Oct 28, 2026
K263583
Tornier Humeral Reconstruction System (HRS) Tuberosity Body
Tornier, Inc.
- KWS
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 28, 2026
K263512
Luja female
Coloplast Corp.
- EZD
- Class II
Oct 28, 2026
K263313
Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092)
Shenzhen Rainbow Technology Co., Ltd.
- OAP
- Class II
Oct 28, 2026
K263005
Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)
Anhui Longway Medical Technology Co., Ltd.
- ITI
- Class II
Oct 28, 2026
K262343
Dynavisc
Fziomed, Inc.
- OWW
- Class II
Oct 28, 2026
K262242
Profoject™ Safe Push Button Blood Collection Sets
CMT Health PTE., Ltd.
- JKA
- Class II
Oct 28, 2026
K261676
uPMR Zenith
Shanghai United Imaging Healthcare Co., Ltd.
- OUO
- Class II
Oct 28, 2026
K261648
Evident Vascular™ Guidance System
Evident Vascular, Inc.
- IYO
- Class II
Oct 28, 2026
K261636
Microwave Ablation Antennas
Canyon Medical, Inc.
- NEY
- Class II
Oct 28, 2026
K261630
GI Windows Flexagon Plus OTOLoc System
GI Windows Surgical
- SAH
- Class II
Oct 28, 2026
K261628
LymphaTech Mobile 3D Measuring Tool
Lymphatech, Inc.
- OBH
- Class II
Oct 28, 2026
K260822
VERIFY RESI-TEST SWAB Protein Detection Indicator
Steris
- SDC
- Class II
Oct 28, 2026
K260670
YUWELL® Electronic Blood Pressure Monitor
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- DXN
- Class II
Oct 28, 2026
K260311
Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV toric (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV multifocal (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
St. shine Optical Co., Ltd.
- LPL
- Class II
Oct 28, 2026
K260310
HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
O&M Halyard, Inc.
- QSO
- Class II
Oct 27, 2026
K263477
Arthrex FiberButton
Arthrex, Inc.
- MBI
- Class II
Oct 27, 2026
K263461
Tendon Anchor
Smith & Nephew, Inc.
- GDW
- Class II
Oct 27, 2026
K262775
AquaVance Clear Fluoride Treatment
The Belport Company Inc., DBA Gingi-Pak
- LBH
- Class II
Oct 27, 2026
K262531
OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power Driver
Teleflex Medical, LLC
- KNW
- Class II
Oct 27, 2026
K262349
Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)
Risu Medical Technology Co., Ltd.
- GEX
- Class II
Oct 27, 2026
K262229
DORO® Headrest System for AVA
Black Forest Medical GmbH
- HBL
- Class II
Oct 27, 2026
K261740
Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)
Robotrak Technologies Co., Ltd.
- MYC
- Class II
Oct 27, 2026
K261714
FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
Transonic Systems, Inc.
- DPW
- Class II
Oct 27, 2026
K261512
OsteoSight Spine (v1)
Naitive Technologies, Ltd.
- SAO
- Class II
Oct 27, 2026
K261379
BD Veritor System for SARS-CoV-2
BD Diagnostic Solutions / Becton, Dickinson & Company
- QVF
- Class II