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
VariTrax Sternal CircumFixation System
Circumfix Solutions, Inc.
Cold Sore Device (QPZ-03)
Shenzhen Nuon Medical Equipment Co., Ltd.
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introd
William Cook Europe Aps
Jazz Classic
Jazz Imaging
SpeedCath Compact Male
Coloplast
Curiteva Porous PEEK Standalone ALIF System
Curiteva, Inc.
LiverMultiScan v5 (LMSv5)
Perspectum
Medical Face Masks, Model Name:MY020003
Huizhou Jie Bai Purification Co., Ltd.
Newclip Patient-matched instrumentation non sterile PSI
Newclip Technics
X-PAC® N-GAGE Lumbar Plate System
Expanding Innovations, Inc.
TearRepair Liquid Skin Protectant
Optmed, Inc.
Zilia Ocular FC (ZIL-10002)
Zilia, Inc.
Cobra Catheter System
Endovascular Engineering
Careflux H60;Careflux H70;Careflux V500
Fresenius Medical Care Renal Therapies Group, LLC
CORIS System
Nanosonics Limited
AMC Health CareConsole
Amc Health
Sterisystem Dry-Base Instrument Tray
O&M Halyard, Inc.
Sway System Sports Plus
Sway Medical, Inc.
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
Ellex Medical Pty, Ltd.
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
Pureway Compliance, Inc.
Biocore9 Acetabular Cup System
Biocore9, LLC
Disposable Warming Blanket
Hangzhou Tappa Medical Technology Co., Ltd.
Lavieen
Wontech Co., Ltd.
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Steril
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
Invictus® Spinal Fixation System
Alphatec Spine, Inc.
CIRRUS HD-OCT Model 6000
Carl Zeiss Meditec, Inc.
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Immuno Concepts, N.A. , Ltd.
CERAMENT G
Bonesupport AB
allay Nerve Cap
Tulavi Therapeutics
MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert