Aug 27, 2026
K260856
Disposable Distal Attachment D-201-13404
Olympus Medical Systems Corporation
- FDS
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Aug 27, 2026
K260824
Gastrointestinal Videoscope Olympus GIF-2T1500
Olympus Medical Systems Corporation
- FDS
- Class II
Aug 27, 2026
K260751
35 Helix Guidewire
Piraeus Medical, Inc.
- MOF
- Class II
Aug 27, 2026
K260711
Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)
Berkeley Advanced Biomaterials
- KGN
- Unclassified
Aug 27, 2026
K260545
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System
Ascensia Diabetes Care
- NBW
- Class II
Aug 27, 2026
K260481
GC85A
Samsung Electronics Co., Ltd.
- KPR
- Class II
Aug 27, 2026
K260401
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
Olympus Medical Systems Corporation
- PSV
- Class II
Aug 27, 2026
K253859
Scarlet Pro (Scarlet Pro)
VIOL Co., Ltd.
- GEI
- Class II
Aug 26, 2026
K262595
VariLift-C Cervical Interbody Fusion System
Wenzel Spine, Inc.
- ODP
- Class II
Aug 26, 2026
K262581
GraftGun Universal Graft Delivery System (GDS®)
SurGenTec, LLC
- FMF
- Class II
Aug 26, 2026
K261394
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
JOYTECH Healthcare Co., Ltd.
- DXN
- Class II
Aug 26, 2026
K261153
LithoVue Elite Digital Flexible Ureteroscope System
Boston Scientific Corporation
- FGB
- Class II
Aug 26, 2026
K261142
Ponto 5 Mini; Ponto 5 Superpower
Oticon Medical AB
- MAH
- Class II
Aug 26, 2026
K260972
OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
Sony Corporation
- GCJ
- Class II
Aug 26, 2026
K260811
Heartvue.Proton
Heartvue.ai, Inc.
- QIH
- Class II
Aug 26, 2026
K260733
MRIA Radiation Therapy Information System (MRIA)
Manteia Technologies Co., Ltd.
- IYE
- Class II
Aug 26, 2026
K260407
Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
Principle & Will Co., Ltd.
- FYA
- Class II
Aug 26, 2026
K254103
HOPKINS Telescopes for Arthroscopy
Karl Storz SE & CO. KG
- HRX
- Class II
Aug 26, 2026
K253877
StimTrial Neuromodulation System
Bioventus, LLC
- GZF
- Class II
Aug 26, 2026
K253715
Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)
Maquet Critical Care AB
- PIF
- Class II
Aug 25, 2026
K262631
Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
SteriLance Medical (Suzhou), Inc.
- QRK
- Class II
Aug 25, 2026
K261747
Report Studio
Beacon Biosignals, Inc.
- OLV
- Class II
Aug 25, 2026
K261719
Promisemed X-Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd.
- FMI
- Class II
Aug 25, 2026
K261595
Ceevra Reveal 4
Ceevra, Inc.
- QIH
- Class II
Aug 25, 2026
K261514
Calcium Hydroxide Temporary Filling Material (KP-Cal)
Guilin Kevin Peter Technology Co., Ltd.
- KIF
- Class II