Search FDA 510(k) Devices

5,395 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2026–2026 ×
740 results
433–456 of 740
Cleared Feb 12, 2026
PuraCath Firefly Needleless Connector IT (9005)
K251375 · FPA
Puracath Medical, Inc.
General Hospital · 286d
Cleared Feb 11, 2026
iFuse INTRA Ti™ Implant System
K253488 · OUR
SI-BONE, Inc.
Orthopedic · 110d
Cleared Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K253049 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 142d
Cleared Feb 11, 2026
AXS Lift Intracranial Base Catheter
K253032 · QJP
Stryker Neurovascular
Neurology · 142d
Cleared Feb 11, 2026
AI4CMR v2.0
K252084 · QIH
Ai4medimaging Medical Solutions S.A.
Radiology · 224d
Cleared Feb 11, 2026
ArmSure Fluoroscopic Positioning System
K251992 · OWB
Savfe Co. , Ltd.
Radiology · 229d
Cleared Feb 11, 2026
CURIS II RF Generator (REF 360100-05)
K251813 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 243d
Cleared Feb 11, 2026
SteriHub™ Disinfecting Device and Protective Cover
K251592 · QBP
1World Vista Medical
General Hospital · 264d
Not Cleared Feb 11, 2026
Delivery Date AI
DEN250007 · SHE
Ultrasound AI
Radiology · 331d
Cleared Feb 10, 2026
SpaceOAR Vue System (SV-2101)
K260119 · OVB
Boston Scientific Corporation
Radiology · 27d
Cleared Feb 10, 2026
XT3 System
K260073 · JDW
Biodynamik, Inc.
Orthopedic · 32d
Cleared Feb 10, 2026
MI View&GO
K254016 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Feb 10, 2026
Vulcan Spinal System
K253545 · NKB
K2m, Inc.
Orthopedic · 88d
Cleared Feb 10, 2026
CollOvine™ Wound Powder
K253140 · KGN
Ovigenex, LLC
General & Plastic Surgery · 138d
Cleared Feb 10, 2026
Earflo (EF001)
K252751 · MJV
Earflo, Inc.
Ear, Nose, Throat · 165d
Cleared Feb 10, 2026
multiFlux 130 (F00013123)
K252459 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 189d
Cleared Feb 10, 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
K252179 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 214d
Cleared Feb 10, 2026
LANDR Contact LENS Case
K252175 · LRX
Fourth Axis, LLC
Ophthalmic · 214d
Cleared Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 256d
Cleared Feb 10, 2026
Solidex® Ti-Links and Screws
K251515 · NHA
CreoDent Hudson Valley
Dental · 270d
Cleared Feb 09, 2026
Peel-Away Introducer Sheath
K254236 · DYB
VascuTech Medical, LLC
Cardiovascular · 42d
Cleared Feb 09, 2026
Ceribell Instant EEG Headset
K254033 · GXY
Ceribell, Inc.
Neurology · 55d
Cleared Feb 09, 2026
Holter ECG and ABP system (HolterABP)
K251591 · DQK
Edan Instruments, Inc.
Cardiovascular · 262d
Cleared Feb 06, 2026
LiveMedica Enterprise PACS
K253927 · LLZ
Live Medica, LLC
Radiology · 60d