Sep 19, 2026
K261859
Electric Scooter (FDB08, FDB08A, FDB12)
Anhui JBH Medical Apparatus Co., Ltd.
- INI
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 19, 2026
K252723
Dynamis Pro Family
Fotona D.O.O.
- GEX
- Class II
Sep 19, 2026
K241973
SmartIPL_NI System
Lumenis Be, Ltd.
- GEX
- Class II
Sep 18, 2026
K262817
CrossFAST Integrated Microcatheter Advanced Delivery System
Vantis Vascular, Inc.
- DQY
- Class II
Sep 18, 2026
K262637
SLIT LAMP SL-D4 (Type: LED)
Topcon Corporation
- HJO
- Class II
Sep 18, 2026
K262599
Biolinq Shine Autonomous Time-in-Range Microsensor
Biolinq Incorporated
- SFU
- Class II
Sep 18, 2026
K262532
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
ICU Medical
- LGZ
- Class II
Sep 18, 2026
K262524
Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
ONE BEAUTY Technology Co., Ltd.
- OHT
- Class II
Sep 18, 2026
K262262
Pathfinder Endoscope Overtube
Neptune Medical, Inc.
- FED
- Class II
Sep 18, 2026
K262098
EnHAnce PEEK Bunion System
Nvision Biomedical Technologies
- HRS
- Class II
Sep 18, 2026
K261855
Elucid PlaqueIQ
Elucid Bioimaging, Inc.
- LLZ
- Class II
Sep 18, 2026
K261736
MAGENTA BLAST
Future Fertility, Inc.
- PBH
- Class II
Sep 18, 2026
K261229
SCENARIA View Phase 6.0
Fujifilm Corporation
- JAK
- Class II
Sep 18, 2026
K261102
UNIDRIVE Select System
Karl Storz SE & CO. KG
- HIH
- Class II
Sep 18, 2026
K261047
Dental Diode Laser Device (Laser-Pen)
Guilin Kevin Peter Technology Co., Ltd.
- GEX
- Class II
Sep 18, 2026
K260008
Deterioration Index Version 2
Epic Systems Corporation
- QNL
- Class II
Sep 18, 2026
K254238
MINT MONO Sutures
Hans Biomed Corporation
- NEW
- Class II
Sep 18, 2026
K254179
Drainage Catheter
Canyon Medical, Inc.
- FGE
- Class II
Sep 18, 2026
K254171
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
Shenzhen Mericonn Technology Co., Ltd.
- CAF
- Class II
Sep 18, 2026
K254160
VacHeal Negative Pressure Wound Therapy System
VacHeal, LLC
- OKO
- Class II
Sep 18, 2026
K254095
25G Huber Needle
Martech Medical Products
- PTI
- Class II
Sep 18, 2026
K253419
Triever Duo Catheter
Inari Medical, Inc.
- QEW
- Class II
Sep 18, 2026
K253146
Hyperdrive 35 Guidewire
Rapid-Medical , Ltd.
- DQX
- Class II
Sep 17, 2026
K262913
Protégé™ EverFlex™ Self-expanding Peripheral Stent System
Medtronic, Inc.
- FGE
- Class II
Sep 17, 2026
K262495
Miru 1day UpSide (midafilcon A)
Menicon Co, Ltd.
- LPL
- Class II