15 results · 18ms · Sources: EU EUDAMED, US FDA

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BIOSE INDUSTRIE

Manufacturer
🇫🇷 France·2 Basic UDI-DIs·2 Devices·Eurofins Electric & Electronics Finland Oy

MANC-OUT-NI

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

GYNOPHILUS

Device
EU MDD · Eu Md Class 2a ·BIOSE INDUSTRIE·On the market·9 countries

Gynophilus Restore

Device
EU MDD · Eu Md Class 2a ·BIOSE INDUSTRIE·On the market·7 countries

stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

Gynophilus LP Vaginal Tablet

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BIOSE INDUSTRIE·1 device

Gynophilus, vaginal capsule

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BIOSE INDUSTRIE·1 device

C-01-1170-751-20

Certificate
MDD Annex V·BIOSE INDUSTRIE·Eurofins Electric & Electronics Finland Oy·2 Basic UDI-DIs