Sep 30, 2026
K262621
Rapid Barostat Bag (RBB) Pump and Catheter System
Mui Scientific, Inc.
- FFX
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 30, 2026
K262257
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
Brainlab SE
- OLO
- Class II
Sep 30, 2026
K262038
danumed StomaMeter
Danumed Medizintechnik GmbH
- KNT
- Class II
Sep 30, 2026
K261975
Braun Aura 7 (6041)
CyDen Limited
- OHT
- Class II
Sep 30, 2026
K261663
EzSensor HD
Qpix Solutions, Inc.
- MUH
- Class II
Sep 30, 2026
K261469
Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).
Barco N.V.
- DXJ
- Class II
Sep 30, 2026
K261327
Elos Accurate Hybrid Base
Elos Medtech Pinol A/S
- NHA
- Class II
Sep 30, 2026
K254302
ECG Analysis Software (AiTiALVSD)
Medical AI Co., Ltd.
- QYE
- Class II
Sep 29, 2026
K263073
Fast Absorbing PGLA
Riverpoint Medical, LLC
- GAM
- Class II
Sep 29, 2026
K263048
Syngo Carbon Space (VA4)
Siemens Healthineers AG
- LLZ
- Class II
Sep 29, 2026
K262726
NeckTune™ SA Cervical Cage
Medyssey Co., Ltd.
- OVE
- Class II
Sep 29, 2026
K262721
Spinalogic Bone Growth Stimulator
Djo, LLC
- LOF
- Class II
Sep 29, 2026
K262553
MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)
Zhejiang Kailang Technology Co., Ltd.
- INI
- Class II
Sep 29, 2026
K262241
Electric Wheelchair (0080)
Xuzhou Heabens Medical Technology Co., Ltd.
- ITI
- Class II
Sep 29, 2026
K262213
Power Mobility Scooter (MA03)
Nanjing Mijo Technology Co., Ltd.
- INI
- Class II
Sep 29, 2026
K262015
Elucid FFR-IQ (B.1)
Elucid Bioimaging, Inc.
- PJA
- Class II
Sep 29, 2026
K261225
CAS-One IR
Cascination AG
- JAK
- Class II
Sep 29, 2026
K260250
QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
QT Medical, Inc.
- DPS
- Class II
Sep 29, 2026
K260031
THERMEO® I MSI
Pro3Dure Medical GmbH
- MQC
- Unclassified
Sep 29, 2026
DEN260007
SmartRead(TM) Medical Device Identifier (4100)
BridgeSource Medical Corporation
- SJJ
- Class II
Sep 28, 2026
K262649
Alians Forearm
Newclip Technics
- HRS
- Class II
Sep 28, 2026
K262052
Tri Stage Venous Cannulae
Sorin Group Italia S.R.L.
- DWF
- Class II
Sep 28, 2026
K261543
Phasix ST Parastomal Hernia Mesh
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
- OWT
- Class II
Sep 28, 2026
K260619
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
Biomérieux, Inc.
- LON
- Class II
Sep 28, 2026
K260474
Liora Monofilament Scaffold
TELA Bio, Inc.
- FTL
- Class II