JACE MODEL 100 KNEE CPM DEVICE

FDA 510(k)

FDA Class 1 ·Physical Medicine

JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION

FDA 510(k)

FDA Class 1 ·Physical Medicine

IMPLANT CENTER 2

FDA 510(k)

FDA Class 2 ·Dental

AIRTEC2 LOW AIR LOSS THERAPY BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

AIR-N-GO

FDA 510(k)

FDA Class 1 ·Dental

VIVO

FDA 510(k)

FDA Class 2 ·Cardiovascular

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

AMT G-Jet® Winged Luer Adapter with Syringe

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071106904·Winged Luer with Syringe (Pouched) - For Direct...

AMT Kreienbaum GmbH

Importer

🇩🇪 Germany

2195-MED-1317901

Certificate

MDD Annex II (excluding section 4)·DMS CO., LTD.·Szutest Uygunluk Değerlendirme A.Ş.·5 Basic UDI-DIs

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Daniels Medizintechnik GmbH&Co.KG

Importer

🇩🇪 Germany·1 Manufacturer

Central Dental Compressed Air and Aspiration System

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DMS DENTAL MEDIKAL SANAYI VE TICARET ANONIM SIRKETI·3 devices

Central Dental Compressed Air System

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DMS DENTAL MEDIKAL SANAYI VE TICARET ANONIM SIRKETI·3 devices

Central Dental Aspiration System

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DMS DENTAL MEDIKAL SANAYI VE TICARET ANONIM SIRKETI·8 devices

G10314610036

Certificate

MDD Annex II (excluding section 4)·BMT Medical Technology s.r.o.·TÜV SÜD Product Service GmbH·10 Basic UDI-DIs

AMT Aromando Medizintechnik GmbH

Importer

🇩🇪 Germany·4 Manufacturers

IMT Analytics GmbH

Authorized representative

🇱🇮 Liechtenstein·1 Manufacturer·2 Devices