Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat (MCH) Flour, Avitene Microfibrillar Collagen Hemostat (MCH) SyringeAvitene, and

Coroneo Inc.

Manufacturer

🇨🇦 Canada·49 Basic UDI-DIs·49 Devices·2 Importers·GMED SAS and GMED SAS

BIOMEDICAL TISSUES

Manufacturer

🇫🇷 France·8 Basic UDI-DIs·8 Devices·GMED SAS and GMED SAS

ECENTIAL ROBOTICS

Manufacturer

🇫🇷 France·3 Basic UDI-DIs·3 Devices·GMED SAS and GMED SAS

EDAP TMS FRANCE

Manufacturer

🇫🇷 France·11 Basic UDI-DIs·11 Devices·GMED SAS and GMED SAS

S.M.A.I.O

Manufacturer

🇫🇷 France·488 Basic UDI-DIs·488 Devices·GMED SAS and GMED SAS

ARCADOPHTA

Manufacturer

🇫🇷 France·8 Basic UDI-DIs·8 Devices·GMED SAS and GMED SAS

MEDIPREMA

Manufacturer

🇫🇷 France·4 Basic UDI-DIs·6 Devices·GMED SAS and GMED SAS

OriGen Biomedical Inc.

Manufacturer

🇺🇸 United States·120 Basic UDI-DIs·120 Devices·2 Importers·GMED SAS and GMED SAS

PARSYS TELEMEDECINE

Manufacturer

🇫🇷 France·3 Basic UDI-DIs·3 Devices·GMED SAS and GMED SAS

ETABLISSEMENT FRANCAIS DU SANG

Manufacturer

🇫🇷 France·3 Basic UDI-DIs·3 Devices·GMED SAS and GMED SAS

MED-Fibers, Inc.

Manufacturer

🇺🇸 United States·88 Basic UDI-DIs·88 Devices·GMED SAS and GMED SAS

Cisbio Bioassays

Manufacturer

🇫🇷 France·57 Basic UDI-DIs·57 Devices·GMED SAS and GMED SAS

NANOBIOTIX

Manufacturer

🇫🇷 France·1 Basic UDI-DI·1 Device·GMED SAS and GMED SAS

THERMOSHIELD HME FILTER

FDA registration

FLEXICARE MEDICAL (DONGGUAN) LTD.·1 product·🇨🇳 China

Bacteria Filter

FDA registration

AIRON CORPORATION·1 product·🇺🇸 United States

AIR SAFETY HEPA AND NON-HEPA FILTERS

FDA registration

BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A.·1 product·🇨🇷 Costa Rica

Filta-Guard & Filta-Therm Breathing Filters, 1942000,1944000

FDA registration

UAB INTERSURGICAL·1 product·🇱🇹 Lithuania

Filter, bacterial, breathing-circuit

FDA registration

PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.·1 product·🇲🇽 Mexico

Filter, Bacterial, Breathing - Circuit - DeRoyal

FDA registration

DEROYAL INDUSTRIES, INC.·1 product·🇺🇸 United States