510(k) Clearances

174,759 clearances total

K253775 — SwiftMRAirs Medical, Inc. Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253680 — LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252037 — CUVIS-joint (CJ150)Curexo, Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)Medline Industries, LP Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252052 — Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253615 — Invictus Bands SystemAlphatec Spine, Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen NeedleSandstone Medical (Suzhou), Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252432 — Flex-Z™ Cervical CageSpinepoint, LLC Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254278 — Arterial Pressure Monitoring Set/TraySpectrum Vascular Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260274 — Airlock® Ankle Plating SystemNovastep SAS Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260291 — Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252023 — MiraChlor Antimicrobial Wound SolutionLetus Corporation Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254012 — Electric Wheelchair (E201)Nanjing CareMoving Rehabilitation Equipment Co.,Ltd Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260787 — FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253047 — PRESSONE™Nipro Medical Corporation Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252169 — Access BNP IIBeckman Coulter, Inc. Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253198 — NanoKnife Generator (H78720300351US0)Angiodynamics Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerGE Medical Systems Ultrasound and Primary Care Diagnostics Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254253 — LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252421 — JLK-NCCTJLK, Inc. Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252099 — TriniasShimadzu Corporation Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCS Tue Mar 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252031 — Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd. Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254166 — MDx-Chex for BCNStreck Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260202 — LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd. Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252992 — CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260112 — QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254288 — Clavicle Fixation SystemSkeletal Dynamics, Inc. Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253686 — True Definition DLGe Healthcare Japan Corporation Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254275 — HyperSuture All Green Extension LineThreadstone, LLC Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253604 — TiLink-L Navigation InstrumentsSurGenTec, LLC Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253574 — SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253849 — Electric wheelchair (JJW-7002, JJW-7003)ZheJiang J&J Mobility Co., Ltd. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251980 — ClaveQS™ BagIcu Medical, Inc. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252606 — Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260437 — Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253520 — Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254170 — Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251937 — nordicAudio (1.0)Nordicneurolab AS Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254208 — FLOWRUNNER Aspiration SystemExpanse Medical, Inc. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260551 — HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260561 — Arthrex FiberTak Suture AnchorArthrex, Inc. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252016 — Arthrex Humeral NailsArthrex, Inc. Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252358 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253098 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253864 — NOMAD Pro 3Dental Imaging Technologies Corporation Fri Mar 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
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