Aug 21, 2026
K260584
BoneMRI
Mriguidance B.V.
- QIH
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Aug 21, 2026
K253817
IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
Immunodiagnostics Systems Limited
- LLL
- Class II
Aug 21, 2026
K253728
EVOLUTION® AM BIOFOAM® Tibial System
Microport Orthopedics, Inc.
- MBH
- Class II
Aug 21, 2026
K253726
uAngio AVIVA CX
Shanghai United Imaging Healthcare Co., Ltd.
- OWB
- Class II
Aug 21, 2026
K253699
Tempus ECG-PH
Tempus AI, Inc.
- SAT
- Class II
Aug 21, 2026
K253692
AVVIGO™+ Multi-Modality Guidance System
Boston Scientific
- DQK
- Class II
Aug 21, 2026
DEN250067
ReneuRx™ (Neural Ice)
Brixton Biosciences
- SJA
- Class II
Aug 21, 2026
DEN250026
Avulux
Matap Ii, LLC
- QEO
- Class I
Aug 20, 2026
K262515
Kneu Platform (V2)
Kneu Health Digital , Ltd.
- GYD
- Class II
Aug 20, 2026
K262506
Remex Spine Surgery Navigation - Universal Instruments
Remex Medical Corp.
- OLO
- Class II
Aug 20, 2026
K262113
HardyDisk AST Tebipenem 10µg (TBP10)
Hardy Diagnostics
- JTN
- Class II
Aug 20, 2026
K261298
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
Guangdong Youmeng Electrical Technology Co., Ltd.
- HGX
- Class II
Aug 20, 2026
K261049
SCALA® TL
Spineart SA
- MAX
- Class II
Aug 20, 2026
K260817
MIRA Surgical System
Virtual Incision
- SAB
- Class II
Aug 20, 2026
K260579
Infinity® Acute Care System (IACS) – VG8.1
Draeger Medical Systems, Inc.
- MHX
- Class II
Aug 20, 2026
K260242
CPETWise Platform
Medibyt , Ltd.
- BTY
- Class II
Aug 20, 2026
K253807
Valence InVent Xtend™ (CVG-4101-VXA)
Convergence Medical Sciences , Ltd.
- MOD
- Class II
Aug 20, 2026
DEN250043
Qoramatic Automated Stool Management
Cm Technologies, Inc.
- SJB
- Class II
Aug 19, 2026
K262622
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
- LNH
- Class II
Aug 19, 2026
K262537
Versalock Sterile Plating System
GM Dos Reis Industria e Comercio Ltda.
- HRS
- Class II
Aug 19, 2026
K262070
Diode Laser Therapy Systems (DL612A)
Hebei Zollvan Medical Technology Co., Ltd.
- GEX
- Class II
Aug 19, 2026
K261964
ECHOLASER X4
Elesta S.P.A
- GEX
- Class II
Aug 19, 2026
K261686
Elecsys Phospho-Tau (217P) Plasma
Roche Diagnostics
- SET
- Class II
Aug 19, 2026
K261413
EXTRON 3;EXTRON 6
DRTECH Corporation
- OWB
- Class II
Aug 19, 2026
K261083
Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
CooperSurgical, Inc.
- MQG
- Class II