PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

PATIENT EXAMINATION GLOVE (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

ALBAcyte Orr cells

FDA UDI

ALBA BIOSCIENCE LIMITED·05060242471155·2-3% Reagent Red Blood Cells for ABO Reverse Gr...

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft/Medtronic Interbody Fusion Device

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

ISOMEDIX OPERATIONS INC.

FDA registration

ISOMEDIX OPERATIONS INC.·2 products·🇺🇸 United States

WellsForm Tricuspid Annuloplasty Band

FDA registration

GENESEE BIOMEDICAL, INC.·2 products·🇺🇸 United States

TransForm McCarthy Mitral Annuloplasty Ring

FDA registration

GENESEE BIOMEDICAL, INC.·2 products·🇺🇸 United States

CytoSorbents Inc.

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·2 Devices·2 Importers·DEKRA Certification B.V.

Ablative Solutions Inc.

Manufacturer

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

Aziyo Biologics, Inc.

Manufacturer

🇺🇸 United States·11 Basic UDI-DIs·11 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

North Coast Medical Inc.

Manufacturer

🇺🇸 United States·5 Basic UDI-DIs·9 Devices·1 Importer

Osprey Medical Inc.

Manufacturer

🇺🇸 United States·7 Importers

Cardiac Dimensions, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·78 Devices·DEKRA Certification B.V.

Inspire Medical Systems Inc

Manufacturer

🇺🇸 United States·1 Importer

ZAP Surgical Systems, Inc.

Manufacturer

🇺🇸 United States·2 Importers

Allurion Technologies Inc.

Manufacturer

🇺🇸 United States·8 Basic UDI-DIs·8 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Venclose, Inc.

Manufacturer

🇺🇸 United States·9 Basic UDI-DIs·9 Devices·3 Importers·DNV Product Assurance AS

BT KINISI 8 1/4 RH EU WRIST

Device

EU MDR · Eu Md Class 1 ·Hugh Steeper Limited·On the market