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
Injection Needle
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
ZENEX Implant System_R-System
Izenimplant Co., Ltd.
Motive Muscle Stimulator for Lower Back (OT01-1003)
Motive Health, Inc.
VasQ
Laminate Medical Technologies , Ltd.
Prestige Coil System (Prestige Packing Line Extension)
Balt USA, LLC
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model
STERIS Corporation
Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Boston Scientific
Irrisept Antimicrobial Wound Lavage
Irrimax Corporation
CINA-VCF
Avicenna.Ai
YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
SmartBolus Calculator
Insulet Corporation
Spineology Navigation Instruments
Spineology, Inc.
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UN
Smith and Nephew, Inc.
APRO 35 Swift Catheter and Alembic Aspiration Tubing
Alembic, LLC
da Vinci Firefly Imaging System
Intuitive Surgical, Inc.
MAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.
ODI-Tech
Odi Medical AS
Rezum System
Boston Scientific Corporation
EmbedMed
3D Lifeprints UK , Ltd.
IPL Hair Removal Device
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
Infusion Sets for Single Use with Needles
Sichuan Prius Biotechnology Co., Ltd.
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
Greens Surgicals Pvt. , Ltd.
ACCLARENT AERA Eustachian Tube Dilation System
Acclarent, Inc.
CONDUIT SYNFIX Evolution Secured Spacer System
Avalign Technologies, Inc.
OpenTex
Purgo Biologics, Inc.
maxmorespine Bipolar Electrodes
Hoogland Spine Products, GmbH
BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets
Becton, Dickinson and Company
Kerecis Parvus (50207)
Kerecis Limited
Nitrile Examination Gloves
Hangzhou Runheng Medical Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert