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
3865–3888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2025
Optilite® Freelite Mx Kappa Free Kit
K250549 · DFH
The Binding Site Group , Ltd.
Immunology · 87d
Cleared May 23, 2025
Knotilus+ Biocomposite Knotless Anchor
K250544 · MAI
Stryker Endoscopy
Orthopedic · 87d
Cleared May 23, 2025
Frida™ Anterior Cervical Plate System
K250446 · KWQ
Spineup, Inc.
Orthopedic · 98d
Cleared May 23, 2025
IPL400
K250384 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 101d
Cleared May 23, 2025
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
K250361 · NFO
Geske Beauty Tech GmbH
Neurology · 102d
Cleared May 23, 2025
NeuroMatch
K250239 · OLX
LVIS Corporation
Neurology · 116d
Cleared May 23, 2025
Clever One
K250005 · QIH
Ewoosoft Co., Ltd.
Radiology · 141d
Cleared May 23, 2025
Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · JKA
Venocare, Inc.
General Hospital · 143d
Cleared May 23, 2025
Second Opinion® 3D
K243989 · QIH
Pearl, Inc.
Radiology · 148d
Cleared May 23, 2025
Accuro 3S
K243937 · IYO
Rivanna Medical, Inc.
Radiology · 154d
Cleared May 23, 2025
MagnetOs MIS
K243474 · MQV
Kuros Biosciences B.V
Orthopedic · 196d
Cleared May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
K243261 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 220d
Cleared May 23, 2025
WiZARD 520 Full Face Mask
K243023 · BZD
Wellell, Inc.
Anesthesiology · 238d
Cleared May 23, 2025
DEEPECHO
K242594 · IYN
Deepecho
Radiology · 266d
Cleared May 23, 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
K242575 · HAW
Brain Navi Biotechnology Co., Ltd.
Neurology · 267d
Cleared May 23, 2025
RadiForce MX317W-PA
K242545 · PZZ
Eizo Corporation
Pathology · 269d
Cleared May 22, 2025
Skin Clinic Freeze Point for Warts and Skin Tags
K251493 · GEH
Cryoconcepts LP
General & Plastic Surgery · 7d
Cleared May 22, 2025
Trivicta® Hip Stem
K251052 · MEH
Ortho Development Corp.
Orthopedic · 49d
Cleared May 22, 2025
Physica System (Physica CR Porous Femoral components)
K250980 · MBH
Lima Corporate S.P.A.
Orthopedic · 52d
Cleared May 22, 2025
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate)
K250935 · HRS
TriMed, Inc.
Orthopedic · 55d
Cleared May 22, 2025
Arthrex Spine Compression FT Screw
K250920 · MRW
Arthrex, Inc.
Orthopedic · 56d
Cleared May 22, 2025
Optilume® High Pressure Urological Balloon Dilation Catheter
K250910 · EZN
Urotronic, Inc.
Gastroenterology & Urology · 57d
Cleared May 22, 2025
Koala Intrauterine Pressure Catheter (IPC-5000E)
K250897 · HFN
Clinical Innovations, LLC
Obstetrics & Gynecology · 58d
Cleared May 22, 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 59d