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: Cleared only ×
174,955 results
2881–2904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2025
SABER-C System
K250540 · OVE
Elevation Spine
Orthopedic · 165d
Cleared Aug 08, 2025
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
K250472 · KTT
Amdt Holdings, Inc.
Orthopedic · 171d
Cleared Aug 08, 2025
Water-based Lubricant
K250142 · NUC
Global Protection Corp.
Obstetrics & Gynecology · 203d
Cleared Aug 08, 2025
Plain Water-based Lubricant
K243972 · NUC
Global Protection Corp.
Obstetrics & Gynecology · 228d
Cleared Aug 08, 2025
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
K243531 · JXG
Integra Lifesciences Production...
Neurology · 267d
Cleared Aug 08, 2025
MICOR 700 with Auto I/A
K243395 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 281d
Cleared Aug 08, 2025
Parkell Pit and Fissure Sealant
K243254 · EBC
Parkell, Inc.
Dental · 297d
Cleared Aug 07, 2025
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
K251667 · OHS
Shenzhen Liyoutong Technology Co., Ltd.
General & Plastic Surgery · 69d
Cleared Aug 07, 2025
UNiD™ Spine Analyzer
K251629 · QIH
Medicrea International S.A.S....
Radiology · 71d
Cleared Aug 07, 2025
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · GXD
Boston Scientific Neuromodulation...
Neurology · 106d
Cleared Aug 07, 2025
Navigo Workstation 2.3 (FPRMC00039)
K250664 · LLZ
UC-CARE , Ltd.
Radiology · 155d
Cleared Aug 07, 2025
Succession™ AFN System
K250622 · HSB
Ortho Solutions UK , Ltd.
Orthopedic · 160d
Cleared Aug 07, 2025
BTL-199
K250309 · QPL
BTL Industries, Inc.
Physical Medicine · 185d
Cleared Aug 07, 2025
LuMon(TM) System
K243765 · QEB
Sentec AG
Anesthesiology · 244d
Cleared Aug 07, 2025
Longboard Revision Hip Stem
K243021 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 314d
Cleared Aug 06, 2025
InterSpace GV Hip Spacer
K252326 · KWL
Tecres S.P.A.
Orthopedic · 12d
Cleared Aug 06, 2025
InVision™ 3T Recharge Operating Suite
K252239 · LNH
Imris Imaging, Inc.
Radiology · 20d
Cleared Aug 06, 2025
SteadiSet infusion set
K251854 · FPA
Tandem Diabetes Care
Chemistry · 50d
Cleared Aug 06, 2025
Olo
K251432 · GEX
El.En S.P.A.
General & Plastic Surgery · 90d
Cleared Aug 06, 2025
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP...
K251120 · DXN
Microlife Corporation
Cardiovascular · 117d
Cleared Aug 06, 2025
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
K251038 · LLZ
Shen Zhen Cambridge-Hit Co., Ltd.
Radiology · 125d
Cleared Aug 06, 2025
Cardiologs Holter Platform
K250569 · DPS
Philips France Commercial
Cardiovascular · 161d
Cleared Aug 06, 2025
Viction Disposable Irrigation and suction System (VC-FLA0514
K250130 · GCJ
Hangzhou Viction Medical Technology...
General & Plastic Surgery · 201d
Cleared Aug 06, 2025
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523,...
K250124 · GCJ
Hangzhou Viction Medical Technology...
General & Plastic Surgery · 201d