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
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
Co-Innovation Biotech Co., Ltd.
Alinity m Resp-4-Plex
Abbott Molecular, Inc.
KARL STORZ Flexible HD Cysto-Urethroscope System
Karl Storz Endoscopy America, Inc.
Digital Thermometer
Wenzhou Yosun Medical Technology Co.,Ltd
Anteralign Spinal System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA, Inc.
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
Wuxi Jiajian Medical Instrument Co., Ltd.
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
Owen Mumford, Ltd.
uWS-Angio Basic
Shanghai United Imaging Healthcare Co., Ltd.
KidneyIntelX.dkd
Renalytix Ai, Inc.
AngioCloud Service
Angiocloud, LLC
Instylla Delivery Kit
Instylla, Inc.
Permatage XT Settable Bone Putty
Orthocon, Inc.
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental
Neuronetics, Inc.
Freedom® Medial Congruent Liner
Maxx Orthopedics, Inc.
Eclipse Blood Collection Set
Eclipse Medcorp, LLC
Vision-MR Diagnostic Catheter
Imricor Medical Systems, Inc.
X-Y Lubricating Jelly
R&R Medical Corporation, Ltd.
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
Oxoid Limited (Part of Thermo Fisher Scientific)
Cannulated Compression Device System
Orthopedic Designs North America, Inc.
Sterile Latex Surgical Gloves Powder Free
Amazing Rubber Products Pvt, Ltd.
Digital Crown
Sprintray, Inc.
MANTA Laser
Squalus Med , Ltd.
XBody Go USA, XBody Pro USA
Xbody Hungary Kft.
i-STAT PTplus Cartridge with the i-STAT 1 System
Abbott Laboratories
InVision Precision Cardiac Amyloid
InVision Medical Technology Corporation
MI View&GO
Siemens Medical Solutions USA, Inc.
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement
Conformis, Inc.
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Shanghai AnQing Medical Instrument Co., Ltd.
Precision1, Precision1 for Astigmatism
Alcon Laboratories, Inc.
InbellaMulti System
Inbella Medical, Inc.
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