FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
169–192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2026
EnSite™ X EP System
K261729 · DQK
Abbott Medical
Cardiovascular · 114d
Cleared Sep 17, 2026
LED Therapy Device (QLXY-01)
K261673 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 119d
Cleared Sep 17, 2026
TriActive Dental Implant System
K261392 · DZE
Paragon Implant Mfg., LLC
Dental · 141d
Cleared Sep 17, 2026
Unity Total Knee System, Unity Knee Cementless CR Femur
K261275 · MBH
Corin, Ltd.
Orthopedic · 153d
Cleared Sep 17, 2026
MOWANA™ Auto Duo
K261266 · FMI
PENTAMASTER MEDIQ SDN BHD
General Hospital · 154d
Cleared Sep 17, 2026
Vessel Closure Device (VCD177213P)
K260677 · FZP
Vcd Medical S.R.L.
Cardiovascular · 199d
Cleared Sep 17, 2026
M-Vizion Femoral Revision System Extension
K260173 · LZO
Medacta International S.A.
Orthopedic · 239d
Cleared Sep 17, 2026
The VEGA Cervical Screw System
K254260 · NKG
GS Medical Co., Ltd.
Orthopedic · 262d
Cleared Sep 17, 2026
Wearable Breast Pump (Model S36)
K254203 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 262d
Cleared Sep 17, 2026
HARMONIC 1100 Shears (HAR1120)
K254196 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 268d
Cleared Sep 17, 2026
Durashield Device Kit
K252995 · GZT
SurGenTec, LLC
Neurology · 364d
Cleared Sep 16, 2026
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K262877 · GEX
Olympus Surgical Technologies America
Gastroenterology & Urology · 30d
Cleared Sep 16, 2026
Mouth Guard
K262559 · OBR
ChangSha ChuangDuoLe E-Commerce Co.,...
Dental · 54d
Cleared Sep 16, 2026
Electric Wheelchair
K262054 · ITI
Yongkang Joymax Medical Technology...
Physical Medicine · 90d
Cleared Sep 16, 2026
Multifunctional wheelchair (YJ-059)
K261919 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 99d
Cleared Sep 16, 2026
X°Port Heart Preservation System
K261913 · MSB
Traferox Technologies, Inc.
Cardiovascular · 100d
Cleared Sep 16, 2026
iOS CamAPS FX
K261896 · QJI
CamDiab
Chemistry · 100d
Cleared Sep 16, 2026
ClearClub Impression Material
K261888 · SHI
ClearClub
Dental · 103d
Cleared Sep 16, 2026
AerFrame™ Alignment Laser Box (LBV2)
K261865 · IYE
Stabilix, LLC
Radiology · 104d
Cleared Sep 16, 2026
JADE SCORE PTA Scoring Balloon Dilatation Catheter
K261778 · PNO
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 110d
Cleared Sep 16, 2026
Embrace Vision Neonatal MRI System
K261758 · LNH
Aspect Imaging, Ltd.
Radiology · 111d
Cleared Sep 16, 2026
Ceribell EEG Analysis Software
K261712 · OLT
Ceribell, Inc.
Neurology · 117d
Cleared Sep 16, 2026
EchoPAC Software Only / EchoPAC Plug-in (v211)
K261623 · QIH
GE Medical Systems Ultrasound and...
Radiology · 124d
Cleared Sep 16, 2026
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05,...
K261467 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 135d