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
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
Prosomnus Sleep Technologies
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Embrace Vision Neonatal MRI System
Aspect Imaging, Ltd.
Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technology Co., Ltd.
Volta AF-Xplorer
Volta Medical
uCerv Flux-C 3D Porous Titanium Cervical Interbody
Ulrich Medical USA, Inc.
Straumann® BLC and TLC Implants
Institut Straumann AG
1.5T 24E Posterior Array
Shenzhen RF Tech Co., Ltd.
Derma-Gide
Geistlich Pharma AG
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Anhui Powerguard Technology Co., Ltd.
Navigation Tracking Instruments
SI-BONE, Inc.
Cornisol
Aurolab
CINtec Histology
Ventana Medical Systems, Inc.
Stelo Glucose Biosensor System
Dexcom, Inc.
Plasma IQ
Neauvia North America, Inc.
RelieVRx (Pico G3)
Appliedvr
REMI AI Discrete Detection Module
Epitel, Inc.
Verruca-Freeze® H
Cryosurgery, Inc.
Vericor Support Catheter
Vascupatent Medical (Shenzhen) Co., Ltd.
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
Meditrina, Inc.
Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endoveno
Acotec Scientific Co., Ltd.
EzVu Visual Vasopressor injector (EV-19)
Veol Medical Technologies Pvt , Ltd.
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSL
Ethicon Endo-Surgery, LLC
Ear Thermometer, Model ET005, ET008, ET009
Guangzhou Berrcom Medical Device Co., Ltd.
Dynamic TiBase
Talladium Espana, SL
inVisionOS
Precisionos Technology, Inc.
GLOBAL ICON Stemless Shoulder System
Depuy(Ireland)
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Othe
Lingshi Hongruida Health Protection Technology Co., Ltd.
Motiva Flora SmoothSilk Tissue Expander
Motiva USA, LLC
The Oligio
Wontech Co., Ltd.
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