510(k) Clearances in 2022 — Page 10

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 10 of 65)
510(k) clearancesDetails
K222490 — HBL Blade AssemblyHand Biomechanics Lab, Inc. Nov 14, 2022
K210980 — Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. Nov 14, 2022
K222749 — High Fluid-Resistant Surgical and Procedure MaskAmerica’S Supply Chains Nov 14, 2022
K222428 — Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. Nov 14, 2022
K221578 — Hexanium ACIFSpinevision, S.A.S. Nov 14, 2022
K222540 — uPMR 790Shanghai United Imaging Healthcare Co., Ltd. Nov 14, 2022
K220326 — PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC Nov 14, 2022
K213981 — Nitrile Examination GlovesEmerald Glove Manufacturing Sdn Bhd Nov 12, 2022
K222225 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)Hartalega NGC Sdn. Bhd. Nov 11, 2022
K212164 — Mapping Suction ProbeInomed Medizintechnik GmbH Nov 11, 2022
K220983 — ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc. Nov 11, 2022
K221391 — WOLF Thrombectomy™ SmartClaw CatheterDevoro Medical, Inc. Nov 10, 2022
K222067 — SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. Nov 10, 2022
K222475 — SNOR LOCKSolbaro Co., Ltd. Nov 10, 2022
K213294 — Dermal Cooling SystemR2 Technologies, Inc. Nov 10, 2022
K220957 — FUJIFILM Endoscope Model EB-710PFujifilm Corporaton Nov 10, 2022
K222667 — Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxVivachek Biotech (Hangzhou) Co., Ltd. Nov 10, 2022
K222551 — Humask Pro Vision, Humask Pro Vision 3000Entreprise Premont, Inc. Nov 10, 2022
K221139 — Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Nov 10, 2022
K221678 — SprintRay High Impact Denture BaseSprintray, Inc. Nov 10, 2022
K222504 — H1Karl Storz Endoscopy America, Inc. Nov 10, 2022
K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridSpes Medica Srl Nov 10, 2022
K222317 — Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. Nov 10, 2022
K221183 — AEYE-DSAeye Health, Inc. Nov 10, 2022
K220230 — AMSure Enteral Feeding PumpAmsino International, Inc. Nov 10, 2022
K220408 — AVIEW RT ACSCoreline Soft Co., Ltd. Nov 10, 2022
K220562 — TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd. Nov 10, 2022
K223198 — BD Intraosseous Vascular Access System EMS Powered Driver (D001003)Bard Access Systems Nov 10, 2022
K220794 — 10PLTentech Co. , Ltd. Nov 10, 2022
K221677 — Synapse 3D Base Tools v6.6Fujifilm Corporation Nov 10, 2022
K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc. Nov 10, 2022
K223171 — AquaPulse® Irrigation TubingGa Health Company Limited Nov 10, 2022
K223185 — BreathID® Smart SystemMeridian Bioscience Israel , Ltd. Nov 10, 2022
K220360 — Tandry CMF Plate SystemMicroware Precision Co., Ltd. Nov 10, 2022
K222061 — Dental LT Clear V2 ResinFormlabs Ohio, Inc. Nov 10, 2022
K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenbergBoston Scientific Corporation Nov 10, 2022
K222162 — Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd. Nov 9, 2022
K222754 — ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Nov 9, 2022
K222166 — SOLIXOptovue, Inc. Nov 9, 2022
K221539 — GammaTileGt Medical Technologies Nov 9, 2022
K222198 — Exo Iris (El2001)Exo Imaging, Inc. Nov 9, 2022
K203035 — Eonis SCID-SMA kitPerkinelmer, Inc. Nov 9, 2022
K222497 — Zaga Zygomatic SystemSouthern Implants (Pty), Ltd. Nov 9, 2022
K223132 — Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation Nov 9, 2022
K220334 — MONET Anterior Cervical Plate SystemCtl Medical Corporation Nov 9, 2022
DEN200044 — Eonis SCID-SMA KitPerkinelmer, Inc. Nov 9, 2022
K221855 — Universal CMF SystemStryker Leibinger GmbH & Co KG Nov 9, 2022
K223178 — SelectSite C304 Deflectable Catheter System, C315 Delivery SystemMedtronic Nov 8, 2022
K210346 — Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc. Nov 8, 2022
K221552 — EFAI ChestSuite XR Pneumothorax Assessment SystemEver Fortune.Ai, Co., Ltd. Nov 8, 2022
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