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
169–192 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 16, 2026
Socrates Aspiration System (Socrates 70 Aspiration Catheter)
K260002 · NRY
Scientia Vascular, Inc.
Neurology · 195d
Cleared Jul 15, 2026
Aventus Thrombectomy System
K262030 · QEZ
Inquis Medical
Cardiovascular · 28d
Cleared Jul 15, 2026
EnSite™ X EP System
K262006 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Jul 15, 2026
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368,...
K261407 · OHS
Dongguan Miqiang Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Jul 15, 2026
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System
K261353 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 82d
Cleared Jul 15, 2026
Better Diagnostics Dental Assist (BDDA) Version 1.0
K260851 · MYN
Better Diagnostics AI Corp.
Radiology · 121d
Cleared Jul 15, 2026
Profoject™ Pen Needles (Model A
K260739 · FMI
CMT Health PTE., Ltd.
General Hospital · 131d
Cleared Jul 15, 2026
ThinkSono Guidance
K260338 · QJU
ThinkSono GmbH
Radiology · 163d
Cleared Jul 15, 2026
SkeletonPlanner
K260206 · QIH
UPlanner B.V. - Presurgeo
Radiology · 173d
Cleared Jul 15, 2026
WRAP System
K260050 · MNR
Huneo, LLC
Neurology · 189d
Cleared Jul 15, 2026
NanoZoomer S20MD Slide scanner system
K253606 · PSY
Hamamatsu Photonics K.K.
Pathology · 239d
Cleared Jul 15, 2026
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
K252822 · PLR
Atlas Spine, Inc.
Orthopedic · 314d
Cleared Jul 14, 2026
VisuBreath
K261633 · CCK
Affirm Medical Technologies II, LLC
Anesthesiology · 57d
Cleared Jul 14, 2026
Invictus® Small Stature Spinal Fixation System
K261284 · NKB
Alphatec Spine, Inc.
Orthopedic · 88d
Cleared Jul 14, 2026
Universal Seal (5-12 mm)
K261249 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 14, 2026
IERO Mobility Scooter (IERO-01)
K261232 · INI
Jochu Technology Co., Ltd.
Physical Medicine · 90d
Cleared Jul 14, 2026
Symmetrix™ L Spinal System
K261020 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 109d
Cleared Jul 14, 2026
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US,...
K260578 · GXY
Ambu A/S
Neurology · 144d
Cleared Jul 14, 2026
Accoat Guide Wire
K253667 · DQX
Sp Medical A/S
Cardiovascular · 235d
Cleared Jul 14, 2026
LIXI (LXOSFM1)
K253662 · MSC
Luwi, LLC
Obstetrics & Gynecology · 236d
Cleared Jul 13, 2026
Merit MAK Nitinol/Gold-Tungsten Guide Wire
K261640 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 56d
Cleared Jul 13, 2026
Wearable Breast Pump (Model S32A)
K261199 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Jul 13, 2026
Rapid Vessel Occlusion (Rapid VO)
K261085 · QAS
Ischemaview
Radiology · 103d
Cleared Jul 13, 2026
Ultra-Fine™ SAFETY Insulin Syringe
K260208 · FMF
embecta Medical II, LLC
General Hospital · 171d