Search FDA 510(k) Devices

5,386 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
289–312 of 3,225
Cleared Dec 01, 2025
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08)
K251691 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 182d
Cleared Dec 01, 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · KPS
Canon Medical Systems Corporation
Radiology · 213d
Cleared Dec 01, 2025
Equinoxe® Humeral Reconstruction Prosthesis
K250713 · KWT
Exactech, Inc.
Orthopedic · 266d
Cleared Nov 28, 2025
Dendrite Imaging System
K253303 · QDG
Dendrite Imaging, Inc.
General & Plastic Surgery · 60d
Cleared Nov 28, 2025
Medical Diode Laser Systems (TR-B)
K252658 · GEX
Baoding Te'Anzhou Electronic...
General & Plastic Surgery · 98d
Cleared Nov 28, 2025
CT VScore+
K252217 · JAK
Canon Medical Informatics, Inc.
Radiology · 136d
Cleared Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
K250636 · JXG
Sophysa
Neurology · 270d
Cleared Nov 27, 2025
Carriere® Motion Pro® Clear Bite Corrector
K252760 · DYW
Ortho Organizers, Inc.
Dental · 90d
Cleared Nov 26, 2025
OEC One CFD
K253269 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 58d
Cleared Nov 26, 2025
0.014” Willow Guidewire
K253168 · MOF
Arbor Endovascular, LLC
Neurology · 61d
Cleared Nov 26, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional...
K252405 · NLH
Surgical Instrument Service and...
Cardiovascular · 118d
Cleared Nov 26, 2025
Vanquish Water Vapor Ablation Device
K252388 · KNS
Francis Medical, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 26, 2025
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
K252355 · PTI
Sb-Kawasumi Laboratories, Inc.
General Hospital · 120d
Cleared Nov 26, 2025
RELIEEV HSG Catheter (HSG7FA1)
K252260 · LKF
Li Medical Corporation , Ltd.
Obstetrics & Gynecology · 128d
Cleared Nov 26, 2025
CEREC Tessera Abutment System
K252248 · NHA
Dentsply Sirona
Dental · 131d
Cleared Nov 26, 2025
uDR Arria & uDR Aris
K252000 · KPR
Shanghai United Imaging Healthcare...
Radiology · 152d
Cleared Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
K251697 · GTY
ACON Laboratories, Inc.
Microbiology · 177d
Cleared Nov 26, 2025
Fenom Flo™ FeNO Monitoring System
K251674 · MXA
Mgc Diagnostics Corporation
Chemistry · 180d
Cleared Nov 26, 2025
Tru Kidney Health Test Panel
K251058 · CGX
Truvian Health
Chemistry · 236d
Cleared Nov 26, 2025
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport...
K242976 · JSM
Medical Wire & Equipment Company...
Microbiology · 426d
Not Cleared Nov 26, 2025
MuReva OM™
DEN240077 · SGQ
Mureva Phototherapy, Inc.
Dental · 338d
Cleared Nov 25, 2025
LuxCreo Flexible Partial Denture Resin
K253365 · EBI
LuxCreo, Inc.
Dental · 56d
Cleared Nov 25, 2025
BELLUS-Q
K253344 · GEX
Speclipse, Inc.
General & Plastic Surgery · 56d
Cleared Nov 25, 2025
7600 Ultrasound System (MyLabC25)
K253310 · IYN
Esaote, S.P.A.
Radiology · 57d