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
25–48 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
K262369 · MBI
Stryker Endoscopy
Orthopedic · 20d
Cleared Jul 30, 2026
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS...
K262330 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 21d
Cleared Jul 30, 2026
Obsidian® Press Over Zirconia
K262239 · EIH
Prismatik Dentalcraft, Inc.
Dental · 29d
Cleared Jul 30, 2026
LOGIQ Focus
K261835 · IYN
GE Medical Systems Ultrasound and...
Radiology · 58d
Cleared Jul 30, 2026
neXus Ultrasonic Surgical Aspirator System
K261448 · LFL
Misonix, LLC
General & Plastic Surgery · 90d
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