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
UroLift System Rigid Retrieval Kit Sterilization Tray
Neotract, Inc.
GIA Stapler with Tri-Staple Technology
Covidien
Sunny
ShenB Co., Ltd.
Lumina-PTFE Titanium
Criteria Industria E Comercio DE Produtos Medicinais
ID NOW Influenza A & B 2
Abbott Diagnostics Scarborough, Inc.
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
Olympus Medical Systems Corp.
Vista BC Putty
Inter-Med, Inc.
TRANBERG Thermoguide Therapy System
Clinical Laserthermia Systems, AB
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
Vinno Technology (Suzhou) Co.,Ltd
JARVIS Glenoid Reverse Shoulder Prosthesis
FH Industrie
Twist Drills
Biomet Microfixation
GECHO
Narnar, LLC
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
Terragene S.A.
DEKA ACE Pump System
Deka Research and Development
SmileInspector
Amv Consulting, LLC
AIR COMPRESSION BOOTS 1018195,1018196
Merchsource, LLC
Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo
Bard Access Systems, Inc.
Pantheon Pedicle Screw and Iliac Bolt Fixation System
Pantheon Spinal
Synthetic Bone Putty
Ventris Medical
Capsule Surveillance System
Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.
PDO Max Suture with Dual Needle
Pdo Max, Inc.
Tyvek Roll with CI for STERLINK Sterilizer
Plasmapp Co,., Ltd.
Single-Use Flexible Rhinolaryngoscope
Hunan Vathin Medical Instrument Co., Ltd.
Altus Spine Monaco Pedicle Screw System
Altus Spine
IMAGE1 (TC400US); X-to-4U Adapter (TC040)
Karl Storz SE & CO. KG
AuST Steerable Sheath
CenterPoint Systems, LLC
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement
Imaxeon Pty, Ltd.
Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Guangzhou Red Pine Medical Instrument Co., Ltd.
Auxilock Titanium Interference Screw
Auxein Medical Private Limited
Forcyte Autograft Harvest Kit
Forcyte Medical, LLC
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