Oct 29, 2026
K263648
Vitrea Advanced Visualization, Version 7.16
Canon Medical Informatics, Inc.
- LLZ
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 29, 2026
K263628
ELEOS™ Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)
Onkos Surgical, Inc.
- QZZ
- Class II
Oct 29, 2026
K263602
Arthrex Plates, Screws and Pins, and Washers
Arthrex, Inc.
- HRS
- Class II
Oct 29, 2026
K263598
VasQ
Laminate Medical Technologies
- QVQ
- Class II
Oct 29, 2026
K263596
DLP™ Coronary Ostial Cannulae
Medtronic, Inc.
- DWF
- Class II
Oct 29, 2026
K263582
KeriFlex® MCP and PIP Finger Joint Prostheses
Keri Medical SA
- KYJ
- Class II
Oct 29, 2026
K263530
V-Pro maX 2 Low Temperature Sterilization System
STERIS
- MLR
- Class II
Oct 29, 2026
K263459
SWICS™
Bloom Surgical, Inc.
- GCJ
- Class II
Oct 29, 2026
K263065
MicroPort Total Knee System
Suzhou Microport Orthorecon Co., Ltd.
- JWH
- Class II
Oct 29, 2026
K262960
Cerclage Cabling System
Pioneer Surgical Technology, Inc. dba EXALTA Group
- JDQ
- Class II
Oct 29, 2026
K262839
Cleerly ISCHEMIA
Cleerly, Inc.
- QXZ
- Class II
Oct 29, 2026
K262756
Zirconia Dental Ceramics and Staining Solution
Fanen New Materials Technology (Suzhou) Co., Ltd.
- EIH
- Class II
Oct 29, 2026
K262731
Virata Spinal Fixation System
SeaSpine Orthopedics Corporation
- NKB
- Class II
Oct 29, 2026
K262574
Convoy Expandable Corpectomy System
SeaSpine Orthopedics Corporation
- MQP
- Class II
Oct 29, 2026
K262572
Symmetrix™ PX Spinal System
Medtronic Sofamor Danek USA, Inc.
- MAX
- Class II
Oct 29, 2026
K262570
TZ Medical Birthing Balloon Kit
TZ Medical
- PFJ
- Class II
Oct 29, 2026
K262437
Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
Zhejiang Geyi Medical Instrument Co., Ltd.
- FGB
- Class II
Oct 29, 2026
K262415
OSSIX Plus
Datum Dental, Ltd.
- NPL
- Class II
Oct 29, 2026
K262318
Minder® System
Epi-Minder Pty, Ltd.
- SEM
- Class II
Oct 29, 2026
K262125
Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
Nenesupply Co., Ltd.
- HGX
- Class II
Oct 29, 2026
K260975
Libertas Acetabular Liners (Acetabular Liner)
Maxx Orthopedics, Inc.
- JDI
- Class II
Oct 29, 2026
K260427
Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)
Lumicare Medtech Co., Ltd.
- SCS
- Class II
Oct 29, 2026
K260356
EndoColibri
Koehrer Medical Engineering GmbH
- NYL
- Class I
Oct 29, 2026
K260337
SEEG-Tx® System (STX-SYS-001)
Dixi Medical
- GXD
- Class II
Oct 29, 2026
K253508
Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
Vietglove Corporation
- LZA
- Class I