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
Halcyon, Ethos Radiotherapy System (5.0)
Varian Medical Systems, Inc.
Sagami Original 002 Polyurethane Male Condom
Mayer Laboratories
LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
DiaSorin, Inc.
Reliance Cervical IBF System
Reliance Medical Systems, LLC
Enbio S
Enbio Group AG
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
Biomet Manufacturing Corp
MCI-Neuro Fixation System
Mci Medical Concept Innovation, Inc.
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
Maine Molecular Quality Controls, Inc.
CIRCUL8 Connect DVT Prevention Device
Ortho8, Inc.
Freeprint® denture flex
Detax GmbH
BIASURGE Advanced Surgical Solution
Rochal Technologies, LLC
Obsidian® Press Over Zirconia
Prismatik Dentalcraft, Inc.
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
Jiangsu Channel Medical Device Co., Ltd.
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
Medtronic, Inc.
SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
Bosungmeditech Co., Ltd.
ReddyPort Elbow
Smd Manufacturing, LLC
Pulse Oximeter
Shanghai Berry Electronic Tech Co., Ltd.
Celerity Incubator
STERIS Corporation
POINT Kinguide Agile Hybrid Navigation System
Point Robotics MedTech, Inc.
Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)
Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd
Aevumed PHANTOM-LP Suture Anchors
Aevumed, Inc.
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 0
Infraredx, Inc.
HemoSphere Nano Monitor (HSNANO1)
Edwards Lifesciences, LLC
VR® Personal Protective Level 3 Gown (VR Gowns)
PolyConversions, Inc.
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL
Thermo Fisher Scientific
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Brosmed Medical Co., Ltd.
TOMTEC-ARENA
Tomtec Imaging Systems GmbH
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
Tigon Medical
Powered Muscle Stimulator (Model name:MagGraver F200)
Nanjing Vishee Medical Technology Co., Ltd.
Clarius Ultrasound Scanner
Clarius Mobile Health Corp.
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