SAPPHIRE ST PORTABLE DIODE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DenMat Bulk Fill Composite

FDA 510(k)

FDA Class 2 ·Dental

Nuance FLOW

FDA 510(k)

FDA Class 2 ·Dental

nuance UNIVERSAL

FDA 510(k)

FDA Class 2 ·Dental

SAPPHIRE O/E ORAL EXAMINATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

Simple 2 Test

FDA 510(k)

FDA Class 2 ·Microbiology

Lunoa System

FDA 510(k)

FDA Class 2 ·Dental

ICP TRIAGEMANAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Echotip

FDA UDI

COOK INCORPORATED·00827002182035·Echotip Disposable Amniocentesis Needle

AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

Krebs von den Lungen-6 Kit (Latex-Enhanced Immunoturbidimetric Method)

Device

EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·On the market

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TM) LARGE GRANULAR (LG)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)