510(k) Clearances — Page 108
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | Coloplast Corp. Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242430 — Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) | Soul Mobility Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230915 — AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | Vyaire Medical, Inc. Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242420 — pNOVUS 21 Microcatheter | Phenox, Ltd. Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242502 — Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada Supermax Medical Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241981 — Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240771 — PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242018 — UbiqVue 2A Multi-parameter System (UX2550) | Lifesignals, Inc. Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241575 — Straumann® Anatomic Healing Abutments XC (AHA) | Straumann USA, LLC Mon Nov 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243233 — esolution® Esophageal Retractor | S4 Medical Corp. Sat Nov 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241342 — Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240417 — ProFound Detection (V4.0) | Icad, Inc. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242231 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243231 — Trigon PEEK HA Wedges | Nvision Biomedical Technologies Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240510 — Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242286 — Superflow Prime Treatment System (ASP-1M) | Guangzhou Aimira Innovation Technology Co, Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241099 — Plasonic (Plasonic) | Hironic Co., Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243004 — Xpine Spinal Fixation System | Jeil Medical Corporation Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241802 — Device 300397 Putty | Geistlich Pharma AG Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | STERIS Corporation Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240794 — Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242382 — décoLITE LED Device | iSMART Developments, Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242756 — Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) | Pulnovo Medical (Wuxi) Co., Ltd. Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241364 — Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB Fri Nov 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242734 — ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240415 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093) | Rebotix Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241346 — IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240429 — Trilogy Tissue Marker | Inrad, Inc. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242373 — Mako Shoulder Application (1.0) | Mako Surgical Corp. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212425 — MicroTrend System | Exostat Medical, Inc. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241719 — NeuroICH | Neurocareai, Inc. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241468 — Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242379 — LL Implant System | Ossvis Co., Ltd. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240712 — icobrain aria | Icometrix NV Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242361 — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Stryker Spine Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242702 — VioSeal | Spident Co., Ltd. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242595 — Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) | Shenzhen Greatro Electronic Technology Co., Ltd. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240831 — MultiCut Solo | Asclepion Laser Technologies GmbH Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242719 — ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242039 — Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co., Ltd. Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240997 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242803 — Compound W Skin Tag Remover | Medtech Products, Inc. Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243222 — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Biofire Diagnostics, LLC (Biomerieux) Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240450 — Citrepore | Acuitive Technologies, Inc. Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |