510(k) Clearances — Page 88
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250021 — Rotium | Nanofiber Solutions, LLC Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241620 — ChestView US | Gleamer Sas Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241550 — Gelweave Vascular Prostheses | Vascutek, Ltd. Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243543 — microINR System | Iline Microsystems, S.L. Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241586 — PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242900 — VADER® Pedicle System and VADER®one Pedicle System | Icotec AG Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242128 — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242175 — XOD Diathermia Radiofrequency Device | Xod, Inc. Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241576 — Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Infraredx, Inc. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241587 — pilot TLS | Vygon Corporation Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250202 — Aventus Thrombectomy System | Inquis Medical Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | SteriLance Medical (Suzhou), Inc. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241222 — Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics , Ltd. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244036 — Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243918 — Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250346 — BonVie+ | Elute, Inc. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250281 — DEKA LOTUS | El.En S.P.A. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241546 — aiCockpit AI Viewer | Fovia, Inc. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250012 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. Wed Feb 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242967 — Loss of Pulse Detection | Fitbit Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery, LLC Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250238 — WasherCap Fixation System | Abanza Tecnomed S.L Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242822 — ART-Plan+ (v.3.0.0) | Therapanacea Sas Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233963 — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241601 — EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250348 — JLK-AILink | JLK, Inc. Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250223 — BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243446 — 3DXR | GE Medical Systems SCS Tue Feb 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244010 — ExamVue Apex | Jpi Healthcare Co, Ltd. Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241565 — Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243035 — Ulthera® System | Ulthera, Inc. Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241703 — SD Implant System | Arum Dentistry Co., Ltd. Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243823 — Control-IQ+ technology | Tandem Diabetes Care, Inc. Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242994 — OncoStudio (OS-01) | Oncosoft. Co., Ltd. Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243287 — APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243431 — Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242850 — Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243614 — Sonio Suspect | Sonio Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243916 — Primus Spinal Fixation System | Spinal Elements, Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243940 — VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243115 — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250218 — Xpert® FII & FV | Cepheid Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242607 — ScanDiags Ortho L-Spine MR-Q | Scandiags AG Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |