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
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Stryker Corporation
Cold Sore Device (QPZ-03)
Shenzhen Nuon Medical Equipment Co., Ltd.
Aevumed PHANTOM Suture Anchors
Aevumed, Inc.
CPS Locator 3D Plus Delivery Catheter
CenterPoint Systems, LLC
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
Biomérieux
autoSCORE
Holberg Eeg AS
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
Institut Straumann AG
Arthrex FiberTak Suture Anchor
Arthrex, Inc.
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
Abbott Molecular
TrueBalance Surgical System
These Three Medical, LLC
Litho 60; Litho 100; Litho 150
Quanta System Spa
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
OTU Medical, Inc.
Prospera Spectruum Negative Pressure Wound Therapy System
Deroyal Industries, Inc.
Swan-Ganz catheter
Edwards Lifesciences, LLC
Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
Alphatec Spine, Inc.
SCIZER (SC1-M410)
Classys, Inc.
Kem Medical Lead-free Chemical Indicators for Steam Sterilization
Kem Medical Products Corporation
LUOFUCON® Antimicrobial Wound Gel
Huizhou Foryou Medical Co., Ltd.
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
INFINITY OCT System
Medtronic Sofamor Danek USA, Inc.
CaRi-Heart
Caristo Diagnostics , Ltd.
ExactechGPS® Total Ankle Application
Blue Ortho
SKOUT system
Iterative Health
Ultra-Fast Warm
Kitazato Corporation
UNITY DX (UDX)
Cylite Pty. , Ltd.
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ort
Stryker Leibinger GmbH & Co KG
PTFE Guidewire
Lake Region Medical
Intuitive Endoluminal Gastrointestinal System (IG1000)
Intuitive Surgical, Inc.
Aspira Peritoneal Drainage System
Merit Medical Systems, Inc.
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
Origyn Medical Technology (Hangzhou) Co., Ltd.
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