Adapta®

FDA UDI

MEDTRONIC, INC.·00643169474208·IPG ADSR01 ADAPTA US MKT

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW

Ovy GmbH

Importer

🇩🇪 Germany

IP85095 x10: Sterile, Single Use, CHALAZION SET OOZ

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET

FDA Pre-Market Approval

Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack

CDA Haler 45 x 2.25 x 3.5 - O - V3

Basic UDI-DI

EU MDD · Eu Md Class 1 ·EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.·1 device

CDA Haler 45 x 1.00 x 3.5 - O - V3

Basic UDI-DI

EU MDD · Eu Md Class 1 ·EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.·1 device

Relia IPG

FDA registration

MEDTRONIC, INC.·5 products·🇺🇸 United States

Suture Sleeve Accessory DS2A088

FDA registration

ABBOTT MEDICAL·5 products·🇺🇸 United States

Renamic

FDA registration

BIOTRONIK, INC.·5 products·🇺🇸 United States

Suture Sleeve Accessory DS2A088

FDA registration

Abbott Medical·5 products·🇺🇸 United States

Relia IPG

FDA registration

MEDTRONIC SOFAMOR DANEK USA, INC.·5 products·🇺🇸 United States

PRO-TECH DESIGN & MFG., INC.

FDA registration

PRO-TECH DESIGN & MFG., INC.·5 products·🇺🇸 United States