Oct 14, 2026
K260676
Radius VSM and Accessories
Masimo Corporation
- MHX
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 14, 2026
K260581
KARL STORZ Flexible Video Neuro-Endoscope
Karl Storz SE & CO. KG
- GWG
- Class II
Oct 14, 2026
K260264
Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)
Shanghai Medi Astro Technology Co., Ltd.
- ETA
- Class II
Oct 13, 2026
K263257
Electrically Powered Wheelchair (YC-01)
Yurob Rehabilitation Medical Co., Ltd.
- ITI
- Class II
Oct 13, 2026
K262652
Electric Wheelchair (CN501)
Zhejiang Shimo Technology Co., Ltd.
- ITI
- Class II
Oct 13, 2026
K262433
OrthoFit Aligner (OrthoFit Aligner A2)
Spident Co., Ltd.
- DYH
- Class II
Oct 13, 2026
K261572
Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
Keyue (Hangzhou) Medical Information Technology Co., Ltd.
- GEX
- Class II
Oct 13, 2026
K261321
Yomi S Robotic System
Neocis, Inc.
- QRY
- Class II
Oct 13, 2026
K252288
TECAR Therapy Device (TC2000, TC2001)
Shenzhen Dongdixin Technology Co., Ltd.
- PBX
- Class II
Oct 11, 2026
K253717
Helo™ Return
Endovascular Engineering, Inc.
- SHJ
- Class II
Oct 9, 2026
K263154
CarboClear® Cervical Navigated Instruments
CarboFix Orhtopedics , Ltd.
- OLO
- Class II
Oct 9, 2026
K262902
ECHELON Synergy
Fujifilm Corporation
- LNH
- Class II
Oct 9, 2026
K262834
Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)
Shenzhen Jianchao Intelligent Technology Co., Ltd.
- OAP
- Class II
Oct 9, 2026
K262352
IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
Shenzhen Jianchao Intelligent Technology Co., Ltd.
- OHT
- Class II
Oct 9, 2026
K262301
Rapid ICH (v4.0)
Ischemaview, Inc.
- QAS
- Class II
Oct 9, 2026
K262090
Fertilis microICSI Device
Fertilis Pty, Ltd.
- MQK
- Class II
Oct 9, 2026
K262068
Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)
CathRx, Ltd.
- DRF
- Class II
Oct 9, 2026
K261649
Excelsior Reach Microcatheter
Stryker Neurovascular
- QJP
- Class II
Oct 9, 2026
K261521
Sleep Analysis Module
Neurotronics, LLC
- OLZ
- Class II
Oct 9, 2026
K261234
The D-Tip Denudation Pipette
Allwin Medical Devices, Inc.
- MQH
- Class II
Oct 9, 2026
K260913
CMF Titanium Splints
Materialise NV
- DZJ
- Class II
Oct 9, 2026
K260687
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.
Vivachek Biotech (Hangzhou) Co., Ltd.
- NBW
- Class II
Oct 9, 2026
K260156
TruVision Single-Use 1.9mm Arthroscopy System
Nexus CMF, LLC
- HRX
- Class II
Oct 9, 2026
K260096
Wishbone HAE
Wishbone SA
- NPM
- Class II
Oct 9, 2026
K260080
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
Medical Components, Inc.
- LJS
- Class II