Search FDA 510(k) Devices

5,400 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
505–528 of 3,225
Cleared Oct 31, 2025
Firebird SI Navigation System
K252088 · OLO
Orthofix US, LLC
Orthopedic · 121d
Cleared Oct 31, 2025
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
K252074 · IYN
Canon Medical Systems Corporation
Radiology · 121d
Cleared Oct 31, 2025
GREEN
K252060 · HBE
Phasor Health, LLC
Neurology · 122d
Cleared Oct 31, 2025
DESS Dental Smart Solutions
K251547 · NHA
Terrats Medical SL
Dental · 163d
Cleared Oct 31, 2025
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · GXY
Ceribell, Inc.
Neurology · 182d
Cleared Oct 31, 2025
GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
K251041 · FDS
Actuated Medical, Inc.
Gastroenterology & Urology · 211d
Cleared Oct 31, 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor,...
K250917 · FGB
Shenzhen Sanping Image Technology...
Gastroenterology & Urology · 218d
Cleared Oct 31, 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus...
K250358 · PCI
Becton, Dickinson and Company
Microbiology · 266d
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
Not Cleared Oct 31, 2025
Pulsenmore ES
DEN240074 · SGJ
Pulsenmore, Ltd.
Radiology · 324d
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