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
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Jiangxi Maidikang Medical Devices Co., Ltd.
QUEX ED; QUEX S
Qx World, Ltd.
Universal Pilot Guidance Instrument System
Ctl Medical Corporation
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
Cepheid
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
Co-Innovation Biotech Co., Ltd.
TENS & EMS Device
Shenzhen Jian Feng Electronic Technology Co., Ltd.
Da Vinci Monopolar and Bipolar Adapters (378896)
Intuitive Surgical
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
Tianjin Huahong Technology Co., Ltd.
TriALTIS Spine System
Medos International SARL
APO-Easy Genotyping kit
Firalis SA
Airbile-100
Poskom Co., Ltd.
Lancing System, Sterile Lancet for Single Use, Lancing Device
Shandong Lianfa Medical Plastic Products Co. , Ltd.
Single Use Cytology Brush V (BC-V600P-3010)
Olympus Medical Systems Corporation
CUVIS-spine
Curexo, Inc.
UV5000 Handle
Uroviu Corporation
Patriot SI Implant System
Spinal Simplicity, LLC
Soft Palate Elevator
The Tmj Clinic PC
IV Administration Set
B.Braun Medical, Inc.
PerfusionGo Plus
Yukun (Beijing) Technology Co., Ltd.
Grappler Suture Anchor System
Paragon 28, Inc.
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
Diversatek Healthcare
OR3O Dual Mobility Liners
Smith & Nephew, Inc.
Constellation (CON-001)
Q Bio, Inc.
Verisafe Safety Retractable Insulin Syringes
Promisemed Hangzhou Meditech Co., Ltd.
Plum Vagiceuticals Vaginal Moisturizing Suppositories
PCCA, Inc.
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Unistik® ShieldLock, Unistik VacuFlip
Owen Mumford, Ltd.
Prospera Spectruum Negative Pressure Wound Therapy System
Deroyal Industries, Inc.
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fenta
Mah Sing Healthcare Sdn. Bhd.
EXALT Model B Single-Use Bronchoscope
Boston Scientific Corporation
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