Search FDA 510(k) Devices

5,373 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
73–96 of 3,225
Cleared Dec 22, 2025
Oxygen Concentrator-P2-O5E
K251764 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 196d
Cleared Dec 22, 2025
DIMPLO Implant System
K251605 · DZE
DIMPLO, Ltd.
Dental · 209d
Cleared Dec 22, 2025
Power wheelchair
K251159 · ITI
Zhenjiang Assure Medical Equipment...
Physical Medicine · 251d
Cleared Dec 22, 2025
Tetra (TM-20)
K251105 · PKP
Emed Technologies Corporation
General Hospital · 255d
Cleared Dec 22, 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019 · FGE
Bioteque Corporation
Gastroenterology & Urology · 264d
Cleared Dec 22, 2025
BioticsAI
K250959 · IYN
Bioticsai, Inc.
Radiology · 266d
Cleared Dec 22, 2025
Pression Wave PRO External Counter-Pulsation System
K250756 · DRN
Pression, Inc.
Cardiovascular · 285d
Cleared Dec 22, 2025
KP Protective Face Mask
K243342 · FXX
Kp Trading Co., Ltd.
General Hospital · 423d
Cleared Dec 19, 2025
iCEM Universal Plus
K254063 · EMA
Kulzer, LLC
Dental · 2d
Cleared Dec 19, 2025
STAR Apollo™ Mapping System
K253733 · DQK
Rhythm AI, Ltd.
Cardiovascular · 25d
Cleared Dec 19, 2025
ProtekDilate Vascular Access Kit
K253616 · DRE
Sorin Group Italia S.R.L.
Cardiovascular · 31d
Cleared Dec 19, 2025
Monkey Rings External Ring Fixation System
K253613 · KTT
Paragon 28, Inc.
Orthopedic · 31d
Cleared Dec 19, 2025
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
K253577 · MAX
Medicrea International S.A.S....
Orthopedic · 32d
Cleared Dec 19, 2025
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
K253479 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 66d
Cleared Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48),...
K253409 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Dec 19, 2025
Southern Craniomaxillofacial (CMF) System
K253373 · JEY
Southern Medical (Pty) , Ltd.
Dental · 80d
Cleared Dec 19, 2025
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · DFH
Diazyme Laboratories, Inc.
Immunology · 80d
Cleared Dec 19, 2025
Hoffmann LRF System
K253202 · KTT
Stryker GmbH
Orthopedic · 84d
Cleared Dec 19, 2025
Balanced Knee System TriMax Porous Femoral Components
K253161 · MBH
Ortho Development Corp.
Orthopedic · 84d
Cleared Dec 19, 2025
LED Light Therapy Device (Models: SG-FM, SG-FE)
K253086 · OHS
Sunglor Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 19, 2025
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
K253054 · OHS
Shenzhen Xinlong Precision Plastic...
General & Plastic Surgery · 88d
Cleared Dec 19, 2025
EMPOWR Knee
K252974 · JWH
Encore Medical, L.P.
Orthopedic · 93d
Cleared Dec 19, 2025
SCOUT MD Surgical Guidance System
K252892 · NEU
Merit Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Dec 19, 2025
SANDRO Dual
K252877 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 100d