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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

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (2

Kirwan Surgical Products, LLC

Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/m

Belmont Medical Technologies

Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)

Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.

Huma RPM (RPM)

Medopad, Inc.

INFRARED BODY THERMOMETER (Model: YK-001)

Longnan Renzhong Medical Equipment Co., Ltd.

DenMat Bulk Fill Composite

Den-Mat Holdings, LLC

8ch Wrist Coil

Shenzhen RF Tech Co., Ltd.

Straumann CARES Visual and Nova Dental CAD

Institut Straumann AG

WasherCap™ Mini Fixation System (Model 45)

Abanza Tecnomed S.L

Bladeless Trocar; Bladed Trocar; Hasson Trocar

Advamedix, GmbH

KNH Surgical Face Mask

Knh Surgical Face Mask

INNOVANCE VWF Ac

Siemens Healthcare Diagnostics Products GmbH

MolecuLightDX

MolecuLight, Inc.

Dentis s-Clean Abutment Mini

Dentis Co., Ltd.

D²RS and D²RS 9090

Stephanix

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)

Covidien

Kerecis Oral

Kerecis

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

Sonova AG

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

Artivion, Inc.

Face Patches (MT-12MA, MT-12MC)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Infinity Gateway Suite

Draeger Medical Systems, Inc.

MirrorMe3D Modeling System

Mirrorme3D, LLC

Inbentus Versatile

Iconic Solutions by Murcia, SL

PrimeTaper EV Dental Implant

Dentsply Sirona, Inc.

Xpert® FII & FV

Cepheid

ArthroFree Wireless Surgical Camera System

Lazurite Holdings, LLC

Trevo NXT ProVue Retriever

Stryker Neurovascular

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves

American Nitrile Operations, LLC

BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx

Vivachek Biotech (Hangzhou) Co., Ltd.

VVR Generator system

Starmed Co., Ltd.

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