Sep 17, 2026
K262091
FRAXION Spinal Fixation System
Ortler Global Tibbi Gerecler Anonim Sirketi
- NKB
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 17, 2026
K262073
Hygienic Protective Bite Cover (2207-010-50)
Dürr Dental SE
- PEM
- Class II
Sep 17, 2026
K261959
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)
Stryker Instruments
- GEI
- Class II
Sep 17, 2026
K261869
Integrity Retractable Implant Inserter (6000127)
Anika Therapeutics, Inc.
- MBI
- Class II
Sep 17, 2026
K261817
Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
- GEX
- Class II
Sep 17, 2026
K261729
EnSite™ X EP System
Abbott Medical
- DQK
- Class II
Sep 17, 2026
K261673
LED Therapy Device (QLXY-01)
Beijing Nubway S&T Co., Ltd.
- GEX
- Class II
Sep 17, 2026
K261392
TriActive Dental Implant System
Paragon Implant Mfg., LLC
- DZE
- Class II
Sep 17, 2026
K261275
Unity Total Knee System, Unity Knee Cementless CR Femur
Corin, Ltd.
- MBH
- Class II
Sep 17, 2026
K261266
MOWANA™ Auto Duo
PENTAMASTER MEDIQ SDN BHD
- FMI
- Class II
Sep 17, 2026
K260677
Vessel Closure Device (VCD177213P)
Vcd Medical S.R.L.
- FZP
- Class II
Sep 17, 2026
K260173
M-Vizion Femoral Revision System Extension
Medacta International S.A.
- LZO
- Class II
Sep 17, 2026
K254260
The VEGA Cervical Screw System
GS Medical Co., Ltd.
- NKG
- Class II
Sep 17, 2026
K254203
Wearable Breast Pump (Model S36)
Shenzhen TPH Technology Co., Ltd.
- HGX
- Class II
Sep 17, 2026
K254196
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
Ethicon Endo-Surgery, LLC
- GEI
- Class II
Sep 17, 2026
K252995
Durashield Device Kit
SurGenTec, LLC
- GZT
- Class II
Sep 16, 2026
K262877
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Olympus Surgical Technologies America
- GEX
- Class II
Sep 16, 2026
K262559
Mouth Guard
ChangSha ChuangDuoLe E-Commerce Co., Ltd.
- OBR
- Unclassified
Sep 16, 2026
K262054
Electric Wheelchair
Yongkang Joymax Medical Technology Co., Ltd.
- ITI
- Class II
Sep 16, 2026
K261919
Multifunctional wheelchair (YJ-059)
Zhenjiang Assure Medical Equipment Co., Ltd.
- IOR
- Class I
Sep 16, 2026
K261913
X°Port Heart Preservation System
Traferox Technologies, Inc.
- MSB
- Class II
Sep 16, 2026
K261896
iOS CamAPS FX
CamDiab
- QJI
- Class II
Sep 16, 2026
K261888
ClearClub Impression Material
ClearClub
- SHI
- Class II
Sep 16, 2026
K261865
AerFrame™ Alignment Laser Box (LBV2)
Stabilix, LLC
- IYE
- Class II
Sep 16, 2026
K261778
JADE SCORE PTA Scoring Balloon Dilatation Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd.
- PNO
- Class II