510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Hilzo Esophageal Stents
Thoracent, Inc.
KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
Karl Storz SE & CO. KG
Evoblock, Perléon
Evoden Indústria Comércio Importação E Exportação
WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
Boston Scientific
HYDRASHIFT 2/4 isatuximab
Sebia
da Vinci E-200 Electrosurgical Generator
Intuitive Surgical
SpyGlass Discover Balloon Dilation Catheter
Boston Scientific Corporation
nordicAudio (1.0)
Nordicneurolab AS
Neodent Implant System - Custom Abutments
Jjgc Indústria E Comércia DE Materiais Dentários S.A.
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Ge Medical Systems Information Technologies, Inc.
TRAUS ENDO
Saeshin Precision Co., Ltd.
OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
OSSIO , Ltd.
DeepCatch
Medical IP Co., Ltd.
Mimics Cardiac Planner
Materialise NV
Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposab
SteriLance Medical (Suzhou), Inc.
MOTUS PRO Family
El.En S.P.A.
The Botticelli (Model: Athena)
Bellamia Technologies, Inc.
Blood Volume Analyzer (200)
Daxor Corporation
Logical Liner; World Liner; World Knee Patella
Signature Orthopaedics Pty, Ltd.
Core Metabolic
Truvian Health
ABPMpro
Somnomedics GmbH
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
Ammex Corporation
LIAISON PLEX Yeast Blood Culture Assay
Luminex Corporation
Ultrasonic Surgical & Electrosurgical Generator
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Delphi Stimulator
Quantalx Neuroscience
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
Conformis, Inc.
Denti.AI Detect
Denti.Ai Technology, Inc.
da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc.
Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
Us Medical Innovations, LLC
Hoffmann LRF System
Stryker GmbH
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