Aug 25, 2026
K254304
iNOS intraoral biosensor
Achaemenid, LLC
- PLC
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Aug 25, 2026
K253879
MONOFIX PDO
Samyang Holdings Corporation
- NEW
- Class II
Aug 25, 2026
K252535
Inno-Switch™ Laparoscopic Instruments
Taiwan Surgical Corporation
- GEI
- Class II
Aug 25, 2026
K252184
SOL-M Luer Lock Syringe with Exchangeable Needle Tray
Sol-Millennium Medical, Inc.
- FMF
- Class II
Aug 25, 2026
DEN250049
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
Abbott Diabetes Care
- SJD
- Class II
Aug 24, 2026
K261381
TiLink-L™ SI Joint Fusion System
SurGenTec, LLC
- OUR
- Class II
Aug 24, 2026
K260604
BiWaze Clear System
Abmrc, LLC
- NHJ
- Class II
Aug 24, 2026
K260246
SEISMIQ™ Intravascular Lithotripsy System
Bolt Medical, Inc.
- PPN
- Class II
Aug 24, 2026
K260106
OsteoCoil™ GT Active Compression System
Flower Orthopedics Corporation DBA Conventus Flower Orthoped
- HWC
- Class II
Aug 24, 2026
K254286
Guided Bone Regeneration System
DentalMaster(Xiamen)Medical Technology Co., Ltd.
- DZL
- Class II
Aug 24, 2026
K254027
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
Sonoscape Medical Corp.
- IYN
- Class II
Aug 24, 2026
K253515
Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments
Biomet Orthopedics, Inc.
- JDI
- Class II
Aug 23, 2026
K260691
BTL-699
BTL Industries, Inc.
- OBP
- Class II
Aug 22, 2026
K253910
Stitch - Suture Wires and Tapes
GM Dos Reis Industria e Comercio Ltda.
- GAT
- Class II
Aug 21, 2026
K262538
Artix™ MT;Artix™ Thin-Walled Sheath
Inari Medical, Inc.
- QEW
- Class II
Aug 21, 2026
K262127
DS Core CBCT Anatomy
Dentsply Sirona
- QIH
- Class II
Aug 21, 2026
K262089
Disposable Warming Blanket
Hangzhou Tappa Medical Technology Co., Ltd.
- DWJ
- Class II
Aug 21, 2026
K262074
Any-Zircos
Mediclus Co., Ltd.
- EIH
- Class II
Aug 21, 2026
K262005
Affera Integrated Mapping System
Medtronic, Inc.
- DQK
- Class II
Aug 21, 2026
K261882
Pisces-SC Standalone Cervical Interbody System
Osseus Fusions Systems, LLC
- OVE
- Class II
Aug 21, 2026
K261710
AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors
Apyx Medical Corporation
- QPB
- Class II
Aug 21, 2026
K261466
Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
Zeus Scientific
- MOB
- Class II
Aug 21, 2026
K261354
Electric wheelchair (D03)
Foshan Sowell Medical Technology Co., Ltd.
- ITI
- Class II
Aug 21, 2026
K261015
Solo Scope Colonoscope System
Gi View, Ltd.
- FDF
- Class II
Aug 21, 2026
K260643
Cimilre Dual Max
Cimilre Co., Ltd.
- HGX
- Class II