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
Purgo
Aeroclean Technologies, LLC
OSSIOfiber® Threaded Trimmable Fixation Nail
OSSIO , Ltd.
Idylla MSI Test
Biocartis NV
FlexCath Cross Transseptal Solution
Acutus Medical, Inc.
Natus BrainWatch System
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
AiORTA - Plan v2.0
ViTAA Medical Solutions, Inc.
iFuse-TORQ® Implant System
SI-BONE, Inc.
Methinks CTA Stroke
Methinks Software, S.L
VersaCross Connect Transseptal Dilator
Baylis Medical Company, Inc.
Erchonia DPN Laser (Model# EVRL)
Erchonia Corporation
neXus Ultrasonic Surgical Aspirator System
Misonix, LLC
Internal Locking Plate and Screw Fixation System
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syri
Kettenbach GmbH & Co. KG
Micro Rx
Imds Operations B.V.
Advanced LumFix Spinal Fixation System
CG Bio Co., Ltd.
LOWTEM Crystal 120
Lowtem Co., Ltd.
LightningWire Transseptal Puncture System (TPS)
ElectroWire Medical
geko W-2
Firstkind Limited
Vista Ophthalmics Vitrectomy Probe
Vista Ophthalmics, LLC
DynaNail Mini Tapered Hybrid
MedShape, Inc.
Sterile Hypodermic Syringes for Single Use with Safety Needles
Sichuan Prius Biotechnology Co., Ltd.
Plain Water-based Lubricant
Global Protection Corp.
Tyto Stethoscope (G3)
Tyto Care , Ltd.
HP358EA Electrically Powered Wheelchair
Kunshan Hi-Fortune Health Products Co., Ltd.
eCO2 3D
Lutronic Corporation
Electric wheelchair (S7018)
Guangdong Prestige Technology Company Limited
HARBOR Occlusion Device
Nuvascular, Inc.
2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor
Medos International SARL
Infinity OCT System
Medtronic Sofamor Danek USA, Inc.
Soteria E-View
Omega Medical Imaging, LLC
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