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
RAP Femoral Venous Cannulae
LivaNova USA, Inc.
HD-550 Video Endoscope System
Sonoscape Medical Corp.
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
Megagen Implant Co., Ltd.
Dentsply Sirona Titanium Bases system
Dentsply Sirona
Diode Laser Hair Removal System
Beijing Winkonlaser Technology Limited
Minimally Invasive Prostate Surgery Navigation System
Augment Intelligent Medical System (China) Co., Ltd.
Medical Examination Gloves
Shandong Huiwosheng Health Technology Co.,Ltd
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
Shenzhen Kentro Medical Electronics Co., Ltd.
AutoContour (RADAC V5)
Radformation, Inc.
ECHO Photocoagulator
Norlase
Cleo
American Orthodontics
OC JuggerKnot Soft Anchor
Riverpoint Medical
CYLOX® ST
Signus Medizintechnik GmbH
Vivid Explorer/Vivid Advanced/Vivid Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for
Summit Glove, Inc.
VERTICALE® Navigation Instruments
Silony Medical GmbH
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
Philips Medical Systems Nederland B.V.
BriefCase-Triage
Aidoc Medical , Ltd.
Ai Ray Dental X-Ray Device
Guilin Woodpecker Medical Instrument Co., Ltd.
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Linshom Medical, Inc.
Arm Blood Pressure Monitor
Andon Health Co, Ltd.
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Jiujiang Taixin Technology Co., Ltd.
Nerivio; Nerivio Infinity
Theranica Bio-Electronics, Ltd.
INVOcell Intravaginal Culture System
Invo Bioscience
Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFl
Pulnovo Medical (Wuxi) Co., Ltd.
BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
C.R. Bard, Inc.
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
Micropace Pty, Ltd.
Stent Positioning Assistance System (SPAS)
Seven Sons , Ltd.
KARL STORZ ICG Imaging System with RUBINA® Lens
Karl Storz SE & CO. KG
EffortMed Spinal Fixation System
Effortmed, LLC
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert