Search FDA 510(k) Devices

5,430 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
1009–1032 of 3,225
Cleared Sep 08, 2025
Coaptium Connect with Tissium Light
K251957 · SFD
Tissium SA
Neurology · 75d
Cleared Sep 08, 2025
BioTraceIO Vision (V1.7)
K251931 · QTZ
Techsomed Medical Technologies
Radiology · 76d
Cleared Sep 08, 2025
MAXXOS P.A.C.E. Foot & Ankle Plating System
K251892 · HRS
Maxxos Medical GmbH
Orthopedic · 80d
Cleared Sep 08, 2025
Wearable Breast Pump (Model S33)
K251754 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Sep 08, 2025
qER-CTA (v1.0)
K251610 · QAS
Qure.Ai Technologies
Radiology · 104d
Cleared Sep 08, 2025
Momcozy Wearable Breast Pump (BP223)
K251394 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 126d
Cleared Sep 08, 2025
da Vinci Surgical System (IS5000)
K251227 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared Sep 08, 2025
DUO Microcatheter
K250960 · QJP
Rev Neuro, LLC
Neurology · 161d
Cleared Sep 08, 2025
OmniTom Elite with PCD
K250928 · JAK
Neurologica Corporation
Radiology · 164d
Cleared Sep 08, 2025
Dual Action Tissue Closure Device
K250229 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 224d
Cleared Sep 05, 2025
Ion Endoluminal System (IF1000)
K252528 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 05, 2025
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478 · LJT
Bard Access Systems, Inc.
General Hospital · 29d
Cleared Sep 05, 2025
GenaCheck COVID-19 Rapid Self-Test
K251753 · QYT
Genabio Diagnostics, Inc.
Microbiology · 88d
Cleared Sep 05, 2025
SOLOPASS 2.0 System
K251317 · HAW
Intravent Medical Partners
Neurology · 129d
Cleared Sep 05, 2025
ViewMate™ Multi Ultrasound System (VMM-ICE-01)
K251250 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 135d
Cleared Sep 05, 2025
3D-SHAPER
K251022 · KGI
3D-Shaper Medical S.L
Radiology · 156d
Cleared Sep 05, 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K250575 · JWY
Thermo Fisher Scientific
Microbiology · 191d
Cleared Sep 05, 2025
WatchPAT400 (WP400)
K250460 · MNR
Itamar Medical , Ltd.
Anesthesiology · 199d
Cleared Sep 05, 2025
Ureteral Access Sheath
K250132 · FED
Zhejiang Yigao Medical Technology...
Gastroenterology & Urology · 231d
Cleared Sep 05, 2025
All-Suture Dual Anchor System
K250095 · MBI
Suturetech, Inc.
Orthopedic · 234d
Cleared Sep 05, 2025
High Pressure Tubing
K244038 · DXT
Shandong Int Medical Instruments Co.,...
General Hospital · 249d
Cleared Sep 05, 2025
pREBOA-PRO Catheter
K243795 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 269d
Cleared Sep 04, 2025
KALA MINI 2.0 (KALA-04)
K251781 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 85d
Cleared Sep 04, 2025
NextAR(TM) Shoulder Platform
K251737 · SBF
Medacta International S.A.
Orthopedic · 90d