FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
769–792 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 13, 2026
InSet Reverse Total Shoulder System
K254128 · PHX
Shoulder Innovations, Inc.
Orthopedic · 112d
Cleared Apr 13, 2026
HVT 2.0
K254078 · BTT
Vapotherm, Inc.
Anesthesiology · 116d
Cleared Apr 13, 2026
ACORYS MAPPING SYSTEM
K253861 · DQK
Corify Care S.L
Cardiovascular · 131d
Cleared Apr 13, 2026
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings,...
K253592 · MBF
Zimmer, Inc.
Orthopedic · 147d
Cleared Apr 13, 2026
b-ONE® Bipolar Head
K253357 · KWY
B-One Ortho, Corp.
Orthopedic · 195d
Cleared Apr 13, 2026
Elecsys Anti-SARS-CoV-2 S
K252280 · QVP
Roche Diagnostics
Microbiology · 265d
Cleared Apr 10, 2026
Protaryx Transseptal Puncture Device (PTX2-001)
K260839 · DYB
Protaryx Medical, Inc.
Cardiovascular · 28d
Cleared Apr 10, 2026
LOBO Vascular Occlusion System
K260508 · KRD
Okami Medical, Inc.
Cardiovascular · 52d
Cleared Apr 10, 2026
Porcelain Etch Gel
K260430 · KLE
Belport Company, Inc., Gingi-Pak
Dental · 59d
Cleared Apr 10, 2026
Auryon Atherectomy System
K260244 · MCW
Eximo Medical
Cardiovascular · 73d
Cleared Apr 10, 2026
SMART Osteotomy System
K260090 · HRS
Actis Medical Pty., Ltd.
Orthopedic · 88d
Cleared Apr 10, 2026
TRIOS Dx (R1)
K260082 · SHQ
3Shape TRIOS A/S
Dental · 88d
Cleared Apr 10, 2026
VRNT
K254004 · QRA
Cognifisense, Inc.
Physical Medicine · 116d
Cleared Apr 10, 2026
Overjet Iris Intelligent Imaging System
K253930 · QIH
Overjet, Inc.
Radiology · 122d
Cleared Apr 10, 2026
Diacore
K253926 · NGX
ShenB Co., Ltd.
Physical Medicine · 123d
Cleared Apr 10, 2026
ARION ARC System
K253917 · GEI
Plasma Surgical, Inc.
General & Plastic Surgery · 123d
Cleared Apr 10, 2026
Ascblue (8010)
K253777 · GEI
Ascblue Corporation
General & Plastic Surgery · 135d
Cleared Apr 10, 2026
syngo Dynamics (VA41F)
K253689 · QIH
Siemens Healthcare GmbH
Radiology · 140d
Cleared Apr 10, 2026
Tri-staple 2.0™ Reloads
K253657 · GDW
Covidien (Part of Medtronic)
General & Plastic Surgery · 141d
Cleared Apr 10, 2026
Freestyle Mini Hands-free
K253510 · HGX
Medela, LLC
Obstetrics & Gynecology · 156d
Cleared Apr 10, 2026
AeroDR TX c02
K253446 · KPR
Dk Medical Systems Co., Ltd.
Radiology · 190d
Cleared Apr 10, 2026
Teleport Glide Microcatheter
K253361 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 192d
Cleared Apr 10, 2026
ShaeferH
K252942 · LRK
Shaeferh, LLC
Dental · 207d
Cleared Apr 10, 2026
CeQur Simplicity™ On-Demand Insulin Delivery System
K252757 · OPP
Cequr SA
Chemistry · 224d