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
265–288 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 01, 2026
Transcend Bulk Fill Flowable Composite
K262228 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Jul 01, 2026
Trevo Trak 21 Microcatheter
K261889 · QJP
Stryker Neurovascular
Neurology · 26d
Cleared Jul 01, 2026
OTS Hip
K261852 · OLO
Ortoma AB
Orthopedic · 28d
Cleared Jul 01, 2026
Tetric plus Fill
K261485 · EBF
Ivoclar Vivadent, Inc.
Dental · 57d
Cleared Jul 01, 2026
DENTCA Tru Flexible
K261474 · EBI
Dentca, Inc.
Dental · 58d
Cleared Jul 01, 2026
Chromix
K261473 · OHS
Termosalud S.L.
General & Plastic Surgery · 58d
Cleared Jul 01, 2026
Neodent Implant System - NeoConvert Fit
K261147 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 85d
Cleared Jul 01, 2026
RibPlate System
K261054 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 92d
Cleared Jul 01, 2026
EasyWhip Family
K261021 · GAT
Winter Innovations, Inc.
General & Plastic Surgery · 96d
Cleared Jul 01, 2026
Veritas Shoulder System
K260556 · PHX
Restor3d
Orthopedic · 132d
Cleared Jul 01, 2026
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)
K254056 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 196d
Cleared Jul 01, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253802 · NKB
S.M.A.I.O
Orthopedic · 215d
Cleared Jul 01, 2026
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)
K253527 · GAG
Covidien, LLC
General & Plastic Surgery · 230d
Cleared Jul 01, 2026
OSSTM Orthopedic Salvage System
K253434 · JDI
Biomet, Inc.
Orthopedic · 273d
Cleared Jul 01, 2026
Admiral ACP System
K253420 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 273d
Cleared Jul 01, 2026
Enteral Syringe (20ml, 60ml)
K252483 · PNR
Chirana T.Injecta,A.S.
Gastroenterology & Urology · 328d
Cleared Jun 27, 2026
MIST IC
K261122 · NHA
Imagine Milling Technologies, LLC
Dental · 85d
Cleared Jun 27, 2026
SOMNUM (SOMNUM)
K253390 · OLZ
Honeynaps Co., Ltd.
Neurology · 270d
Cleared Jun 27, 2026
BraiN20® (BraiN20)
K253301 · GWF
Time IS Brain, S.L.
Neurology · 271d
Cleared Jun 26, 2026
LightningWire Transseptal Puncture System (TPS)
K261745 · DXF
ElectroWire Medical
Cardiovascular · 30d
Cleared Jun 26, 2026
Arterial Pressure Monitoring Set/Tray
K261455 · DQO
Spectrum Vascular
Cardiovascular · 56d
Cleared Jun 26, 2026
Charlotte ACC25 Surface Electrode Array
K261442 · GXY
Cadwell Industries, Inc.
Neurology · 57d
Cleared Jun 26, 2026
SALGINA 2.5mm Distal Radius System
K261351 · HRS
Bonebridge AG
Orthopedic · 63d
Cleared Jun 26, 2026
Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7,...
K261253 · OAP
Ziree Co., Ltd.
General & Plastic Surgery · 71d