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: 2026–2026 ×
2,517 results
625–648 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 30, 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral...
K261410 · OLO
Suite 201, National Innovation Centre
Orthopedic · 91d
Cleared Jul 30, 2026
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
K261389 · CCL
Salter Labs
Anesthesiology · 93d
Cleared Jul 30, 2026
Handheld Ultrasound Scanner
K261288 · IYN
IMGFAX CO., LTD.
Radiology · 101d
Cleared Jul 30, 2026
cmAngio® V2.0
K260980 · QIH
Curemetrix, Inc.
Radiology · 127d
Cleared Jul 30, 2026
Arthrex Radial Head Replacement System
K260624 · KWI
Arthrex, Inc.
Orthopedic · 154d
Cleared Jul 30, 2026
SeptAlign (SPLN001)
K260620 · NHB
Spirair, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 30, 2026
SMARTVERTIGO™ Vestibular Assessment System
K260566 · GWN
VertigoDx, Inc.
Ear, Nose, Throat · 161d
Cleared Jul 30, 2026
SmartGuide Disposable Guides and Grids
K260161 · ITX
UC-CARE , Ltd.
Radiology · 191d
Cleared Jul 30, 2026
Motivista (CT-155)
K254038 · SAP
Click Therapeutics, Inc.
Neurology · 226d
Cleared Jul 30, 2026
Sync AV II Temporary Pacing Catheter
K252042 · LDF
Swift Sync, Inc.
Cardiovascular · 395d
Cleared Jul 30, 2026
TnR Cranial Implant
K251959 · GXP
T&R BIOFAB CO., Ltd.
Neurology · 399d
Cleared Jul 29, 2026
SSPC NXT Delivery Catheter
K262240 · DQY
CenterPoint Systems, LLC
Cardiovascular · 28d
Cleared Jul 29, 2026
Stone Clear (BWSC-LP9-02)
K262200 · QNA
Sonomotion, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 29, 2026
Profoject™ Dual-Safety Pen Needles
K261829 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d
Cleared Jul 29, 2026
Suture Button Repair System
K261770 · MBI
Skeletal Dynamics, Inc.
Orthopedic · 61d
Cleared Jul 29, 2026
CPS Locator 3D Plus Delivery Catheter
K261766 · DQY
CenterPoint Systems, LLC
Cardiovascular · 62d
Cleared Jul 29, 2026
Cleerly Plaque
K261210 · QIH
Cleerly, Inc.
Radiology · 106d
Cleared Jul 29, 2026
SPINEART Navigation Instrument System
K261205 · OLO
Spineart SA
Orthopedic · 107d
Cleared Jul 29, 2026
CraniUS Plate
K261058 · GWO
CraniUS, LLC
Neurology · 120d
Cleared Jul 29, 2026
Cleerly LABS
K260588 · LLZ
Cleerly, Inc.
Radiology · 159d
Cleared Jul 29, 2026
NAMIC Dilator and Sheath
K253526 · DYB
Medline Industries, LP
Cardiovascular · 258d
Cleared Jul 29, 2026
Emanate Tray
K251908 · OLR
Emanate Biomedical
Dental · 404d
Cleared Jul 28, 2026
Xpert Ankle
K261511 · HRS
Newclip Technics
Orthopedic · 82d
Cleared Jul 28, 2026
TruLift Expandable System
K261430 · MAX
Life Spine, Inc.
Orthopedic · 89d