Oct 30, 2026
K263860
Shining3D Clear Aligner System
Hangzhou SHINING3D Dental Technology Co., Ltd.
- NXC
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
95 records
Oct 30, 2026
K263592
da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc.
- NAY
- Class II
Oct 30, 2026
K263587
Arctic Sun™ Neonatal ArcticGel™ Pad
Medivance, Inc.
- DWJ
- Class II
Oct 30, 2026
K263232
eplex RP3 Control M530; eplex RP3 Negative
Maine Molecular Quality Controls, Inc.
- PMN
- Class II
Oct 30, 2026
K263109
EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Ever Fortune.Ai, Co., Ltd.
- QAS
- Class II
Oct 30, 2026
K263076
AngioVac F1885
AngioDynamics, Inc.
- DWF
- Class II
Oct 30, 2026
K263075
Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
Strauss Surgical USA
- FAJ
- Class II
Oct 30, 2026
K263063
B`orze Inc Laser Family (Sorren/Adonis)
Borze, Inc.
- GEX
- Class II
Oct 30, 2026
K262971
Xpert® Hemorrhagic Fever Panel
Cepheid
- QVR
- Class II
Oct 30, 2026
K262938
cobas eplex respiratory pathogen panel 3
GenMark Diagnostics, Inc.
- QOF
- Class II
Oct 30, 2026
K262816
EXG PulseLinQ Cables (EXGPL)
Cb Innovations, LLC
- DSA
- Class II
Oct 30, 2026
K262685
Zirconia Collective 4Y Dental Zirconia Blank
Zirconia Collective, Inc.
- EIH
- Class II
Oct 30, 2026
K262470
Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)
Changsha Anxiang Medical Technology Co., Ltd.
- NGX
- Class II
Oct 30, 2026
K262066
Pleiades Device
My123Baby Medical Limited Dba Boost Fertility
- MQK
- Class II
Oct 30, 2026
K261886
VIVO (9002)
Catheter Precision, Inc.
- DQK
- Class II
Oct 30, 2026
K261072
DS Core Detect
Dentsply Sirona, Inc.
- MYN
- Class II
Oct 30, 2026
K260738
Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
Changsha Sinocare, Inc.
- NBW
- Class II
Oct 30, 2026
K260648
PolySense
Itamar Medical , Ltd.
- GWL
- Class II
Oct 30, 2026
K260575
AutoGel Pad (400-046,400-005)
Top-Rank Health Care Co., Ltd.
- MUI
- Class II
Oct 30, 2026
K260360
AesyBite Active
Aesyra SA
- HCC
- Class II
Oct 30, 2026
K260354
Foster Plus-22L (SNK/CE-F22)
Zhejiang Fomos Medical Technology Co., Ltd.
- FLE
- Class II
Oct 30, 2026
K260306
RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
Smith & Nephew Medical, Ltd.
- OMP
- Class II
Oct 30, 2026
K260058
Kerecis Express (50250)
Kerecis Limited
- KGN
- Unclassified
Oct 30, 2026
K253095
ULSPIRA TS™ Nitric Oxide Therapy System
Airgas Therapeutics, LLC
- MRN
- Class II
Oct 30, 2026
DEN250054
Virtuoso Endoscopy System
Virtuoso Surgical, Inc.