510(k) Clearances in 2025 — Page 52

3,225 510(k) clearances total

Browse FDA 510(k) clearances granted in 2025. RegDataLab tracks 3,225 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2025 (page 52 of 65)
510(k) clearancesDetails
K243980 — ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited Mar 21, 2025
K242888 — Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Mar 21, 2025
K243958 — Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments Mar 21, 2025
K250517 — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006Boston Scientific Corporation Mar 21, 2025
K250556 — Porous Biologic ScaffoldVentris Medical Mar 21, 2025
K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)Casebioscience, Inc. Mar 21, 2025
K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC Mar 21, 2025
K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060)Yukon Medical, LLC Mar 21, 2025
K243451 — FiAPC plus probesErbe Elektromedizin GmbH Mar 21, 2025
K250403 — Catamaran SI Joint Fusion SystemTenon Medical Mar 21, 2025
K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC Mar 21, 2025
K241833 — V-GRADVitromed GmbH Mar 21, 2025
K243630 — Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc Mar 21, 2025
K243649 — BD Vacutainer® Multiple Sample Luer AdapterBecton, Dickinson And Company Mar 21, 2025
K250561 — Natural CyclesNatural Cycles Nordic AB Mar 21, 2025
K241065 — ChecQ (AC100)Dentis Co., Ltd. Mar 21, 2025
K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped MicrocatheterStryker Neurovascular Mar 21, 2025
K243808 — Rayvolve PTX-PEAZmed Mar 21, 2025
K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Mar 21, 2025
K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)Prismatik Dentalcraft, Inc. Mar 21, 2025
K250186 — GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA Mar 21, 2025
K250513 — IntelliSep Test (CV-ICG-048)Cytovale, Inc. Mar 21, 2025
K250106 — Signos Glucose Monitoring SystemSignos, Inc. Mar 21, 2025
K243185 — REMI Remote EEG Monitoring SystemEpitel Mar 21, 2025
K241890 — Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH Mar 21, 2025
K241961 — Vent Creativity Knee v1.0 (Hermes)Vent Creativity Mar 20, 2025
K241884 — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)Hunan Haipuming Technology Co., Ltd. Mar 20, 2025
K243988 — RootMend MRRRiverpoint Medical, LLC Mar 20, 2025
K250463 — Ameda GLO Wearable Breast Pump (Model W8S)Shenzhen TPH Technology Co., Ltd. Mar 20, 2025
K243975 — Knee+Pixee Medical Mar 20, 2025
K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PGDRTECH Corporation Mar 20, 2025
K243922 — RevogeneMeridian Bioscience, Inc. Mar 20, 2025
K242771 — Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. Mar 20, 2025
K243928 — ViaOne Epicardial Access SystemCardiovia , Ltd. Mar 20, 2025
K250468 — iSLEEVE Introducer SetBoston Scientific Mar 20, 2025
K243292 — brAIn™ Shoulder PositioningAvatar Medical Mar 20, 2025
K243016 — Starlight Imaging CatheterSpectrawave, Inc. Mar 20, 2025
K242958 — Joylux Intimacy Gel (PG3100)Joylux, Inc. Mar 20, 2025
K241704 — Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. Mar 20, 2025
K241842 — Luer-Split MAJ-2092Olympus Medical Systems Corporation Mar 19, 2025
K243999 — TriMed Ankle Fixation SystemTriMed, Inc. Mar 19, 2025
K250502 — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)Safesource Direct, LLC Mar 19, 2025
K250429 — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH setMacromedics BV Mar 19, 2025
K250171 — IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd. Mar 19, 2025
K243472 — 1NEED ProCampomats S.R.L. Mar 19, 2025
K241791 — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)Gigaalaser Company , Ltd. Mar 19, 2025
K243987 — TriMed Elbow and Forearm SystemTriMed, Inc. Mar 19, 2025
K243092 — AcuPebble Ox (200)Acurable Limited Mar 19, 2025
K250131 — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)Mustech Electronics Co., Limited Mar 19, 2025
K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))Scivita Medical Technology Co., Ltd. Mar 19, 2025
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