510(k) Clearances — Page 148

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 148 of 3,525)
ClearancesDetails
K233885 — rainbow Paste Stain SEGenoss Co., Ltd. Jun 21, 2024
K240631 — V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jun 21, 2024
K240387 — MINAMO blue; MINAMO violaAsahi Intecc Co., Ltd. Jun 21, 2024
K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)Owens & Minor (O&M) Halyard, Inc. Jun 21, 2024
K233096 — PRESSUREALERT® Pressure Monitoring SystemPosition Health, LLC Jun 21, 2024
K233876 — UNITY VCS (8065000296); UNITY CS (8065000297)Alcon Laboratories, Inc. Jun 21, 2024
K233549 — Tempus ECG-AFTempus AI, Inc. Jun 21, 2024
K241442 — eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd. Jun 21, 2024
K233253 — eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc. Jun 21, 2024
K233280 — SteadyTempSteadysense GmbH Jun 21, 2024
K234095 — OtoNova/OtoNova ProOtodynamics Jun 21, 2024
K233230 — See Factor CT3™Epica International, Inc. Jun 21, 2024
K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)Guangzhou Red Pine Medical Instrument Co., Ltd. Jun 21, 2024
K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamGuangzhou Decheng Biotechnology Co., Ltd. Jun 21, 2024
K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc. Jun 21, 2024
K232975 — Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd. Jun 21, 2024
K233361 — Sunny Cup and ApplicatorMenstrual Mates Jun 21, 2024
K233322 — Mochida Nerve CuffMochida Pharmaceutical Co., Ltd. Jun 21, 2024
K240125 — Therm-X (Home); Therm-X (AT)Zenith Technical Innovations Jun 21, 2024
K240830 — Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody SystemOrthofix Medical, Inc. Jun 20, 2024
K240673 — Electric wheelchairZhejiang Hfizer Medical Equipment Co., Ltd. Jun 20, 2024
K241435 — Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blueSmith & Nephew, Inc. Jun 20, 2024
K233158 — Copra Smile, Copra Supreme HyperionWhitepeaks Dental Solutions GmbH Jun 20, 2024
K240669 — ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc. Jun 20, 2024
K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation Jun 20, 2024
K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc. Jun 20, 2024
K241627 — Safety Lancet (XXXV)Tianjin Huahong Technology Co., Ltd. Jun 20, 2024
K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC Jun 20, 2024
K240611 — IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd Jun 20, 2024
K233162 — Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix Jun 20, 2024
K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)Schoelly Fiberoptic GmbH Jun 20, 2024
K240642 — SMART Bun-Yo-Matic CTDisior, Ltd. Jun 20, 2024
K240613 — APTUS Elbow Dorsal Olecranon PlatesMedartis AG Jun 20, 2024
K240688 — RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak Jun 20, 2024
K232161 — DeepRhythm PlatformMedicalgorithmics S.A. Jun 20, 2024
K232997 — EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation Jun 19, 2024
K240774 — Pen InjectorWuxi Nest Biotechnology Co., Ltd. Jun 18, 2024
K240196 — Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)Yuwonmeditech Co., Ltd. Jun 18, 2024
K233036 — Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd. Jun 18, 2024
K241412 — Invisalign SystemAlign Technology, Inc. Jun 18, 2024
K233294 — Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH Jun 18, 2024
K240678 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP TechnologyDepuy Ireland UC Jun 18, 2024
K240552 — Irrisept Antimicrobial Wound LavageIrrimax Corporation Jun 18, 2024
K233867 — Fitbone TrochantericOrthofix Srl Jun 18, 2024
K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterThayer Medical Corporation Jun 18, 2024
K240583 — IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. Jun 18, 2024
K233331 — MediOMxPmx, Inc. Jun 17, 2024
K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd. Jun 17, 2024
K232258 — XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC Jun 17, 2024
K240747 — Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd. Jun 17, 2024
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