510(k) Clearances in 2022 — Page 14

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 14 of 65)
510(k) clearancesDetails
K222270 — HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS InstrumentsGlobus Medical, Inc. Oct 21, 2022
K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated Oct 21, 2022
K221643 — Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd. Oct 21, 2022
K222215 — IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. Oct 21, 2022
K222632 — UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics Oct 21, 2022
K221992 — Electronic Pulse StimulatorBeijing Choice Electronic Technology Co., Ltd. Oct 21, 2022
K222141 — Safety Blood Collection Needle (Without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Oct 21, 2022
K213128 — IntraOp VSP Software DeviceXironetic, LLC Oct 21, 2022
K220165 — Enteral Transition AdaptorGBUK Group, Ltd. Oct 21, 2022
K220273 — Onetouch Non-paraben Lubricant GelThai Nippon Rubber Industry Public Company Limited. Oct 21, 2022
K222827 — da Vinci Firefly Imaging SystemIntuitive Surgical, Inc. Oct 20, 2022
K222842 — V-Patch Cardiac MonitorShandong Corecare Technology Limited Oct 20, 2022
K222886 — Mercu 1717VIray Technology Taicang , Ltd. Oct 20, 2022
K213106 — BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. Oct 20, 2022
K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelBiofire Defense, LLC Oct 20, 2022
K221947 — Tyber Medical Staple Fixation System (various)Tyber Medical, LLC Oct 20, 2022
K213466 — Houdini Cross Support CatheterCruzar Medsystems, Inc. Oct 20, 2022
K221740 — SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)Smith And Nephew, Inc. Oct 20, 2022
K220099 — eClinic StethopodHomediagnostic, LLC Oct 20, 2022
K222404 — Evo® sEEG SystemNeuroone Medical Technologies Corp. Oct 20, 2022
K214073 — eWave MonitorWearlinq, Inc. Oct 20, 2022
K220527 — PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix Oct 20, 2022
K213429 — AccuSert Needle InserterEmed Technologies Corporation Oct 20, 2022
K222361 — AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. Oct 20, 2022
K222547 — Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd Oct 20, 2022
K221977 — Disposable Surgical Gown (G4003)Xiantao Topmed Nonwoven Protective Products Co., Ltd. Oct 20, 2022
K222856 — SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. Oct 19, 2022
K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation PlateStryker Corporation Oct 19, 2022
K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc. Oct 19, 2022
K222890 — RADIANCE ULTRA 32 4K ZEROWIRE DUONds Surgical Imaging, LLC Oct 19, 2022
K211409 — Proximerge 2 Dental Implant SystemQuadric Biomed, LLC Oct 19, 2022
K213742 — Infinity Pro, Logic, Quality, SprintOlsen Indústria E Comércio S.A. Oct 19, 2022
K221795 — STERN FIX Sternal Stabilization SystemNeos Surgery S.L Oct 19, 2022
K220992 — Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleEver Global (Vietnam) Enterprise Corporation Oct 19, 2022
K221032 — Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc. Oct 19, 2022
K222643 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V. Oct 19, 2022
K222657 — MEBO Wound DressingMebo Life Science, Inc. Oct 18, 2022
DEN220024 — ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited Oct 18, 2022
K221986 — XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC Oct 18, 2022
K213978 — TELIGEN SystemMedos International SARL Oct 18, 2022
K213123 — EVOS Wrist Spanning PlateSmith & Nephew, Inc. Oct 18, 2022
K222298 — Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric AcidOnetexx Sdn Bhd Oct 18, 2022
K222203 — DualXSLIM(R) T/PLIFAmplify Surgical, Inc. Oct 18, 2022
K222572 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate SystemDio Medical Corporation Oct 18, 2022
K221072 — TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health Oct 18, 2022
K222721 — Violet Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited Oct 18, 2022
K222167 — E-Z Chek Chlorine Residual Test Strips (K100-0101B)Reprocessing Products Corporation (Rpc) Oct 18, 2022
K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. Oct 18, 2022
K221632 — Spine CAMP™Medical Metrics, Inc. Oct 18, 2022
K203549 — Nova Primary Glucose Analyzer SystemNova Biomedical Corporation Oct 18, 2022
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