510(k) Clearances — Page 183
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K223811 — Lung-CAD | Imagen Technologies, Inc. Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232158 — GenX-CR | Genoray Co., Ltd. Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231112 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230598 — Stone Extraction Baskets | Jiangsu Vedkang Medical Science and Technology Co., Ltd. Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213767 — Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232459 — Velacur | Sonic Incytes Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231317 — TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231766 — Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231892 — Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231748 — Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231011 — Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222938 — Ablation-fit | R.A.W. S.R.L Tue Sep 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230881 — Change Healthcare Cardiology Hemodynamics | Change Healthcare Israel , Ltd. Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223755 — i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231283 — SiteRite 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232192 — Venus Versa PRO System | Venus Concept, Inc. Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230517 — Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) | Jarmon Medical, LLC (Dba Legends Orthopedics) Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231504 — TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System | Vilex, LLC Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231746 — VERIFY Spore Test Strip for S40 Sterilant Concentrate | STERIS Corporation Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230362 — Planar LED mate | Shenzhen Leaflife Technology Co., Ltd. Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | MiRus, LLC Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232002 — Vantage® Total Ankle System | Exactech, Inc. Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG Sat Sep 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231723 — Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231727 — Sterile Auto-Disable Syringes with/without Needle for Single Use | Wepon Medical Technology Co., Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232400 — VariSeed (v10) | Varian Medical Systems Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231643 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Syntex Healthcare Products Co., Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230372 — VitreJect Syringe | Ocuject, LLC Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232413 — Fusion Robotic Navigation System | Alphatec Spine, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232686 — CorVista® System | Corvista Health, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232386 — ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 | ABBOTT MEDICAL Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222921 — Minuteful-kidney test | Healthy.Io, Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223848 — Intrisound Tuned Lumen® 155 Hearing Aids | Tuned , Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230661 — Zeta Cranial Navigation System | Zeta Surgical Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223621 — DeepXray | Alpha Intelligence Manifolds, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | Conformis, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230535 — KARL STORZ Urological Laser Accessories | Karl Storz SE & CO. KG Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231729 — Sterile syringes for single use with/without needle | Wepon Medical Technology Co., Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231284 — OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231720 — Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230890 — ISE Electrodes | Randox Laboratories, Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231335 — Cleerly ISCHEMIA | Cleerly, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232414 — Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Total Joint Othopedics, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231141 — STarFix Designer Software C0265 | FHC, Inc. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231146 — AliTight | Alic Iotech, LLC Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232457 — Q-FIX ULTRA All-Suture Anchor | Smith & Nephew Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |