitre Vascular, Inc. Mar 31, 2022
K211043 — Alexis Contained Extraction SystemApplied Medical Resources Corporation Mar 31, 2022
K213843 — Nitrile Examination GlovesDong Tai City Huayi Gloves Co., Ltd. Mar 31, 2022
K213736 — Medical Face MaskHangzhou Runheng Medical Co., Ltd. Mar 31, 2022
K220160 — PediGuard ThreadedSpineguard S.A. Mar 31, 2022
K220674 — TargetCoolRecensmedical, Inc. Mar 31, 2022
K212888 — Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures Mar 31, 2022
K211120 — ERIC Retrieval DeviceMicroVention, Inc. Mar 31, 2022
K213745 — Air Compression Therapy Device, model: ST-502Shenzhen Future Electronic Co., Ltd. Mar 31, 2022
K220182 — Aggeris™-CClariance Mar 30, 2022
K220213 — Empulse R90Sunrise Medical (Us), LLC Mar 30, 2022
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