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
433–456 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared Jun 15, 2026
MediAI-OA
K253172 · QIH
Crescom Co., Ltd.
Radiology · 262d
Cleared Jun 15, 2026
Fule Interbody Fusion Cage System
K253151 · MAX
Beijing Fule Science & Technology...
Orthopedic · 262d
Cleared Jun 15, 2026
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte...
K253121 · MQE
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 263d
Cleared Jun 15, 2026
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
K253059 · DXN
Tournicare Pty, Ltd.
Cardiovascular · 266d
Cleared Jun 13, 2026
Enobio Dx (Enobio Dx 8)
K261604 · GWQ
Neuroelectrics Barcelona S.L.U.
Neurology · 30d
Cleared Jun 12, 2026
Disposable Blood Lancet (Soft)
K261634 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 25d
Cleared Jun 12, 2026
Virtus
K261366 · LRK
Somnomed, Inc.
Dental · 46d
Cleared Jun 12, 2026
Medical Monitor (40HT513D)
K261213 · PGY
Lg Electronics.Inc
Radiology · 59d
Cleared Jun 12, 2026
Exalta Proximal Tibia Plating System
K261207 · HRS
Tyber Medical, LLC
Orthopedic · 60d
Cleared Jun 12, 2026
Intense Pulsed Light Therapy Device
K261204 · ONF
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 60d
Cleared Jun 12, 2026
WHILL (WHILL Model C2)
K261175 · ITI
Whill, Inc.
Physical Medicine · 63d
Cleared Jun 12, 2026
Stelo Glucose Biosensor System
K260935 · SBH
Dexcom, Inc.
Chemistry · 84d
Cleared Jun 12, 2026
HARBOR Occlusion Device
K260635 · KRD
Nuvascular, Inc.
Cardiovascular · 106d
Cleared Jun 12, 2026
Profoject™ Safety Needle
K260514 · FMF
CMT Health PTE., Ltd.
General Hospital · 115d
Cleared Jun 12, 2026
Brainomix 360 Hyperdensity
K260406 · QIH
Brainomix Limited
Radiology · 123d
Cleared Jun 12, 2026
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701,...
K260346 · HGX
Polybell (Guangzhou) Limited
Obstetrics & Gynecology · 129d
Cleared Jun 12, 2026
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented...
K260102 · PHX
Stryker Corporation (Tornier, Inc.)
Orthopedic · 150d
Cleared Jun 12, 2026
MEDRAD® Imaging Bulk Package Transfer Spike
K253688 · PQH
Bayer Medical Care, Inc.
General Hospital · 203d
Cleared Jun 12, 2026
Spiro-VISTA
K253437 · BTR
Spiro Robotics
Anesthesiology · 254d
Cleared Jun 12, 2026
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300,...
K253196 · MWI
Midmark Corporation
Cardiovascular · 259d
Cleared Jun 12, 2026
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
K253088 · DQK
Micropace Pty, Ltd.
Cardiovascular · 262d
Cleared Jun 12, 2026
Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
K253015 · OLU
VoxNeuro, Inc.
Neurology · 266d
Cleared Jun 12, 2026
Universal 1417PI
K252996 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 267d