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: 2026–2026 ×
1,922 results
625–648 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 27, 2026
EPIQ Series Diagnostic Ultrasound Systems
K260680 · IYN
Philips Ultrasound, LLC
Radiology · 86d
Cleared May 27, 2026
RENASYS EDGE (66803126)
K260646 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 89d
Cleared May 27, 2026
Portable Dental X-ray System Model PDX nova
K260367 · EHD
PDX Co., Ltd.
Radiology · 112d
Cleared May 27, 2026
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
K260207 · MUJ
Philips Medical Systems Nederland B.V.
Radiology · 124d
Cleared May 27, 2026
StimelMD (SSMD) system
K260142 · IPF
Motion Informatics ltd.
Physical Medicine · 127d
Cleared May 27, 2026
EPIQ Series Diagnostic Ultrasound System
K260123 · IYN
Philips Ultrasound, LLC
Radiology · 132d
Cleared May 27, 2026
Helion Viewer Suite
K254265 · LLZ
Videomed Srl ( a Baxter Healthcare...
Radiology · 148d
Cleared May 27, 2026
ResScan Essentials
K254104 · BZD
ResMed Corp
Anesthesiology · 159d
Cleared May 27, 2026
Glucommander
K254102 · NDC
Glytec, LLC
Chemistry · 159d
Cleared May 27, 2026
Synapse Lung Nodule AI
K254075 · OEB
Fujifilm Corporation
Radiology · 160d
Cleared May 27, 2026
Visby Medical Flu and COVID-19 Test
K253971 · SIA
Visby Medical, Inc.
Microbiology · 167d
Cleared May 27, 2026
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
K253212 · GKZ
Sysmex America, Inc.
Hematology · 240d
Cleared May 27, 2026
Dione PEEK Screw System
K253130 · MBI
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 244d
Cleared May 27, 2026
AQUA Laminoplasty Systems
K252930 · NQW
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 254d
Cleared May 26, 2026
LOGIQ e
K260398 · IYN
GE Medical Systems Ultrasound and...
Radiology · 109d
Cleared May 26, 2026
4K NIR/ICG Imaging System
K260318 · GCJ
Zhejiang Healnoc Technology Co., Ltd.
General & Plastic Surgery · 116d
Cleared May 26, 2026
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
K254157 · OLO
Medos International SARL
Orthopedic · 155d
Cleared May 26, 2026
Momcozy Nasal Aspirator (BN007)
K253629 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 188d
Cleared May 26, 2026
VIVA combo RF System
K252833 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 263d
Cleared May 26, 2026
JAZBI™ Resorbable Bone Void Filler
K252797 · MQV
Sdip Innovations Pty, Ltd.
Orthopedic · 265d
Cleared May 26, 2026
Digital ClarusScope System and Digital NeuroPEN System
K252790 · HRX
Clarus Medical, LLC
Orthopedic · 266d
Cleared May 24, 2026
MediBot Needle Driver Uno
K260183 · GCJ
Parallel Robotics, LLC
General & Plastic Surgery · 123d
Cleared May 22, 2026
BioSieve Multi-Drug Urine Test Panel
K261280 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 35d
Cleared May 22, 2026
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens...
K261098 · KOI
Senzime AB
Anesthesiology · 50d