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
1753–1776 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 22, 2026
IPDmilled Blanks
K253253 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 115d
Cleared Jan 22, 2026
AI-Rad Companion Brain MR
K253057 · QIH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jan 22, 2026
Perin Health System (PHD80060-2)
K252984 · DRG
Perin Health Devices, LLC
Cardiovascular · 126d
Cleared Jan 22, 2026
OLYMPIC Posterior Spinal Fixation System
K252885 · PML
Astura Medical
Orthopedic · 134d
Cleared Jan 22, 2026
SMR Shoulder System
K252352 · PHX
Lima Corporate S.P.A.
Orthopedic · 177d
Cleared Jan 22, 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · FLE
Maquet GmbH (A Getinge Group Company)
General Hospital · 182d
Cleared Jan 22, 2026
PhenoMATRIX
K251511 · PPU
Copan Wasp Srl
Microbiology · 251d
Cleared Jan 22, 2026
Device 104 Particulate
K251323 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 268d
Cleared Jan 21, 2026
LumiCera
K260170 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Jan 21, 2026
Infinity™ OCT System
K254165 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jan 21, 2026
RoVo Mechanical Thrombectomy System
K253730 · QEW
Verge Medical, Inc.
Cardiovascular · 58d
Cleared Jan 21, 2026
Arthrex Variable Angle (VA) Proximal Tibia Plating System
K253713 · HRS
Arthrex, Inc.
Orthopedic · 58d
Cleared Jan 21, 2026
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · IYE
Varian Medical Systems, Inc.
Radiology · 126d
Cleared Jan 21, 2026
Boston Pico755
K252369 · GEX
Boston Aesthetics, Inc.
General & Plastic Surgery · 175d
Cleared Jan 21, 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 261d
Cleared Jan 21, 2026
Affirm 400
K251286 · QFX
Digital Surgery Systems, Inc. (D.B.A...
Neurology · 271d
Cleared Jan 21, 2026
Nova Max Creat eGFR Monitoring System
K251281 · SHB
Nova Biomedical Corporation
Chemistry · 272d
Cleared Jan 20, 2026
Clearview Intracoronary Shunts
K253998 · DWF
Medtronic, Inc.
Cardiovascular · 39d
Cleared Jan 20, 2026
Milex™ Incontinence Dish Pessaries
K253698 · HHW
Cooper Surgical
Obstetrics & Gynecology · 57d
Cleared Jan 20, 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K253597 · IYN
Canon Medical Systems Corporation
Radiology · 63d
Cleared Jan 20, 2026
Excelsior System
K253291 · KTT
Blue Ocean Global
Orthopedic · 113d
Cleared Jan 20, 2026
uCT 780 with uWS-CT-Dual Energy Analysis
K253173 · JAK
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Jan 20, 2026
Rusch SoftSimplastic Foley Catheters
K252537 · EZL
Teleflex Medical Sdn. Bhd.
Gastroenterology & Urology · 161d
Cleared Jan 20, 2026
Cholangioscope Visualization System (Single-use Video Cholangioscope:...
K251338 · FBN
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology · 265d