FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
841–864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2026
OptraSCAN System
K260755 · NOT
Optrascan, Inc.
Pathology · 115d
Cleared Jul 02, 2026
Collagen Wound Powder
K260596 · KGN
Ventris Medical
General & Plastic Surgery · 128d
Cleared Jul 02, 2026
OncoStudio
K260528 · QKB
Oncosoft. Inc.,
Radiology · 135d
Cleared Jul 02, 2026
FACE4D Aligner
K260527 · NXC
Avinent Implant System S.L.U.
Dental · 135d
Cleared Jul 02, 2026
Koios DS (3.8)
K253884 · POK
Koios Medical, Inc.
Radiology · 210d
Cleared Jul 02, 2026
iPredict-DR
K253704 · PIB
iHealthscreen, Inc.
Ophthalmic · 220d
Cleared Jul 02, 2026
ILR ECG Analyzer (IM007)
K253463 · DQK
Implicity, Inc.
Cardiovascular · 267d
Cleared Jul 02, 2026
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
K252463 · DPS
Edan Instruments, Inc.
Cardiovascular · 330d
Cleared Jul 02, 2026
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit
K252243 · OYX
Suzhou Precigenome, Ltd. Co;
Medical Genetics · 349d
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