Search FDA 510(k) Devices

5,462 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
1465–1488 of 3,225
Cleared Jul 15, 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · LCX
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 102d
Cleared Jul 15, 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 103d
Cleared Jul 15, 2025
Thrive 2-in-1 Breast Pump (Model P3)
K250350 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 158d
Cleared Jul 15, 2025
AV Viewer
K250181 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d
Cleared Jul 15, 2025
Tempus ECG-Low EF
K250119 · QYE
Tempus AI, Inc.
Cardiovascular · 180d
Cleared Jul 15, 2025
IsoSphere
K242818 · KXK
Isoaid, LLC
Radiology · 300d
Cleared Jul 15, 2025
Jewel Soft Tissue Reinforcement Device (102-6005)
K242237 · QUW
Xiros Limited
Orthopedic · 350d
Cleared Jul 14, 2025
Phantom® Hindfoot TTC/TC Nail System
K251850 · HSB
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 14, 2025
Materialise TKA Guide System
K251554 · JWH
Materialise NV
Orthopedic · 54d
Cleared Jul 14, 2025
FLOWRUNNER Aspiration System
K251488 · QEZ
Expanse Medical, Inc.
Cardiovascular · 61d
Cleared Jul 14, 2025
CoolTone
K251378 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 73d
Cleared Jul 14, 2025
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD,...
K251173 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 89d
Cleared Jul 14, 2025
The Acumed Wrist Fixation System - Plates
K251132 · HRS
Acumed, LLC
Orthopedic · 94d
Cleared Jul 14, 2025
PeekMed web
K251096 · QIH
Peek Health, S.A.
Radiology · 95d
Cleared Jul 14, 2025
LUMINOS Q.namix T
K250660 · OWB
Siemens Medical Solutions
Radiology · 131d
Cleared Jul 14, 2025
Leonardo Duster
K250504 · GEX
Ceramoptec GmbH
General & Plastic Surgery · 144d
Cleared Jul 14, 2025
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19,...
K250185 · DXN
Jiangxi Aicare Medical Technology...
Cardiovascular · 173d
Cleared Jul 14, 2025
GECHO
K250120 · LLZ
Narnar, LLC
Radiology · 179d
Cleared Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
K243917 · BZR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Jul 13, 2025
Welch Allyn Connex® 360 (Multiple)
K243598
Welch Allyn, Inc.
Cardiovascular · 234d
Cleared Jul 12, 2025
NightWatch+ US
K243199 · POS
Livassured BV
Neurology · 284d
Cleared Jul 11, 2025
Achieva
K251808 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jul 11, 2025
Geistlich Bio-Oss®
K251786 · NPM
Geistlich Pharma AG
Dental · 30d
Cleared Jul 11, 2025
AEON™ Endoscopic Powered Stapler
K251482 · GAG
Lexington Medical, Inc.
General & Plastic Surgery · 58d