Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Burkhart Varnish 5% Naf Cherry 0.4mL (50)

FDA UDI

BURKHART DENTAL SUPPLY CO., THE·00854212006776·

WONDERFUL 5% NAF VARNISH CLEAR MINT SINGLES

FDA UDI

YOUNG DENTAL MANUFACTURING I, LLC·10302732959883·100ct

WONDERFUL 5% NAF VARNISH CLEAR BUBBLEGUM SINGLES

FDA UDI

YOUNG DENTAL MANUFACTURING I, LLC·10302732959876·100ct

WONDERFUL 5% NAF VARNISH CLEAR STRAWBERRY SINGLES

FDA UDI

YOUNG DENTAL MANUFACTURING I, LLC·10302732959890·100ct

Burkhart Varnish 5% NaF Mint 0.4mL (50)

FDA UDI

BURKHART DENTAL SUPPLY CO., THE·00854212006783·

Burkhart Varnish 5% NaF Melon 0.4mL (50)

FDA UDI

BURKHART DENTAL SUPPLY CO., THE·00854212006769·

WONDERFUL 5% NAF VARNISH WHITE CHOCOLATE SINGLES

FDA UDI

YOUNG DENTAL MANUFACTURING I, LLC·10302732959869·100ct

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi

CELLSTOR POT - 20ml i 40ml baegar - (10% NBF) (HOUNISENS)

Device

EU IVDR · Eu Ivd Class A ·CellPath Ltd·On the market

ATRIUM'S HYBRID PTFE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISTAFLO BYPASS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MARKII VENTIMASKS

FDA 510(k)

FDA Class 1 ·Anesthesiology

VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC

FDA 510(k)

FDA Class 1 ·Anesthesiology

VENTURI MASK/DELIVERY SYSTEM #'S

FDA 510(k)

FDA Class 1 ·Anesthesiology

VASCULAR GRAFT PROST. OF EXPANDED PTFE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARNATION TRACHEOSTOMY MASKS

FDA 510(k)

FDA Class 1 ·Anesthesiology

AIR ENTRAINMENT TRACH T

FDA 510(k)

FDA Class 1 ·Anesthesiology

FEP-RINGED GORE-TEX@ VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular