510(k) Clearances in 2023 — Page 52

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 52 of 67)
510(k) clearancesDetails
K221493 — MicroScan Prompt Inoculation System-DBeckman Coulter, Inc. Apr 5, 2023
K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification SystemMedtronic, Inc. Apr 5, 2023
K230107 — Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products , Ltd. Apr 5, 2023
K223256 — Optimos™ CystotomeTaewoong Medical Co., Ltd. Apr 5, 2023
K230033 — Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. Apr 5, 2023
K230385 — Ballancer Platinum (1222)Mego Afek Apr 4, 2023
K213584 — Reprocessed NRG Transseptal NeedleInnovative Health, LLC Apr 4, 2023
K230029 — NeuroStar Advanced Therapy System (Version 3.7)Neuronetics Apr 4, 2023
K220142 — BRM Digitalis SpacerBrm Extremities Srl Apr 4, 2023
K220454 — Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile ApplicationAvation Medical, Inc. Apr 3, 2023
K213749 — G7, Dental Operative Unit and AccessoriesShinhung Company, Ltd. Apr 3, 2023
K223240 — Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty , Ltd. Apr 3, 2023
K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)Mawi Dna Technologies Apr 3, 2023
K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyCardinal Health200, LLC Apr 3, 2023
K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy NeedleCanyon Medical, Inc. Apr 3, 2023
K222006 — Sclerotherapy & Endoscopic NeedlesG-Flex Europe Sprl Apr 3, 2023
K222370 — SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd. Apr 2, 2023
K221734 — Maxtec MaxO2 ME+pMaxtec, LLC Apr 1, 2023
K230568 — FiberTak Suture AnchorArthrex, Inc. Apr 1, 2023
K230312 — Iris AirShuttle™Qfix Mar 31, 2023
K230003 — Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankTopzir Biotech Co., Ltd. Mar 31, 2023
K223778 — Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd. Mar 31, 2023
K211059 — CereFlow™ V1.2Translational Mri, LLC Mar 31, 2023
K230605 — 1788 4K Camera System with Advanced Imaging ModalityStryker Mar 31, 2023
K230021 — IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd. Mar 31, 2023
K230238 — BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup RxShenzhen Bioeasy Biotechnology Co., Ltd. Mar 31, 2023
K230274 — Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. Mar 31, 2023
K213272 — Formus HipFormus Labs, Ltd. Mar 31, 2023
K230356 — Aspirex™ Thrombectomy SystemC.R. Bard, Inc. Mar 31, 2023
K230022 — Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation Mar 31, 2023
DEN200011 — Masimo SafetyNetMasimo Corporation Mar 31, 2023
K223570 — SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd. Mar 31, 2023
K230041 — Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation Mar 31, 2023
K220068 — Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. Mar 31, 2023
K220780 — ROVO Mechanical Thrombectomy Device2Mg, Inc. Mar 31, 2023
K223017 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation Mar 31, 2023
K213660 — RadAllyImaging Wave, LLC Mar 31, 2023
K221320 — Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXNidek Co., Ltd. Mar 30, 2023
K223377 — BIASURGE Advanced Surgical SolutionRochal Technologies, LLC Mar 30, 2023
K223422 — Emory Cardiac Toolbox 4.3Syntermed Mar 30, 2023
K230590 — ARDO BellisArdo Medical AG Mar 30, 2023
DEN210039 — SNOO Smart SleeperHappiest Baby, Inc. Mar 30, 2023
K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical) Mar 30, 2023
K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies Mar 30, 2023
K223923 — HOPKINS TelescopesKARL STORZ Endoscopy-America, Inc. Mar 30, 2023
K223342 — MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion SystemCrossroads Extremity Systems, LLC Mar 30, 2023
K230161 — ONLINE TDM Phenytoin - Free Phenytoin applicationRoche Diagnostics Mar 30, 2023
K230636 — Maestro MicrocatheterMerit Medical System, Inc. Mar 30, 2023
K220088 — Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl CitrateProfessional Latex Sdn Bhd Mar 30, 2023
K230555 — Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc. Mar 30, 2023
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