Search FDA 510(k) Devices

5,464 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1873–1896 of 174,061
Cleared Aug 22, 2025
CPS Locator 3D Delivery Catheter
K250147 · DQY
Centerpoint Systems
Cardiovascular · 213d
Cleared Aug 22, 2025
EnDrive (EnDriveUS)
K243692 · EKX
Advanced Technology Research (A.T.R.)...
Dental · 266d
Cleared Aug 22, 2025
MammoScreen BD
K243685 · QIH
Therapixel
Radiology · 266d
Cleared Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660 · FMF
Cardinalhealth
General Hospital · 268d
Cleared Aug 21, 2025
The Acumed Wrist Fixation System - 2.4mm Screws
K252356 · HRS
Acumed, LLC
Orthopedic · 23d
Cleared Aug 21, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K252244 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 34d
Cleared Aug 21, 2025
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS...
K251647 · DZE
Dentsply Sirona, Inc.
Dental · 84d
Cleared Aug 21, 2025
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
K251588 · OHS
Shenzhen Fittop Health Technology...
General & Plastic Surgery · 90d
Cleared Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Aug 21, 2025
Treace Medical Concepts (TMC) Implant Fixation System
K251135 · HRS
Treace Medical Concepts
Orthopedic · 129d
Cleared Aug 21, 2025
Portable Oxygen Concentrator (JM-P50A)
K251130 · CAW
Jiangsu Jumao X-Care Medical...
Anesthesiology · 132d
Cleared Aug 21, 2025
Vista OS, Vista AI Scan, RTHawk
K251029 · LNH
Vista AI, Inc.
Radiology · 141d
Cleared Aug 21, 2025
ClearTip FNA and FNB Types
K250994 · FCG
Finemedix Co., Ltd.
Gastroenterology & Urology · 142d
Cleared Aug 21, 2025
Fine Osteotomy™
K250923 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 147d
Cleared Aug 21, 2025
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/...
K250784 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 160d
Cleared Aug 21, 2025
Origin™
K243965 · SFO
Nerv Technology Inc. (D.B.A.) Fluidai...
Chemistry · 241d
Cleared Aug 21, 2025
InSee
K241152 · BWF
Tidal Medical Technologies, LLC
Anesthesiology · 482d
Cleared Aug 20, 2025
T1D1
K252104 · NDC
Comerge AG
Chemistry · 48d
Cleared Aug 20, 2025
Distal Xtremities System
K252061 · HRS
TriMed, Inc.
Orthopedic · 50d
Cleared Aug 20, 2025
Salix Coronary Plaque (V1.0.0)
K251837 · QIH
Artrya Limited
Radiology · 65d
Cleared Aug 20, 2025
Methinks CTA Stroke
K251590 · QAS
Methinks Software, S.L
Radiology · 89d
Cleared Aug 20, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
K251580 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Aug 20, 2025
WELLlife Flu A&B Home Test
K251563 · SCA
Wondfo USA Co., Ltd.
Microbiology · 90d
Cleared Aug 20, 2025
ACUSON Sequoia Diagnostic Ultrasound System
K251481 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 99d