FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
145–168 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jun 12, 2026
Disposable Blood Lancet (Soft)
K261634 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 25d
Cleared Jun 12, 2026
Virtus
K261366 · LRK
Somnomed, Inc.
Dental · 46d
Cleared Jun 12, 2026
Medical Monitor (40HT513D)
K261213 · PGY
Lg Electronics.Inc
Radiology · 59d
Cleared Jun 12, 2026
Exalta Proximal Tibia Plating System
K261207 · HRS
Tyber Medical, LLC
Orthopedic · 60d
Cleared Jun 12, 2026
Intense Pulsed Light Therapy Device
K261204 · ONF
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 60d
Cleared Jun 12, 2026
WHILL (WHILL Model C2)
K261175 · ITI
Whill, Inc.
Physical Medicine · 63d
Cleared Jun 12, 2026
Stelo Glucose Biosensor System
K260935 · SBH
Dexcom, Inc.
Chemistry · 84d
Cleared Jun 12, 2026
HARBOR Occlusion Device
K260635 · KRD
Nuvascular, Inc.
Cardiovascular · 106d
Cleared Jun 12, 2026
Profoject™ Safety Needle
K260514 · FMF
CMT Health PTE., Ltd.
General Hospital · 115d
Cleared Jun 12, 2026
Brainomix 360 Hyperdensity
K260406 · QIH
Brainomix Limited
Radiology · 123d