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
10HQ701G-B
Lg Electronics.Inc
BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
Becton, Dickinson and Company
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Hivox Biotek, Inc.
LuxCreo Clear Aligner System
LuxCreo, Inc.
Venue Sprint
GE Medical Systems Ultrasound and Primary Care Diagnostics
NUVENTUS NV.C Prosthetic Components
Infinitum Eta, Ltd.
EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
Encore Medical L.P.
BNLE Hydrophilic Jacketed Peripheral Guidewire
Biomerics Nle
Bunkerhill Abdominal Aortic Quantification (AAQ)
BunkerHill Health
Nitrile Examination Gloves
Emerald Glove Manufacturing Sdn Bhd
Air Pressure Therapy System
Xiamen Weiyou Intelligent Technology Co., Ltd.
Promisemed X-Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd.
AlphaID At Home Genetic Health Risk Service
Progenika Biopharma S.A., A Grifols Company
CombiSet Hemodialysis Blood Tubing Set
Fresenius Medical Care Renal Therapies Group, LLC
Access SHBG
Beckman Coulter, Inc.
FRONT-LINE Field Sterilizer (FL135)
Fort Defiance Industries, LLC
NobelProcera Zirconia Implant Bridge
Nobel Biocare AB
INOUE BALLOON A
Toray Industries, Inc.
Centerpiece Plate Fixation System
Medtronic Sofamor Danek
VersaCross Connect Transseptal Dilator
Baylis Medical Company, Inc.
Elos Accurate® Denture Fixation System
Elos Medtech Pinol A/S
Galileo Vertebral Body Replacement Device
Bright Spine
Oral Matrix
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
Q-Switched Nd: YAG Laser System (Glamor Q)
Nanjing Bestview Laser S&T Co., Ltd.
Mobility Scooter (W3331)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
HyperFlex Bunion Correction System
Footbridge Medical
DEKA SMARTPERIO
El.En Electronic Engineering Spa
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Pol
Safepath Medical, Inc.
easy Claire
Y & J Bio Co., Ltd.
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
Wuhan Guangdun Technology Co.,Ltd..
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert