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
337–360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2026
BMD Titanium Spinal Fusion System
K253894 · MAX
Global Biomedica s.r.o.
Orthopedic · 175d
Cleared May 28, 2026
Trexon™ Monofilament Synthetic Absorbable Suture
K253530 · GAM
Medtronic
General & Plastic Surgery · 196d
Cleared May 28, 2026
Dukal Crepe Paper Sterilization Wrap
K252823 · FRG
Dukal, LLC
General Hospital · 266d
Cleared May 28, 2026
STIMPOD NMS460 Nerve Stimulator
K252712 · GZJ
Algiamed Technologies USA, Inc.
Neurology · 274d
Cleared May 28, 2026
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF,...
K252702 · DQO
Bioptimal International Pte. , Ltd.
Cardiovascular · 274d
Cleared May 28, 2026
Zimmer® Persona® Personalized Knee System
K251840 · MBH
Zimmer, Inc.
Orthopedic · 346d
Cleared May 27, 2026
LigaPASS™ System
K261374 · OWI
Medicrea International S.A.S
Orthopedic · 30d
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