Suprasorb A + Ag “R”

FDA 510(k)

FDA Unclassified ·Unknown

OSTEOBOOST-BMA

FDA 510(k)

FDA Class 2 ·General Hospital

BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID

FDA 510(k)

FDA Class 2 ·Orthopedic

Titan Ag 200

FDA 510(k)

FDA Unclassified ·Unknown

SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OrbusNeich Medical, B.V.

Manufacturer

🇳🇱 Netherlands·508 Basic UDI-DIs·508 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Nagor Limited

Manufacturer

240 Basic UDI-DIs·240 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Spectranetics Corporation

Manufacturer

🇺🇸 United States·198 Basic UDI-DIs·198 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

OrbusNeich Medical (Shenzhen) Co.,Ltd

Manufacturer

🇨🇳 China·1058 Basic UDI-DIs·1058 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Silicone-Filled Breast Implants

United Orthopedic Corporation

Manufacturer

🇹🇼 Taiwan·2849 Basic UDI-DIs·3043 Devices·5 Importers·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., Szutest Uygunluk Değerlendirme A.Ş., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

LGC Clinical Diagnostics, Inc.

Manufacturer

🇺🇸 United States·84 Basic UDI-DIs·84 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

MEDENTiKA

FDA UDI

MEDENTiKA GmbH·EMKAEV16402SF9·Titanium base ASC Flex incl. Abutment screw

MEDENTiKA

FDA UDI

MEDENTiKA GmbH·EMKAEV16202SF9·Titanium base ASC Flex incl. Abutment screw

MEDENTiKA

FDA UDI

MEDENTiKA GmbH·EMKAEV16302SF9·Titanium base ASC Flex incl. Abutment screw

MEDENTiKA

FDA UDI

MEDENTiKA GmbH·EMKAEV16102SF9·Titanium base ASC Flex incl. Abutment screw

Inion Oy

Manufacturer

🇫🇮 Finland·812 Basic UDI-DIs·1028 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., Kiwa Dare B.V., and BSI Group The Netherlands B.V.

Volcano Corporation

Manufacturer

🇺🇸 United States·30 Basic UDI-DIs·30 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERES MICROSPHERES

CoaguSense Inc.

Manufacturer

🇺🇸 United States·4 Basic UDI-DIs·4 Devices·BSI Assurance UK Ltd, BSI Assurance UK Ltd, and BSI Assurance UK Ltd