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
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc.
ZBPro Diagnostic
Zbeats, Inc.
TrabEx Pro
Microsurgical Technologies, Inc.
Parsortix PC1 Device
Angle Europe , Ltd.
s-Clean Pre-Milled Abutment Mini
Dentis Co., Ltd.
eMurmur Heart AI
Csd Labs GmbH
ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); R
Microline Surgical, Inc.
Nurochek-II System
Headsafe Mfg Pty, Ltd.
PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diff
Ganshorn Medizin Electronic GmbH
Bard 3DMax Mesh
Davol Inc., Subsidiary of C. R. Bard, Inc.
GEMS-H
Samsung Electronics Co., Ltd.
Sil-Flow
Dsi Dental Solutions, Ltd.
Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
Fissiontech, LLC
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3
Philips Image Guided Therapy Corporation
LifeShield Infusion Safety Software Suite
Icu Medical, Inc.
V-PVP
Vitromed GmbH
restor3d Reverse Total Shoulder Arthroplasty System
Restor3D
Allix5
Clairity, Inc.
Power Wheelchair (W5915B, W5915C, W5915D)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
CCI PACS VIEWER (PACS-US-001)
CliniComp, Intl.
Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube
Cooper Surgical
Arthrex SoftStitch
Arthrex, Inc.
Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
Borvo Medical, Inc.
Altaviz Intravitreal Syringe
Altaviz, LLC
Disposable IV catheter
Shinva Ande Healthcare Apparatus Co., Ltd.
Aquilo Sports CCT1500 System
Aquilo Sports, LLC
FIREFLY® Cervical Navigation Guide
Mighty Oak Medical, Inc.
EmbraceMini
Empatica S.r.l.
Safety Blood Collection Needles with/without Needle Holder
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
Capenergy Medical S.L.
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