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
HF-Etchant Hydrofluoric Acid Etching Gel
Rizhao Huge Biomaterials Company, Ltd.
Disposable Vinyl Examination Gloves
Viet Phu Trade and Import Export Co., Ltd.
Cannulated Screws
Maxxion Medical, LLC
ARCHITECT iGentamicin
Abbott Laboratories
Aimanfun Lumea Comfort, A-2789/A-3588
Kam Yuen Plastic Products , Ltd.
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-
Pentax of America, Inc.
PRO-DOSE System
Nu-Rise, SA
Babyroo TN300
Draeger Medical Systems, Inc.
Rapid DeltaFuse
Ischemaview, Inc.
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-
Philips Medizin Systeme Boeblingen GmbH
Plum Duo Precision IV Pump
Icu Medical, Inc.
Syngo Dynamics (Version VA40F)
Siemens Medical Solutions USA, Inc.
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
Gynesonics, Inc.
Disposable Endoscopy Valve Set
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Gepotidacin GEP 10 µg
Liofilchem, Inc.
Green Card Bowie-Dick Test (BD115)
Steritec Products, Inc. (A Getinge Company)
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
Gold Standard Diagnostics, LLC
RadiForce MX317W-PA
Eizo Corporation
PlumeSafe X5 Smoke Management System
Conmed Corporation
IB3D PL Spinal System
Medicrea International S.A.S. (Medtronic)
BIOFIRE SPOTFIRE Respiratory (R) Panel
Biofire Diagnostics
Revital-Ox PAA High Level Disinfectant Chemical Indicator
STERIS Corporation
NEST-C Interbody System
Paonan Biotech Co., Ltd.
Visera Hysterovideoscope Olympus HYF Type V
Olympus Medical Systems Corporation
Legend X Platform
Pollogen, Ltd.
Acute QC Strut and Components
Smith & Nephew, Inc.
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No.
Abbott Molecular, Inc.
airVata
Gelb Practice Solutions, Inc.
XERF
Lutronic Corporation
Atlas Spine Project X Expandable Posterior Lumbar Interbody System
Atlas Spine, Inc.
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