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
Tulsa Pro System (Pad-105)
Profound Medical, Inc.
CONNEQT PULSE
Atcor Medical
Nu Skin RenuSpa iO
Nse Products, Inc.
DWFritz ASM2000
Dwfritz Automation, Inc.
Derma-R Cream (Derma-R Cream)
Raya Pharmaceuticals, LLC
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
Shanghai AnQing Medical Instrument Co., Ltd.
OptiVu ROSA® MxR
Orthosoft Inc (D/B/A Zimmer Cas)
geko W-3
Firstkind Limited
InVision 1.5 Surgical Theatre
Deerfield Imaging, Inc.
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
Innovative Health, LLC
Flexible Suturing System with Anchors (FSSA)
Integrity Orthopaedics, Inc.
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fent
Mercator Medical (Thailand), Ltd.
N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH
Agile Esophageal OTW Stent System
Boston Scientific Corporation
iiSure Infusion Set
Deka Research and Development
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel P
Shenzhen Yongquan Medical Devices Co., Ltd.
Curiteva Navigation System
Curiteva, Inc.
MIS Precision Chevron Bunion System
Relja Innovations, LLC
Helios Dura Regeneration Matrix
Helios Biomedical, Inc.
SureAx-Guide
Sureax Medical, LLC
Lipids
Truvian Health
Power Wheelchair
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Integra Lifesciences Production Corporation
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
BIOMERIEUX
Onetouch Non-paraben Lubricant Gel
Thai Nippon Rubber Industry Public Company Limited.
Clever One
Ewoosoft Co., Ltd.
Traumatic brain injury (TBI) test
Abbott Laboratories
EPORE® XO cup system
Implantcast GmbH
Intermittent Catheter (Not Finalized)
Hollister Incorporated
TaperSet Hip System
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert