Search FDA 510(k) Devices

5,431 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1345–1368 of 174,061
Cleared Oct 22, 2025
Mandibular Advancement Device L07
K251628 · LRK
Dcstar, Inc.
Dental · 147d
Cleared Oct 22, 2025
WELLlife COVID-19 Antigen Test Rx
K251289 · QVF
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 180d
Cleared Oct 22, 2025
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018,...
K251185 · QEW
Intervene
Cardiovascular · 189d
Cleared Oct 22, 2025
Sirona Advanced Imaging Suite
K251030 · LLZ
Sirona Medical
Radiology · 202d
Cleared Oct 22, 2025
XC11 ICE System, USA
K250955 · OBJ
Yorlabs, Inc.
Cardiovascular · 205d
Cleared Oct 22, 2025
Alegria Flash CTD Screen
K250666 · LLL
Zeus Scientific
Immunology · 231d
Cleared Oct 21, 2025
TriALTIS™ Spine System
K253249 · NKB
Medos International SARL
Orthopedic · 22d
Cleared Oct 21, 2025
Aevumed FASE Suture Anchor
K253040 · MBI
Aevumed, Inc.
Orthopedic · 29d
Cleared Oct 21, 2025
HemoSphere Stream Module
K253034 · DQK
Edwards Lifesciences
Cardiovascular · 29d
Cleared Oct 21, 2025
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
K253033 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 29d
Cleared Oct 21, 2025
OLYMPIC Posterior Spinal Fixation System
K252346 · NKB
Astura Medical
Orthopedic · 85d
Cleared Oct 21, 2025
Introducer Sheath Set
K251838 · DYB
Cardiocycle Medical(Suzhou) Co., Ltd.
Cardiovascular · 127d
Cleared Oct 21, 2025
Neuromuscular Transmission Monitor TOF3D (2510091)
K250887 · KOI
MIPM Mammendorfer Institut f?r Physik...
Anesthesiology · 210d
Cleared Oct 21, 2025
Disposable Balloon Catheter (B5-2Q)
K250409 · FGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 250d
Cleared Oct 21, 2025
Fine TTO™
K250394 · PBF
Bodycad Laboratories, Inc.
Orthopedic · 251d
Cleared Oct 21, 2025
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
K250126 · GEI
Livsmed, Inc.
General & Plastic Surgery · 277d
Cleared Oct 21, 2025
NeuroAlign software
K231897 · HAW
Medivis, Inc.
Neurology · 846d
Cleared Oct 20, 2025
InkSpace Imaging Small Body Array (SBA12PH30x)
K253182 · MOS
Inkspace Imaging, Inc.
Radiology · 24d
Cleared Oct 20, 2025
brAIn™ Shoulder Positioning
K252665 · QIH
Avatar Medical
Radiology · 56d
Cleared Oct 20, 2025
VereSee Optical Veres Needle and Endoscopic Camera
K252640 · GCJ
Freyja Healthcare, LLC
General & Plastic Surgery · 60d
Cleared Oct 20, 2025
Q-Switched Nd: YAG Laser machine (LFS-C13U)
K252319 · GEX
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 87d
Cleared Oct 20, 2025
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
K252277 · DSY
Vascular Flow Technologies Limited
Cardiovascular · 90d
Cleared Oct 20, 2025
AVAVA™ Skin Treatment System
K252155 · ONG
Avava, Inc.
General & Plastic Surgery · 103d
Cleared Oct 20, 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
K251414 · NEW
Feeltech Co., Ltd.
General & Plastic Surgery · 166d