Oct 8, 2026
K263680
One Coat Bond; One Coat Bond SL
Dent4You AG
- KLE
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 8, 2026
K263150
V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
- IYN
- Class II
Oct 8, 2026
K262346
CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)
Wuhan Phomed Technology Co., Ltd.
- GEX
- Class II
Oct 8, 2026
K262244
Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)
Stryker Instruments
- LFL
- Unclassified
Oct 8, 2026
K261805
NEXT-Cue
Neuroxt, Inc.
- QWT
- Class II
Oct 8, 2026
K261617
Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- IYN
- Class II
Oct 8, 2026
K260426
MeCare Alpha (MCA2019)
IVT Medical, Ltd.
- OMP
- Class II
Oct 7, 2026
K263159
prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments
Centinel Spine, LLC
- QLQ
- Class II
Oct 7, 2026
K262822
Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)
Zhongshan GL Electronics Co. , Ltd.
- BTA
- Class II
Oct 7, 2026
K262378
Dr.AlignNavi
InnoDtech, Inc.
- PNN
- Class II
Oct 7, 2026
K262368
B. anthracis Real-time PCR Assay
Centers for Disease Control and Prevention
- NHT
- Class II
Oct 7, 2026
K262134
NeuroDR
Deep Reasoning Ai, Inc.
- QIH
- Class II
Oct 7, 2026
K261733
Ligence Heart
UAB Ligence
- QIH
- Class II
Oct 7, 2026
K261692
Diode Laser Hair Removal Machine (QDTM-03)
Beijing Nubway S&T Co., Ltd.
- GEX
- Class II
Oct 7, 2026
K261120
APEX 3D S Diamond Tibia
Paragon 28, Inc.
- HSN
- Class II
Oct 7, 2026
K260092
Vista AI Scan
Vista AI, Inc.
- LNH
- Class II
Oct 7, 2026
K260075
eClinics
Ceiba Healthcare US, Inc.
- MSX
- Class II
Oct 6, 2026
K262798
LOBO Vascular Occlusion System
Okami Medical, Inc.
- KRD
- Class II
Oct 6, 2026
K262516
TSK OptiXion
Tsk Laboratory, Japan
- QYM
- Class II
Oct 6, 2026
K262043
MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike
Bayer Medical Care, Inc.
- DXT
- Class II
Oct 6, 2026
K261938
APRO 88 Catheter
Alembic, LLC
- QJP
- Class II
Oct 6, 2026
K261887
Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)
NormaTec Industries, LP
- IRP
- Class II
Oct 6, 2026
K261200
Power Wheelchair (D60)
Anhui JBH Medical Apparatus Co., Ltd.
- ITI
- Class II
Oct 6, 2026
K261141
OpenFlo Urinary Catheter
Urolution Medical, Inc.
- EZL
- Class II
Oct 6, 2026
K261079
Power Wheelchair (DC12)
Anhui JBH Medical Apparatus Co., Ltd.
- ITI
- Class II