Search FDA 510(k) Devices

5,552 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
2977–3000 of 3,225
Cleared Jan 31, 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K242966 · DQO
Gentuity, LLC
Cardiovascular · 127d
Cleared Jan 31, 2025
Mobility Scooter (MS160A)
K242982 · INI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 127d
Cleared Jan 31, 2025
Nuance Audio Hearing Aid Software
K243150 · SCR
Luxottica Group S.P.A.
Ear, Nose, Throat · 123d
Cleared Jan 31, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243441 · LZA
Basic Medical Technology, Inc.
General Hospital · 86d
Cleared Jan 31, 2025
Game Ready system (550500-04)
K243572 · IRP
Avanos Medical, Inc.
Physical Medicine · 74d
Cleared Jan 31, 2025
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
K243665 · MBI
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 65d
Cleared Jan 31, 2025
Arthrex DynaNite Nitinol Staples
K243742 · JDR
Arthrex, Inc.
Orthopedic · 58d
Cleared Jan 31, 2025
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s...
K243820 · FED
Dornier Medtech America
Gastroenterology & Urology · 50d
Cleared Jan 30, 2025
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
K233956 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 412d
Cleared Jan 30, 2025
BTL-754
K241270 · GEX
BTL Industries, Inc.
General & Plastic Surgery · 269d
Cleared Jan 30, 2025
MyShoulder Planner (5.3SSWPL)
K241292 · KWS
Medacta International S.A.
Orthopedic · 267d
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d
Cleared Jan 30, 2025
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K242717 · BTT
Laboratorios Biogalenic S.A. DE C.V.
Anesthesiology · 142d
Cleared Jan 30, 2025
Rotarex Atherectomy System
K242757 · MCW
Bard Peripheral Vascular, Inc.
Cardiovascular · 140d
Cleared Jan 30, 2025
Ureteral Access Sheath
K243025 · FED
Seplou (Zhuhai) Co., Ltd.
Gastroenterology & Urology · 125d
Cleared Jan 30, 2025
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · NBW
Guangdong Transtek Medical...
Chemistry · 125d
Cleared Jan 30, 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · JWY
Liofilchem S. R. L.
Microbiology · 121d
Cleared Jan 30, 2025
simpli-COLLECT STI Test
K243410 · QYA
Abbott Molecular
Microbiology · 90d
Cleared Jan 30, 2025
iBOT® PMD
K243442 · IMK
Mobius Mobility
Physical Medicine · 85d
Cleared Jan 30, 2025
WasherCap™ Mini Fixation System (Model 45)
K243712 · MBI
Abanza Tecnomed S.L
Orthopedic · 59d
Cleared Jan 30, 2025
Osprey Suture Anchor
K243726 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 58d
Cleared Jan 29, 2025
CareSuperb™ COVID-19 Antigen Home Test
K241915 · QYT
Access Bio, Inc.
Microbiology · 212d
Cleared Jan 29, 2025
Surcam Dental Implant System
K242217 · DZE
Surcam Medical Devices and...
Dental · 184d
Cleared Jan 29, 2025
Co-Ablation System with Sterile Co-Ablation Probe
K243042 · GEH
Hygea Medical Technology Co., Ltd.
General & Plastic Surgery · 124d