Oct 21, 2026
K263422
Mint ACE Pump
Beta Bionics, Inc.
- QFG
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 21, 2026
K263352
TeKBrace Knotless Anchor
TheraMicro
- MBI
- Class II
Oct 21, 2026
K263319
ACHM30 AtriClip FLEX-Mini LAA Exclusion System
AtriCure, Inc.
- PZX
- Class II
Oct 21, 2026
K262980
INNI-CERA (BCM-W500, BCM-W1000)
DentMedi Co., Ltd.
- EIH
- Class II
Oct 21, 2026
K262646
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System
Alphatec Spine, Inc.
- MAX
- Class II
Oct 21, 2026
K262573
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control
Maine Molecular Quality Controls, Inc.
- PMN
- Class II
Oct 21, 2026
K262136
BIOFIRE SPOTFIRE Vaginitis (VG) Panel
Biofire Diagnostics, LLC
- PQA
- Class II
Oct 21, 2026
K262021
Toro 71 Aspiration Catheter; Toro Aspiration Tubing
Toro Neurovascular, Inc.
- NRY
- Class II
Oct 21, 2026
K261788
Eden PACS
Higia., Inc. d/b/a Eden
- LLZ
- Class II
Oct 21, 2026
K261531
PV-iCurve Pro
Perception Vision Medical Technology Co., Ltd.
- LLZ
- Class II
Oct 21, 2026
K261347
DASH Flu A/B Test
Nuclein, LLC
- OCC
- Class II
Oct 21, 2026
K261252
Versius Surgical System (Versius Plus)
Cmr Surgical Limited
- SCV
- Class II
Oct 21, 2026
K260857
Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set
Sol-Millennium Medical, Inc.
- JKA
- Class II
Oct 21, 2026
K252736
Hemotag Analysis Software (HAS)
Aventusoft, LLC
- DQD
- Class II
Oct 20, 2026
K262937
PDR Airway Device
Park Dental Research Corp.
- LRK
- Class II
Oct 20, 2026
K262664
Rongjian Self-adhesive Electrode
Bozhou Rongjian Medical Appliance Co., Ltd.
- GXY
- Class II
Oct 20, 2026
K262628
Picosecond Laser treatment system (Z180)
Sanhe PERFECTLASER Technology Co., Ltd.
- GEX
- Class II
Oct 20, 2026
K262597
Access BNP II
Beckman Coulter, Inc.
- NBC
- Class II
Oct 20, 2026
K262421
Daybreak Impression Material
Sleepcare, LLC
- SHI
- Class II
Oct 20, 2026
K262386
SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000)
Stryker Instruments
- GEI
- Class II
Oct 20, 2026
K262093
Accuro XV
Rivanna Medical, Inc.
- IYO
- Class II
Oct 20, 2026
K262062
CINA-Aneurysm
Avicenna.Ai
- QBS
- Class II
Oct 20, 2026
K260708
Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)
Vein 360
- FGB
- Class II
Oct 20, 2026
K260215
BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)
Bd Biosciences
- PWD
- Class II
Oct 20, 2026
DEN260027
Elecsys HBsAg II quant II RxDx
Roche Diagnostics