Search FDA 510(k) Devices

5,476 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
2041–2064 of 174,061
Cleared Aug 01, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...
K243458 · LJS
Access Vascular, Inc.
General Hospital · 266d
Cleared Aug 01, 2025
Equinoxe® Shoulder System
K243448 · PHX
Exactech, Inc.
Orthopedic · 267d
Cleared Aug 01, 2025
QuickSleeper 5
K243427 · EGM
Dentalhitec
Dental · 269d
Cleared Jul 31, 2025
Sleep Watch
K251574 · LEL
Ambulatory Monitoring, Inc.
Neurology · 70d
Cleared Jul 31, 2025
Biograph Trinion
K251561 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 71d
Cleared Jul 31, 2025
Wearable Breast Pump (Model FS12A)
K250843 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 133d
Cleared Jul 31, 2025
YSIO X.pree
K250738 · KPR
Siemens Medical Solutions
Radiology · 142d
Cleared Jul 31, 2025
REMEX Xcam6
K250597 · IZL
Remedi, Inc.
Radiology · 153d
Cleared Jul 31, 2025
NextAR(TM) Spine
K250477 · SBF
Medacta International S.A.
Orthopedic · 162d
Cleared Jul 31, 2025
eCO2 3D
K244060 · ONG
Lutronic Corporation
General & Plastic Surgery · 212d
Cleared Jul 31, 2025
U2 Total Knee System – PF+ Patella
K243656 · MBH
United Orthopedic Corporation
Orthopedic · 247d
Cleared Jul 31, 2025
Trabecular Metal Acetabular Revision System, Acetabular Liners and...
K243571 · JDI
Zimmer Biomet
Orthopedic · 255d
Cleared Jul 31, 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
K243455 · QOF
Roche Molecular Systems, Inc.
Microbiology · 266d
Cleared Jul 31, 2025
Genius AI Detection 2.0
K243341 · QDQ
Hologic, Inc.
Radiology · 279d
Cleared Jul 31, 2025
BeneVision Central Monitoring System
K242728 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 324d
Cleared Jul 31, 2025
Mpact Constrained Liner
K241461 · KWZ
Medacta International S.A.
Orthopedic · 434d
Cleared Jul 30, 2025
Iconix Speed Anchor
K252144 · MBI
Riverpoint Medical
Orthopedic · 22d
Cleared Jul 30, 2025
T65 (9016E061-)
K252032 · OBP
Tonica Elektronik A/S
Neurology · 30d
Cleared Jul 30, 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · OVE
Acuity Surgical Devices, LLC
Orthopedic · 54d
Cleared Jul 30, 2025
TENS and EMS Unit
K251706 · NGX
Changsha Anxiang Medical Technology...
Physical Medicine · 57d
Cleared Jul 30, 2025
Tyber Medical Distal Radius Plating System
K251361 · HRS
Tyber Medical, LLC
Orthopedic · 90d
Cleared Jul 30, 2025
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K251319 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jul 30, 2025
EnSite™ X EP System
K251234 · DQK
Abbott Medical
Cardiovascular · 99d
Cleared Jul 30, 2025
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
K251076 · GEX
Shenzhen Lifotronic Technology Co., Ltd.
General & Plastic Surgery · 113d