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
ClearRead Xray Pneumothorax
Riverain Technologies, Inc.
Heel Incision Safety Lancet
SteriLance Medical (Suzhou), Inc.
Nextra CH Cannulated Hammertoe System
Nextremity Solutions, Inc.
FibroScan 230
Echosens
Otoport Pro
Otodynamics, Ltd.
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, A
Prevest Denpro Limited
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
Perfect Medical Industry (Vn) Co., Ltd.
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
Suzhou Endophix Co., Ltd.
ENSO (Model 2)
Hinge Health, Inc.
HyperLight Portable X-ray Unit
Changzhou Sifary Medical Technology Co., Ltd.
Opulus Lymphoma Precision
Roche Molecular Systems, Inc.
TumorSight Viz
SimBioSys, Inc.
Silver Fluoride Hypersensitivity Varnish
Young Dental Manufacturing Co. 1, LLC
Dexcom G7 Continuous Glucose Monitoring (CGM) System
Dexcom, Inc.
Aevumed FENIX Suture Anchor
Aevumed, Inc.
Adin Long Dental Implant System
Adin Dental Implant Systems , Ltd.
Rapid DeltaFuse
Ischemaview, Inc.
Femoral Trochanteric Nail System Neonail
Neoortho Produtos Ortopédicos S/A
Solea
Convergent Dental, Inc.
Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
Shenzhen Mlay Intelligent Technology Co., , Ltd.
CO2 Laser Treatment Machine (CFR3M1)
Haidari Beauty Technology (Beijing) Co., Ltd.
ZAFIRA®
New Stetic, SA
MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
Asg Superconductors S.P.A.
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
Jingzhou Haixin Green Cross Medical Products Co., Ltd.
PnueAira (PNCU-01)
Biotab, LLC
IPL Home Use Hair Removal Device
Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.
ClotTriever XL Catheter (41-102)
Inari Medical, Inc.
Oclet TDS 1000
Tendonova Corporation
Overjet Caries Assist
Overjet, Inc.
Portable Dental X-ray Device (GT-1)
Guilin Refine Medical Instrument Co., Ltd.
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