Oct 6, 2026
K260136
Forza
True Function Laboratory, Inc.
- LRK
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 5, 2026
K262813
InkSpace Imaging Small Body Array (SBA12PH15x)
Inkspace Imaging, Inc.
- MOS
- Class II
Oct 5, 2026
K262812
Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
Sichuan Qianli-Beoka Medical Technology, Inc.
- IRP
- Class II
Oct 5, 2026
K262285
UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)
Shijiazhuang Recovery Star Medical Device Co., Ltd.
- FTC
- Class II
Oct 5, 2026
K261939
Glucommander
Glytec, LLC
- NDC
- Class II
Oct 5, 2026
K261655
RT Elements (4.6)
Brainlab SE
- MUJ
- Class II
Oct 5, 2026
K260523
QGuideCT (1.0)
Medis Medical Imaging Systems BV
- QIH
- Class II
Oct 5, 2026
K260005
MyoVista wavECG (DG-200-B15-003)
HeartSciences, Inc.
- DPS
- Class II
Oct 2, 2026
K263120
Xpert Xpress CoV-2/Flu plus
Cepheid®
- QOF
- Class II
Oct 2, 2026
K263116
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
OsteoCentric Technologies
- HWC
- Class II
Oct 2, 2026
K263113
ZSAlign Cervical Interbody System
ZSFab, Inc.
- OVE
- Class II
Oct 2, 2026
K263086
AltiVate Reverse® Glenosphere with RAVN™ Technology
Encore Medical L.P.
- PHX
- Class II
Oct 2, 2026
K263083
Response Ortho Smart Fixator - Hexapod System
Response Ortho Solutions, LLC
- KTT
- Class II
Oct 2, 2026
K262985
Medical Monitor (32MD08WC)
Lg Electronics.Inc
- PGY
- Class II
Oct 2, 2026
K262412
Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)
Barco NV
- PGY
- Class II
Oct 2, 2026
K261943
REMEX-T(K)100C
Remedi, Inc.
- IZL
- Class II
Oct 2, 2026
K261933
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
- IYN
- Class II
Oct 2, 2026
K261791
MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor
Steris
- FEB
- Class II
Oct 2, 2026
K261783
Plenity-V (MC0979 / GS110)
Gelesis SRL
- QFQ
- Class II
Oct 2, 2026
K261741
Hemostatic Clip
Anrei Medical (Hz) Co., Ltd.
- PKL
- Class II
Oct 2, 2026
K261611
TDM Large Bone Plate and Screw System
Tdm Co., Ltd.
- HRS
- Class II
Oct 2, 2026
K261607
Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System
Spinal Simplicity, LLC
- PEK
- Class II
Oct 2, 2026
K261217
AnyPlus II Spinal Fixation System
GS Medical Co., Ltd.
- NKB
- Class II
Oct 2, 2026
K261042
Lung Guidance
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- QJU
- Class II
Oct 2, 2026
K260689
CVS Advanced PLUS Blood Glucose Monitoring System
I-Sens, Inc.
- NBW
- Class II