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
NextDent Ortho Flex
Vertex-Dental B.V.
LUOFUCON® Antimicrobial Wound Gel
Huizhou Foryou Medical Co., Ltd.
ibiomedi Electronic Stethoscope ES-2020
Sound Land Corp.
Wearable Breast Pump (Model S12)
Shenzhen TPH Technology Co., Ltd.
Velacur
Sonic Incytes
MateLaser Medical Diode Laser Systems (ML-DLS-30)
Matelaser, Inc.
ProKnow DS
Elekta Solutions AB
Disposable Medical Examination Nitrile Gloves
Raxwell Industrial, LLC
BiliWrap
Gerium Medical, Ltd.
Self-Forming Magnet (Flexagon Plus OTOLoc)
GI Windows, Inc.
ANTHEM® Fracture System
Globus Medical, Inc.
SuturePatch Tissue Reinforcement
Arthrex, Inc.
Ceribell Neurology Review Software
Ceribell, Inc.
Avara Viewer
Avara Software
Alegria Flash CTD Screen
Zeus Scientific
EksoNR
Ekso Bionics, Inc.
PELNAC Meshed Bilayer Wound Matrix
Gunze Limited
Yumizen H2500
HORIBA ABX SAS
Libre Rio Continuous Glucose Monitoring System
Abbott Diabetes Care
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
Scientia Vascular, LLC
Camber Spine Navigation System
Camber Spine Technologies
Perin Health System (PHD80060-2)
Perin Health Devices, LLC
HOPKINS Telescopes
Karl Storz Endoscopy America, Inc.
Ahmed® Glaucoma Valve Model FP7
New World Medical, Inc.
Hope&Her Vaginal Dilators
Lujena, Inc.
Stryker Steri-Shield 8 Surgical Hoods and Togas
Stryker Instruments
Skanmobile, Skanmobile-Dr
Skanray Technologies Limited
Belun Sleep System BLS-100
Belun Technology Company Limited
V-Patch Cardiac Monitor
Shandong Corecare Technology Limited
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
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