RecallHawk

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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