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
Silver Fluoride Hypersensitivity Varnish
Young Dental Manufacturing Co. 1, LLC
SUREcore Plus Biopsy Instrument
Uro-1, Inc.
Koios DS
Koios Medical, Inc.
Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation
TeleScan
Bb Imaging
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Cathete
Medsource International, LLC
Cardinal Health Nitrile Examination Gloves Extended Cuff
Cardinalhealth
VySpan PCT System
Vy Spine, LLC
YO Home Sperm Test
Medical Electronic Systems , Ltd.
AlphaVent Knotless SP PEEK Anchor
Stryker Endoscopy
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
L&K BIOMED Co., Ltd.
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked
Access Vascular, Inc.
ClearPoint Array System (Version 1.2)
ClearPoint Neuro, Inc.
Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
Covidien, LLC
Phototherapy System (DUV-COMBO)
Choyang Medics Co., Ltd.
Kinos Total Ankle System
Restor3D
SonoAir Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd.
ZenPro 40
BLUECORE COMPANY Co., Ltd.
Layer 7-T
Precision Neuroscience, Corp.
OSSTM Orthopedic Salvage System
Biomet, Inc.
Medical Face Mask
Haian Medigauze Co., Ltd.
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Kj Meditech Co., Ltd.
Access EPO
Beckman Coulter, Inc.
Medline Integrated Arterial Catheter
Centurion Medical Products
VenusX
Linatech, LLC
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Better Care Plastic Technology Co., Ltd.
Accuro® 3S Needle Guide Kit
Rivanna Medical, Inc.
Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
OrthoPediatrics Corp.
RADIANCE ULTRA 32 4K ZEROWIRE DUO
Nds Surgical Imaging, LLC
Disposible Nitrile Gloves
Holik Asia Group Co.,Ltd
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