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
1561–1584 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Feb 19, 2026
Valence Robotic Navigation System
K252597 · OLO
Alphatec Spine, Inc.
Orthopedic · 188d
Cleared Feb 19, 2026
Monaco RTP System (6.3)
K252002 · MUJ
Elekta Solutions AB
Radiology · 237d
Cleared Feb 19, 2026
Erchonia DPN Laser (Model# EVRL)
K251903 · NHN
Erchonia Corporation
Physical Medicine · 244d
Cleared Feb 18, 2026
1688 4K Camera System with Advanced Imaging Modality
K260185 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 28d
Cleared Feb 18, 2026
Mobility Scooter (S3)
K253643 · INI
Shenzhen Zhimahuaerkai Technology...
Physical Medicine · 91d
Cleared Feb 18, 2026
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial...
K253637 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 91d
Cleared Feb 18, 2026
Alere NT-proBNP for Alinity i
K253539 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 97d
Cleared Feb 18, 2026
BTL-754FF
K252561 · GEX
BTL Industries, Inc.
General & Plastic Surgery · 189d
Cleared Feb 18, 2026
Nobel Biocare S Series Implants
K252197 · DZE
Nobel Biocare AB
Dental · 219d
Cleared Feb 18, 2026
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098 · MEG
Methyl Co., Ltd.
General Hospital · 230d
Cleared Feb 17, 2026
Versus™ Catheter (VS110-9NB)
K260149 · QEY
Liquet Medical, Inc.
Cardiovascular · 28d
Cleared Feb 17, 2026
IOPS Visionary System (MC-3)
K254089 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 60d
Cleared Feb 17, 2026
Electric Wheelchair (W-A807, W-A807L)
K253599 · ITI
Ningbo Shenyu Medical Equipment Co.,Ltd
Physical Medicine · 91d
Cleared Feb 17, 2026
Adaptos®Fuse Bone Graft
K253524 · MQV
Biomendex OY
Orthopedic · 96d
Cleared Feb 17, 2026
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · DQA
Jiangsu Yuyue Medical Equipment&...
Anesthesiology · 167d
Cleared Feb 17, 2026
Biosteon® Screw
K251680 · MAI
Biocomposites, Ltd.
Orthopedic · 263d
Cleared Feb 17, 2026
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K250550 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 357d
Cleared Feb 13, 2026
Willow 18 Guidewire
K260130 · MOF
Arbor Endovascular, LLC
Neurology · 28d
Cleared Feb 13, 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105 · ODP
NanoHive Medical, LLC
Orthopedic · 56d
Cleared Feb 13, 2026
DAILIES TOTAL1®
K254052 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 58d
Cleared Feb 13, 2026
uMI Panvivo (uMI Panvivo)
K253564 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Feb 13, 2026
Motion InBra (YM-8801) wearable breast pump
K253149 · HGX
Medela, LLC
Obstetrics & Gynecology · 141d
Cleared Feb 13, 2026
Wrist Blood Pressure Monitor (BPM-W1VL)
K253133 · DXN
Shenzhen Imdk Medical Technology Co.,...
Cardiovascular · 141d
Cleared Feb 13, 2026
Chartis Precision Catheter
K253096 · CBI
Pulmonx Corporation
Anesthesiology · 143d