Sep 16, 2026
K261758
Embrace Vision Neonatal MRI System
Aspect Imaging, Ltd.
- LNH
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 16, 2026
K261712
Ceribell EEG Analysis Software
Ceribell, Inc.
- OLT
- Class II
Sep 16, 2026
K261623
EchoPAC Software Only / EchoPAC Plug-in (v211)
GE Medical Systems Ultrasound and Primary Care Diagnostics
- QIH
- Class II
Sep 16, 2026
K261467
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)
Gt Metabolic Solutions, Inc.
- SAH
- Class II
Sep 16, 2026
K261400
Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large
Ambu A/S
- FDS
- Class II
Sep 16, 2026
K261370
LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
Guangdong Newdermo Biotech Co., Ltd.
- NFO
- Class II
Sep 16, 2026
K261283
APERTO Lucent MRI System
Fujifilm Corporation
- LNH
- Class II
Sep 16, 2026
K260906
a2z-Abdo-Triage
A2z Radiology Ai, Inc.
- QAS
- Class II
Sep 16, 2026
K260309
Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Ambu A/S
- EOQ
- Class II
Sep 16, 2026
K260226
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
Amptron Medical, Inc.
- BZK
- Class II
Sep 16, 2026
K260220
Route 92 Medical Full Length 046 Access System
Route 92 Medical, Inc.
- QJP
- Class II
Sep 16, 2026
K254212
NC PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd.
- LIT
- Class II
Sep 16, 2026
K254181
Aristotle 65 Macrowire
Scientia Vascular
- MOF
- Class II
Sep 16, 2026
K254152
Dia-X Sil Light Body
DiaDent Group International
- ELW
- Class II
Sep 16, 2026
K254142
Dia-X Sil Heavy Body
DiaDent Group International
- ELW
- Class II
Sep 15, 2026
K262963
TMC Implant Fixation System
Treace Medical Concepts, Inc.
- HRS
- Class II
Sep 15, 2026
K262057
GMK Extension
Medacta International SA
- JWH
- Class II
Sep 15, 2026
K261861
SPINEsim v1.0
Mdsim S.A.
- LLZ
- Class II
Sep 15, 2026
K261677
Artificial Intelligence Renal Assessment (AIRA) Version 1
Aramis Global AI Consultancies, LLC
- QIH
- Class II
Sep 15, 2026
K261447
CVAC® Aspiration System
Calyxo, Inc.
- FGB
- Class II
Sep 15, 2026
K261070
LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Covidien, LLC
- GEI
- Class II
Sep 15, 2026
K260446
Tontarra Punches and Rongeurs
Tontarra Medizintechnik GmbH
- HAE
- Class II
Sep 15, 2026
K260145
YJ-K1K2 Wheelchair (YJ-013F)
Zhenjiang Assure Medical Equipment Co., Ltd.
- IOR
- Class I
Sep 15, 2026
K260144
Reclining wheelchair (YJ-013L)
Zhenjiang Assure Medical Equipment Co., Ltd.
- IOR
- Class I
Sep 15, 2026
K260141
Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
Zhenjiang Assure Medical Equipment Co., Ltd.
- IOR
- Class I