TACTIPEN

FDA 510(k)

FDA Class 2 ·General Hospital

OKAMOTO STUDDED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROVISION SCLERAL BUCKLING COMPONENTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPECTRUM V.0

FDA 510(k)

FDA Class 2 ·Radiology

SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY

FDA 510(k)

FDA Class 2 ·Dental

SMILEBOND SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MRI MARKER

FDA 510(k)

FDA Class 2 ·Radiology

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM Septal Occluder

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM

FDA Pre-Market Approval

HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM AVT AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE

FDA 510(k)

FDA Unclassified ·Unknown

K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR

FDA 510(k)

FDA Class 2 ·General Hospital