510(k) Clearances

174,759 clearances total

K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance , Ltd. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253169 — Duet™ Spinal Fixation SystemBox Spine, LLC Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251587 — VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)Applied Medical Resources Corporation Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251864 — Rubber Utility CatheterC.R. Bard, Inc. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251661 — Mariana Minerva; Mariana NimbusResmed Pty , Ltd. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. Sun Feb 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251692 — Advanced Tissue Resection DeviceMicro-Tech (Nanjing) Co., Ltd. Sat Feb 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252619 — QSCHECK UISACRQstag, Inc. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252672 — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253660 — KLS Martin Pure Pectus SystemKLS-Martin L.P. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251653 — SPRY TMS Therapy System (0550)Soterix Medical, Inc. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254162 — KLS Martin Ixos SystemKLS Martin L.P. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253653 — Xpert Hemorrhagic FeverCepheid Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252500 — CARA SystemCara Medical, Ltd. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253605 — Safety Heel LancetNingbo Medsun Medical Co., Ltd. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252972 — CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252989 — “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260181 — LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253683 — FAQ™ (LED Panel); FAQ™ (Dual LED Panel)Foreo, Inc. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251890 — Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd. Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260163 — AuST CSP IntroducerCenterPoint Systems, LLC Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254188 — Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air MotorStryker Leibinger GmbH & Co KG Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260205 — AS Software Version AseraAS Software, LLC Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254018 — Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253687 — Access anti-HBc TotalBeckman Coulter, Inc. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252733 — ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253612 — Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K254148 — VERTICALE GPS InstrumentsSilony Medical GmbH Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260218 — LacertaMatrixLacerta Life Sciences Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K251903 — Erchonia DPN Laser (Model# EVRL)Erchonia Corporation Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253002 — SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260308 — TrueFit BolusAdaptiiv Medical Technologies, Inc. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253203 — Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252814 — Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd. Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252002 — Monaco RTP System (6.3)Elekta Solutions AB Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253643 — Mobility Scooter (S3)Shenzhen Zhimahuaerkai Technology Co., Ltd. Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252197 — Nobel Biocare S Series ImplantsNobel Biocare AB Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252561 — BTL-754FFBTL Industries, Inc. Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253539 — Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd. Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd. Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
K253524 — Adaptos®Fuse Bone GraftBiomendex OY Tue Feb 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
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