DURA-PATCH MODEL DP-XXX

FDA 510(k)

FDA Class 2 ·Neurology

EZTEST-STEAM

FDA 510(k)

FDA Class 2 ·General Hospital

PROLITE III TOWER AND PR AND HR HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-spine Cortical Bone Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cortera™ Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ALLOX2 TISSUE EXPANDERS

FDA 510(k)

FDA Unclassified ·Unknown

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

ACCOMMODATOR WHEELCHAIR, MODEL #2000X

FDA 510(k)

FDA Class 1 ·Physical Medicine

MODIFICATION TO FLUROTEX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAMMARY SIZER

FDA 510(k)

FDA Unclassified ·Unknown

VIRILIS PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILICONE ELASTOMER SHEETING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO FLUOROTEX II SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LATEX EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

VAX-T PELVIC TRACTION BELT

FDA 510(k)

FDA Class 2 ·Physical Medicine

BEMCO PORTABLE OXYGEN INHALATOR

FDA 510(k)

FDA Class 1 ·Anesthesiology

AMT Kreienbaum GmbH

Importer

🇩🇪 Germany

Daniels Medizintechnik GmbH&Co.KG

Importer

🇩🇪 Germany·1 Manufacturer

G10314610036

Certificate

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