FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
409–432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2026
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352,...
K253231 · OAP
Hubei Yjt Technology Co.,Ltd
General & Plastic Surgery · 260d
Cleared Jun 16, 2026
Prophecy Incompass Surgical Planning System
K253159 · HSN
Wright Medical Technology, Inc....
Orthopedic · 263d
Cleared Jun 16, 2026
FUJIFILM Endoscope Model EB-840S
K253137 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 264d
Cleared Jun 16, 2026
Lipoprotein (a) Molarity Assay
K253069 · DFC
Diazyme Laboratories, Inc.
Chemistry · 266d
Cleared Jun 16, 2026
HERA Interlocking Intramedullary Nailing System
K253046 · HSB
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 267d
Cleared Jun 16, 2026
KT Airway Clearance Device II (KT-3)
K253001 · NHJ
Hunan Ruijiong Biotech Co., Ltd.
Anesthesiology · 270d
Cleared Jun 15, 2026
Permatage XT Settable Bone Putty
K261265 · GXP
Orthocon, Inc.
Neurology · 60d
Cleared Jun 15, 2026
VERAFEYE Imaging and Guidance System (VF-VIS-002)
K260885
Luma Vision Limited
Cardiovascular · 90d
Cleared Jun 15, 2026
DRE Duo
K260482 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 122d
Cleared Jun 15, 2026
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152,...
K260452 · LXB
Zdeer Technology (Henan) Co., Ltd.
Ear, Nose, Throat · 124d
Cleared Jun 15, 2026
Electric Wheelchair (S500-6)
K260335 · ITI
Zhongshan Sulenz Intelligent...
Physical Medicine · 133d
Cleared Jun 15, 2026
LIAISON NES Group A Strep
K260333 · PGX
Diasorin Molecular, LLC
Microbiology · 133d
Cleared Jun 15, 2026
WatchMate Software
K260300 · QIH
Anumana, Inc.
Radiology · 136d
Cleared Jun 15, 2026
Dynamo™ Spinal Cement
K260286 · PML
Spine Wave, Inc.
Orthopedic · 137d
Cleared Jun 15, 2026
Curajel™ Oral Gel
K260126 · OLR
USpharma, Ltd.
Dental · 151d
Cleared Jun 15, 2026
NeckTune™ 3D SA Cervical Cage
K260036 · OVE
Medyssey Co, Ltd.
Orthopedic · 160d
Cleared Jun 15, 2026
Neodent Scannable Healing Abutment
K253922 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 189d
Cleared Jun 15, 2026
Saige-Dx
K253825 · QDQ
DeepHealth, Inc.
Radiology · 196d
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared Jun 15, 2026
MediAI-OA
K253172 · QIH
Crescom Co., Ltd.
Radiology · 262d
Cleared Jun 15, 2026
Fule Interbody Fusion Cage System
K253151 · MAX
Beijing Fule Science & Technology...
Orthopedic · 262d
Cleared Jun 15, 2026
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte...
K253121 · MQE
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 263d
Cleared Jun 15, 2026
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
K253059 · DXN
Tournicare Pty, Ltd.
Cardiovascular · 266d
Cleared Jun 13, 2026
Enobio Dx (Enobio Dx 8)
K261604 · GWQ
Neuroelectrics Barcelona S.L.U.
Neurology · 30d