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: Cleared only ×
174,955 results
2137–2160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2025
MSS - Humeral reverse liners extension
K250338 · PHX
Medacta International S.A.
Orthopedic · 267d
Cleared Oct 31, 2025
Chex-All Sterilization Pouches and Tubes
K250306 · FRG
Propper Manufacturing Co., Inc.
General Hospital · 270d
Cleared Oct 30, 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
K253376 · KRD
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Oct 30, 2025
HANAROSTENT Esophagus Upper (CCC)
K253327 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Oct 30, 2025
ellacor System with Micro-Coring Technology
K252752 · QAI
Cytrellis Biosystems, Inc.
General & Plastic Surgery · 62d
Cleared Oct 30, 2025
AllTest Urinary Tract Infection Test
K252607 · JMT
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 73d
Cleared Oct 30, 2025
Moses™ 200 D/F/L Laser Fiber (M0068130100)
K252529 · GEX
Boston Scientific Corporation
General & Plastic Surgery · 80d
Cleared Oct 30, 2025
Freeprint® denture flex
K252430 · EBI
Detax GmbH
Dental · 90d
Cleared Oct 30, 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 90d
Cleared Oct 30, 2025
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)
K252387 · QOF
Diasorin Molecular, LLC
Microbiology · 91d
Cleared Oct 30, 2025
Zoom System (Zoom 4S Catheter)
K252046 · NRY
Imperative Care, Inc.
Neurology · 122d
Cleared Oct 30, 2025
GEN5 and GEN5+ Dental Implant System
K251938 · DZE
Paragon Implant Mfg., LLC
Dental · 128d
Cleared Oct 30, 2025
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
K251686 · KWT
Tornier, Inc.
Orthopedic · 150d
Cleared Oct 30, 2025
AIR COMPRESSION BOOTS 1018195,1018196
K251531 · IRP
Merchsource, LLC
Physical Medicine · 164d
Cleared Oct 30, 2025
Arctx Cool Catheter Set
K250632 · PLA
Arctx Medical
Cardiovascular · 241d
Cleared Oct 30, 2025
AiORTA - Plan
K250337 · QIH
ViTAA Medical Solutions, Inc.
Radiology · 266d
Cleared Oct 30, 2025
BD Alaris Pump Infusion Set
K250325 · FPA
Carefusion (Bd)
General Hospital · 267d
Cleared Oct 30, 2025
Niti-S Esophageal Stent
K243619 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 342d
Cleared Oct 29, 2025
Difiney Advanced Anti Snoring Device 4.0
K253355 · LRK
Fissiontech, LLC
Dental · 29d
Cleared Oct 29, 2025
JARVIS Diaphyseal Stem Standard
K253345 · PHX
FH Industrie
Orthopedic · 29d
Cleared Oct 29, 2025
Protrieve Sheath
K253323 · QEW
Inari Medical
Cardiovascular · 29d
Cleared Oct 29, 2025
Freedom Infinia™ Total Knee System
K253314 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 29d
Cleared Oct 29, 2025
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-,...
K253283 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 30d
Cleared Oct 29, 2025
LCD Monitor (C1216W, C822W, C821W)
K253242 · PGY
Shenzhen Beacon Display Technology...
Radiology · 30d