Spatz3 Adjustable Balloon System

Device

EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·On the market·20 countries

AMIS*PACS FLEXSERVER G2

Device

EU MDD · Eu Md Class 2b ·ICZ.HEA a.s.·On the market·2 countries

FX Shoulder Solutions

Authorized representative

🇫🇷 France·1 Manufacturer

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Sperm, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Sperm, Fitc, Antigen, Antiserum, Control

Mirror, Mouth

FDA classification

FDA Class 1 ·Mirror, Mouth

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020061·Laryngectomy Pulmonary Kit 10/55 W/ Provox Vega...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020566·2010C-02 Laryngectomy Pulmonary Kit 9/55 With P...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020993·2010-074 Laryngectomy Pulmonary Kit with Standa...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020788·2010C4-02 Laryngectomy Pulmonary Kit with Stand...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020924·2010-067 Laryngectomy Pulmonary Kit with Standa...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020948·2010-069 Laryngectomy Pulmonary Kit with Standa...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020832·2010-061 Laryngectomy Pulmonary Kit with Standa...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020849·2010-062 Laryngectomy Pulmonary Kit with Standa...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020894·2010-064 Laryngectomy Pulmonary Kit with Standa...

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020863·2010-13 Laryngectomy Pulmonary Kit With Standar...

Rauscher Consumer Products GmbH

Importer

🇦🇹 Austria·2 Manufacturers

Organ Care System (Ocs) Heart System

FDA classification

FDA Class 3 ·Organ Care System (Ocs) Heart System

efi Sports Medicine (GmbH & Co.) KG

Importer

🇩🇪 Germany

ECG Electrodes

Basic UDI-DI

EU MDR · Eu Md Class 1 ·EF Medica Srl·172 devices