Search FDA 510(k) Devices

5,501 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
2497–2520 of 3,129
Cleared Mar 22, 2024
syngo.CT Brain Hemorrhage
K232431 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 224d
Cleared Mar 22, 2024
Vios Monitoring System(TM) Model 2050
K232354 · DRT
Murata Vios, Inc.
Cardiovascular · 228d
Cleared Mar 22, 2024
MAGNETOM Terra
K232322 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 232d
Cleared Mar 22, 2024
aprevo® anterior and lateral lumbar interbody fusion device, aprevo®...
K232282 · MAX
Carlsmed, Inc.
Orthopedic · 235d
Cleared Mar 22, 2024
FITBONE® Transport and Lengthening System
K232169 · HSB
Orthofix Srl
Orthopedic · 245d
Cleared Mar 22, 2024
Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600...
K232067 · ODC
Medivators (A Subsidiary of Steris...
Gastroenterology & Urology · 255d
Cleared Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
K231953 · FRO
Coloplast Corp.
General & Plastic Surgery · 266d
Cleared Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential,...
K231938 · LZA
O&M Halyard, Inc.
General Hospital · 266d
Cleared Mar 22, 2024
Digital Ultrasonic Diagnostic Imaging System (Model: F6)
K231930 · IYN
Guangdong Youkey Medical Co., Ltd.
Radiology · 266d
Cleared Mar 22, 2024
Elecsys PTH , Elecsys PTH STAT
K231927 · CEW
Roche Diagnostics
Chemistry · 266d
Cleared Mar 22, 2024
NeuroStar Advanced Therapy System (All previously cleared models)
K231926 · OBP
Neuronetics, Inc.
Neurology · 266d
Cleared Mar 22, 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 276d
Cleared Mar 22, 2024
QuickVue COVID-19 Test
K231795 · QYT
Quidel Corporation
Microbiology · 276d
Not Cleared Mar 22, 2024
X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with...
DEN230034 · SAL
Scopio Labs , Ltd.
Hematology · 329d
Cleared Mar 21, 2024
N2
K240754 · EIA
Megagen Implant Co., Ltd.
Dental · 1d
Cleared Mar 21, 2024
DynaNail Mini Tapered Hybrid
K240530 · HWC
MedShape, Inc.
Orthopedic · 27d
Cleared Mar 21, 2024
Tandem Mobi insulin pump with interoperable technology
K240309 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 48d
Cleared Mar 21, 2024
Reach Needle
K240253 · BSP
Aerin Medical, Inc.
Anesthesiology · 51d
Cleared Mar 21, 2024
Medical Diode Laser (Model: L2)
K240179 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Mar 21, 2024
Normatec Elite
K240122 · IRP
NormaTec Industries, LP
Physical Medicine · 65d
Cleared Mar 21, 2024
RedDrop ONE (One)
K234081 · FMK
Reddrop DX
General & Plastic Surgery · 90d
Cleared Mar 21, 2024
APTUS Hand Scaphoid Plates
K234062 · HRS
Medartis AG
Orthopedic · 90d
Cleared Mar 21, 2024
AllSource Drug Detector FenTest
K234006 · NGL
Allsource Screening Solutions
Toxicology · 93d
Cleared Mar 21, 2024
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb...
K233980 · KRO
Depuy Ireland UC
Orthopedic · 94d